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Outcome measures |
Maximum inspiratory pressure (MIP)—was measured using a portable MicroRPM (Respiratory Pressure Meter)6-min walk distance (6-MWD)—a 30 m-long indoor walking corridor was used for this test.Pulmonary function tests—performed using a computerized PFT machine (RMS Helios 401). Under PFT, forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and peak expiratory flow rate (PEFR) were measured | PMC9925741 | ||
Study protocol |
Pre-intervention assessment: Most data were collected after breakfast and lunch (3–5 pm).Maximum inspiratory pressure (MIP): The MIP was measured using a portable MicroRPM machine. The participants were asked to sit comfortably on a chair, hold the instrument with both hands, and close their lips around the mouthpiece. A nose clip was also applied to prevent the air leak from the nose. Participants were asked to exhale as much as possible, then inhale maximally for more than one second. Before the final measurement, participants were asked to familiarize themselves with the procedurePulmonary function tests (PFT): FVC, FEV1, and PEFR were measured. The PFTs were performed using a computerized Pulmonary Function Test Machine (RMS Helios 401). Participants were asked to sit comfortably, and a nose clip was applied. The mouthpiece was placed in the mouth, and participants were asked to close their lips around it. They were asked to inhale as much as they could and then exhale maximally till no further air could be exhaled. Before taking the final measurements, participants were asked to familiarize themselves with the procedure6-min walk distance (6-MWD): Participants were asked not to exert themselves vigorously 2 h before the test. This test was carried out indoors, along a 30 m long flat straight corridor. This distance was marked using two cones. Before starting the test, participants were asked to rest in a chair for 10 min. Then a timer was used and set at 6 min. Instructions were given to the participants. The total distance walked by the participants in 6 min was noted for baseline measurementIntervention: The participants were divided into the Incentive Spirometer (IS) and Threshold Inspiratory Muscle Trainer (TIMT) groups. In group IS and TIMT, inspiratory muscle training was performed using the volume-based IS and TIMT, respectively. In both groups, the intervention was performed for six weeksIncentive spirometer (IS) group: IMT was performed using the PORTEX Coach 2 incentive spirometer in this group. The participants were allowed to sit comfortably. They were asked to hold the spirometer with their hands, exhale normally, and then put the mouthpiece into the mouth with the lips closing it tightly. They were asked to inhale as slowly and deeply as possible and raise the ball in the chamber. At full inspiration, the mouthpiece was removed, followed by 3–5 s of breath-hold and then normal exhalation. This training was performed for 15 min twice a day (a total of 30 min) for six days a weekThreshold inspiratory muscle trainer (TIMT) group: IMT was performed using the Threshold IMT device in this group. Participants were asked to put the mouthpiece into the mouth and put on the nose clips. Initially, training intensity was set at 30% of MIP with progression by 5% of MIP every week. The participants had to inhale from the mouthpiece, hold their breath for 2–3 s, and then exhale. This training was also performed for 15 min twice daily (a total of 30 min) six days a week. This training session also lasted for a total of 6 weeks.Post-intervention assessment: MIP, PFT (FVC, FEV | PMC9925741 | ||
Data analysis | Data from 18 participants, with 9 participants in each group, were analyzed. SPSS statistical software, version 26 (SPSS Inc., Chicago, IL, USA), was used to analyze data. The normal distribution of baseline values of dependent variables (MIP, FVC, FEV | PMC9925741 | ||
Ethics approval and consent to participate | Ethical approval was obtained from the institutional ethics committee of B.J. Medical & College Hospital (File id: GSITESC/24/16). Before initiating any intervention, the risks and benefits of participation were discussed with all participants, who agreed voluntarily and signed the informed consent form. | PMC9925741 | ||
Results | The demographic characteristics and mean values of the dependent variables are presented in Table | PMC9925741 | ||
IS group | Participants in this group showed a statistically significant ( | PMC9925741 | ||
TIMT group | Participants in this group also showed a statistically significant increase ( | PMC9925741 | ||
Discussion | PD, muscle fatigue | RECRUITMENT | The present study aimed to compare the effectiveness of IS versus TIMT, when used for IMT, on lung functions in patients with PD. The results of the present study showed that MIP and 6-MWD improved with both IS and TIMT. No significant differences were observed with any of the techniques for PFT (FVC, FEV1, and PEFR). When both groups were compared, a greater improvement was observed in the TIMT group than in the IS group. When both groups were compared, large effects were observed for the mean difference of MIP (Partial Eta Squared = 0.719) and 6-MWD (Partial Eta Squared = 0.655). Therefore, TIMT has more beneficial effects on MIP and 6-MWD than IS in PD patients.In the literature, it is already reported that in PD, patients have decreased respiratory muscle strength and enduranceIn the present study, baseline values of MIP for Hoehn & Yahr stages 1–3 were 53.33 cmHNo study in our knowledge has used IS and TIMT for IMT and compared their effects in patients with PD; therefore, comparing the present study's findings with other studies is difficult. However, several previous studies have reported the beneficial effects of IMT on respiratory functions. Inzelberg et al. reported improved endurance and strength of the inspiratory muscle in patients with PD after specific IMTIn the present study, no significant improvements were observed in PFTs (FVC, FEV1, and PEFR) in both groups (IS and TIMT). The possible reason for this could be exercise-type specificity. There is evidence that when the same exercise type is used for testing and training, the greatest training effects will occur, called exercise-type specificityGosselink et al. reported other effects of IMT, including decreased perception of discomfort in the respiratory muscles, redistribution of blood flow to the locomotor and respiratory muscles, and delay in respiratory muscle fatigueIn the present study, TIMT has produced better results than IS in improving MIP and 6-MWD. Therefore, the TIMT device is a better choice for IMT than IS in patients with PD. However, if TIMT is challenging to understand and use for these patients, then the physical therapist should start with a simple device that also provides feedback to the patients, which is IS. The mechanism of TIMT is pressure-based loading, and the principle of usage is inspiration against a fixed resistance pressure, which may explain the observed differences between TIMT and IS. This process is comparable to the resistance/weight exercises used to strengthen the extremities' muscles. With the TIMT device, resistance training occurs for the inspiratory muscles, which produces several benefits, including increased muscle strength and endurance, increased oxygen intake by working muscles, and reduced muscle fatigue. All of which will increase functional fitnessIn the present study, the use of IS also, for six weeks, increased MIP and 6-MWD. Some previous studies showed that inspiratory muscle strength increases after IS use due to increased recruitment of motor unitsIn the present study, the average values of 6-MWD were 264.33 and 262.11 m in IS and TIMT groups, respectively. One of the previous studies by Falvo and EarhartNo improvements were observed in the present study in FVC, FEV1, and PEFR in both groups. This means both IS and TIMT failed to improve pulmonary function tests in patients with PD. According to Shei et al. | PMC9925741 |
Limitations | PD | DISEASE | The present study is not without limitations. Since recruited participants belonged to stages 1–3 of the Hoehn and Yahr modified scale and stages 4–5 were excluded, the results of this study cannot be generalized to patients with advanced PD because often more impaired lung functions are observed in later stages of this disease. Therefore, future studies should be performed on patients in the advanced stages of the disease, and those results should be compared with patients in the early stages. Also, long-term follow-up was not performed, it may be possible that observed improvements were short-lived, and after cessation of IS or TIMT training, the respiratory functions may return to baseline level. In addition to the above limitations, the history of anti-Parkinson medications was not considered when recruiting participants. It may be possible that the current use of the medications may have contributed to improvements in patient symptoms. The present study did not perform MIP according to the ATS/ERS guidelines. Due to a lack of resources, in the present study, only MIP, FVC, FEV1, and PEFR were measured; however, the measurement of more variables like maximal voluntary ventilation (MVV), total lung capacity (TLC), residual volume (RV), closing volumes, and FEF | PMC9925741 |
Conclusions | PD | Inspiratory muscle training with IS or TIMT for six weeks improved MIP and 6-MWD in patients with early stages of PD. TIMT was more effective than IS in this population of patients. IS and TIMT did not show improvements in lung function tests (FVC, FEV1, and PEFR). | PMC9925741 | |
Acknowledgements | The authors extend their appreciation to the Deanship of Scientific Research, King Saud University for funding through Vice Deanship of Scientific Research Chairs; Rehabilitation Research Chair. | PMC9925741 | ||
Author contributions | S.F.M.Y. and A.B. conceptualized the study. S.N., A.H.A., and M.K. were involved in supervision. S.F.M.Y. and M.K. wrote the original draft. S.F.M.Y., M.K., and S.N. were involved in data curation, analysis, and final draft review. All authors read and approved the final manuscript. | PMC9925741 | ||
Funding | This study was funded by King Saud University, Deanship of Scientific Research, Vice Deanship of Scientific Research Chairs; Rehabilitation Research Chair. | PMC9925741 | ||
Data availability | The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. | PMC9925741 | ||
Competing interests | The authors declare no competing interests. | PMC9925741 | ||
References | PMC9925741 | |||
Methods | In this online randomised controlled trial, adult participants received one of four intervention messages or a control message. The control message provided information about booster dose eligibility. Intervention messages added to the control message, each using a different persuasive strategy, including: emphasising personal health benefits of booster doses, community health benefits, non-health benefits, and personal agency in choosing vaccination. After the intervention, participants answered items about COVID-19 booster vaccine intention and beliefs. Intervention groups were compared to the control using tests of two proportions; differences of ≥5 percentage points were deemed clinically significant. A sub-group analysis was conducted among hesitant participants. | PMC10237633 | ||
Results | Of the 487 consenting and randomised participants, 442 (90.8%) completed the experiment and were included in the analysis. Participants viewing messages emphasising non-health benefits had the highest intention compared to those who viewed the control message (percentage point diff: 9.0, 95% CI -0.8, 18.8, | PMC10237633 | ||
Data Availability | The data files are available from the Open Science Framework at | PMC10237633 | ||
Introduction | DISEASE | COVID-19 vaccination has been critical for controlling the COVID-19 pandemic by protecting vulnerable individuals from severe disease, safeguarding health systems and helping return society to normal functioning [Suboptimal uptake of COVID-19 booster doses has occurred globally. In Australia, completion of a primary course of COVID-19 vaccine for individuals ≥16 years is >96%, but booster dose (third dose) coverage has stalled at just over 70% [While many factors can contribute to low vaccine uptake, including both access and acceptance barriers, low motivation may continue to act as a barrier to uptake if not addressed [Considering these findings, emphasising motivational factors in persuasive messaging could potentially be a successful strategy to support higher intention to receive a COVID-19 vaccine. There is evidence that persuasive messages can support higher intentions towards vaccination in general [Given the current state of evidence, it remains unclear what types of messages have the greatest effect on intention to receive a booster dose of COVID-19 vaccine. This is especially the case in populations that have experienced relatively low risk of encountering COVID-19, combined with restrictive public health measures. These were the conditions experienced in Australia at the time of this experiment, where COVID-19 case numbers were relatively low during the first two years of the pandemic, while public health restrictions, such as border closures and lockdowns, were applied liberally due to the country’s pursuit of a COVID-19 elimination strategy [ | PMC10237633 | |
Methods | PMC10237633 | |||
Experimental design | This was a parallel group, randomised, controlled, online experiment comparing intention to receive a COVID-19 vaccine booster dose and beliefs about COVID-19 vaccine booster doses between subjects after receiving persuasive message interventions. This study obtained ethics approval from the Sydney Children’s Hospitals Network Human Research Ethics Committee (2021/ETH00181). The study aims, methods, and data analysis plan were pre-registered on the Open Science Framework ( | PMC10237633 | ||
Participants | RECRUITMENT | Participants were adults 18 years or older residing in Australia who had received at least one primary dose of a COVID-19 vaccine but had not yet received a booster (third) dose and had access to the internet. Research company Quality Online Research (QOR) recruited a random sample of participants via email invitation from its accredited online panel. The QOR panel has >85,000 active members; original panel members were recruited via the Australia Post Lifestyle Survey, distributed to all Australian households. Ongoing recruitment is by invitation only. The panel reflects Australian Bureau of Statistics census data by age, gender, and state. Participants took part in the study via an online portal hosted by the research company and were offered points as incentive for participation equivalent to between AUD$1.00-$2.00, redeemable as payouts by PayPal, eGift cards or cheques. Participants gave written (digital) informed consent. Participants were recruited between 17–24 December 2021, with recruitment stopping when targets were met.For context, at the time of data collection, the Australian population had experienced multiple rounds of restrictions on movement, limits on indoor and outdoor gatherings, closure of restaurants, gyms and non-essential retail, and interstate and international border closures. Approximately two months prior to data collection (in October 2021), people living in the states of New South Wales and Victoria had exited strict and lengthy lockdowns in response to the Delta wave. In December 2021, domestic border closures had started to lift, however strict international border closures, put in place in March 2020 to prevent people from leaving and entering the country, were still in place at the time. In December 2021, Australia was anticipating the occurrence of a further Omicron wave, with cases rising rapidly [ | PMC10237633 | |
Pre-intervention survey items | After consenting, participants provided demographic information (age, gender, education, and state of residence). They were asked to respond to screening items about their COVID-19 vaccination status (‘Have you received a first/second/third dose of a COVID-19 vaccine?’, response options = yes/no). Participants were asked to indicate their hesitancy towards COVID-19 vaccines with a single item (‘How much do you agree with the following statement: “I feel hesitant about COVID-19 vaccines”‘, response options were on a 5-point scale from strongly disagree to strongly agree) informed by previous vaccination research [ | PMC10237633 | ||
Intervention | Participants received one of four intervention messages according to their randomised group. The intervention was a short piece of written material (a message of approximately 70–140 words) designed to encourage uptake of booster doses of COVID-19 vaccines. The material was modified from a public email communication campaign disseminated by an Australian health authority in November 2021. These modifications were made by the research team, based on the current state of evidence on the types of messages that may have an effect on intention to vaccinate. The control message informed recipients of eligibility requirements for a booster dose of COVID-19 vaccine. The four intervention messages added to this message, each using a different persuasive strategy. | PMC10237633 | ||
Intervention messages. | PMC10237633 | |||
Post-intervention outcome measures | Immediately after the intervention, participants responded to items measuring outcomes. The primary outcome measure was intention to receive a COVID-19 vaccine booster dose. This was assessed with a single item (‘How likely is it that you will get a booster dose of COVID-19 vaccine?’, with 5 response options: definitely, probably, I’m not sure, probably not, definitely not), consistent with survey questions used in previous research [Secondary outcome measures were beliefs about COVID-19 vaccine booster doses. These were assessed by asking participants to indicate their agreement with belief statements about COVID-19 vaccine booster dose safety, effectiveness, necessity for protecting one’s own health, necessity for protecting others’ health, and risks associated with not vaccinating (response options were a 5-point scale: strongly disagree, slightly disagree, neither agree nor disagree, slightly agree, strongly agree. See | PMC10237633 | ||
Sample size | The study aimed to recruit 480 participants to ensure a sample size of 430 participants, allowing for a drop-out/poor quality response rate of approximately 10%. The sample size was calculated using G*Power (an a priori power analysis tool) to estimate an effect size of Cohen’s d = 0.2 (the difference between two independent means) [ | PMC10237633 | ||
Randomisation | RECRUITMENT | Participants were randomly assigned at recruitment via a randomisation sequence embedded within the online system to receive one of the four intervention messages or the control message. Because some participants were excluded after randomisation (they either failed the attention check or did not complete the experiment, see | PMC10237633 | |
Flow diagram showing progress of participants through the online experiment. | PMC10237633 | |||
Statistical methods | The difference in proportion of participants intending to receive a COVID-19 vaccine and agreeing with COVID-19 vaccine booster dose belief statements was compared between the control group and each of the four intervention groups using tests of two proportions (z test). A subgroup analysis included data from vaccine hesitant participants only.Previous studies have shown that an effect size of ≥5 percentage points may have practical (clinical) significance [All analyses were conducted using SPSS (Statistical Package for Social Sciences, version 27). | PMC10237633 | ||
Role of the funding source | This research was funded by a grant from NSW Health. The sponsor had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. | PMC10237633 | ||
Results | Of the 487 participants who consented and were randomised, 442 (90.8%) completed the experiment, answered the attention check question correctly, and were included in the analysis. Participants had a mean age of 51.14 years ( | PMC10237633 | ||
Participant characteristics at baseline. | PMC10237633 | |||
Primary outcome (Intention to vaccinate) | Most participants (84.6%, 374/442) indicated a positive intention to get a booster dose of COVID-19 vaccine. | PMC10237633 | ||
Difference in intention to vaccinate in each intervention group compared to the control group. | PMC10237633 | |||
Difference in intention to vaccinate in each intervention group compared to the control group in hesitant participants (sub-analysis). | PMC10237633 | |||
Discussion | fatigue | WEDDINGS, INFLUENZA | This experiment found some evidence that messages emphasising non-health benefits of getting a COVID-19 booster dose, like travelling, enjoying family occasions like weddings, and seeing family and friends, may increase intention to vaccinate, especially in hesitant populations. In this study, intention was qualitatively higher in participants who viewed messages about non-health benefits compared to those who viewed messages about health benefits for themselves and the community. This is somewhat consistent with findings from an experiment in US adults [This study also found some evidence that messages emphasising benefits of COVID-19 vaccine booster doses to people’s personal health and the health of the community may increase intention to vaccinate. These findings are consistent with a systematic review of COVID-19 vaccine interventions [This study found that messages emphasising personal agency may have negative impacts, especially with hesitant individuals. This finding contrasts with previous findings, which suggest that individual liberty and a sense of personal agency when choosing vaccination may motivate people to vaccinate [Finally, in terms of COVID-19 vaccine booster dose beliefs, this study found more increased changes in beliefs in hesitant participants compared to the whole study population. This suggests that hesitant participants have beliefs that are possibly less fixed and more amenable to change, a result that has been found in studies about childhood vaccination [These have practical implications for communications from health authorities and other stakeholders to encourage uptake of COVID-19 booster doses, especially communications directed at individuals consuming vaccination information online. Health authorities should consider using a range of messages; an emphasis on non-health benefits may be particularly useful, although personal and community health benefits may also be effective. Any message should be pre-tested with target audiences; message effectiveness will depend on current circumstances and sentiment. Interventions specifically designed for and targeting hesitant, undecided populations are likely to bear the most fruit. For this population, messages emphasising personal agency should be used with caution. Until more evidence emerges, caution should also be taken with messages that leverage prescriptive norms that tell people how they ought to act (i.e., what the ‘right’ vaccination behaviour is). In all instances, messages should be tailored for specific communities, taking into account differences in factors affecting motivation to vaccinate and health literacy. Caution should be used when extrapolating this evidence for use with messages directed at individuals hesitant about other vaccines. Research with the community during the initial rollout of COVID-19 vaccines indicates the vaccines are perceived to be considerably different from other vaccines give their use of novel technologies (such as mRNA) and rapid development. Some individuals who report being accepting of most vaccines have indicated hesitancy in relation to COVID-19 vaccines [Future research could use qualitative methodologies to explore message development and testing to better understand the negative effects observed in this study. Research to better understand the effect of messages that leverage prescriptive norms would be useful. Exploring the effects of messaging on different age groups, as well as messaging that caters for varying literacy levels, would provide evidence to support development of more nuanced and targeted communications. Likewise, developing and testing different message formats beyond written information, such as videos and infographics, and channels beyond a static webpage would also be useful. Research focusing specifically on at-risk groups and hesitant populations would ensure greater vaccine equity and would provide useful insights into intervention effectiveness in key target populations. At-risk groups could include the elderly, pregnant women and people, people from different cultural or Indigenous communities, and people with disabilities. Several years into the COVID-19 pandemic, it would also be useful to understand ‘vaccine information fatigue’ (i.e., the extent to which communities have switched off from and appear immune to communication about COVID-19 vaccines), and how to continue encouraging uptake. This is particularly important if health authorities are to consider additional booster doses or an annual COVID-19 vaccine. Furthermore, given the overall high intentions found among the sample in this study, future research may need to shift the focus to interventions that translate intention into vaccination behaviour (i.e., people getting vaccinated). This could involve the use of behavioural nudges, such as text message reminders, which has shown some positive results early in the COVID-19 vaccination rollout, as well as with other vaccines such as influenza [This study has limitations. In this study, participants only saw the message once from a single source; multiple exposures from multiple sources over time may be required for long term changes to intention and behaviour to occur. This study did not measure changes in behaviour, but rather measured vaccination intention as an outcome. While in keeping with similar studies, behaviour in the form of vaccination uptake would provide a more accurate measure of the effectiveness of such interventions. Some of the intervention texts had a slight overlap. There was a clear emphasis on a single area of focus in each text via a bolded title and repetition of the particular benefit throughout the text. Future research, however, should use a manipulation check to verify that participants can identify the condition they are in, as well as checks to assess comprehension. The sample was highly educated, likely a result of the nature of the panel used. Online research panels in general are likely to represent people who are digitally literate and are willing and able to spend time responding to email invitations and surveys [ | PMC10237633 |
Conclusions | DISEASE | Health authorities should consider emphasising the broader benefits of vaccination beyond prevention of severe disease to encourage uptake of COVID-19 vaccine booster doses, as well as benefits to people’s personal health and the health of the community. Communication using personal agency should be used with caution. The findings of this research can inform future communication about booster doses of COVID-19 vaccines. | PMC10237633 | |
Supporting information | PMC10237633 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file. | PMC10237633 | ||
Supporting information. | (DOCX)Click here for additional data file. | PMC10237633 | ||
Protocol for persuasive COVID-19 vaccination message testing. | (DOCX)Click here for additional data file. | PMC10237633 | ||
Key Points | PMC9857635 | |||
Question | death, organ dysfunction | Does high-dose selenium therapy impact outcomes in patients at high risk of organ dysfunction and death after cardiac surgery? | PMC9857635 | |
Findings | In this randomized clinical trial of 1416 adult cardiac surgery patients, a high dose of sodium selenite compared with placebo did not result in a significant different morbidity or mortality. | PMC9857635 | ||
Meaning | death, organ dysfunction | High-dose sodium selenite was not effective in reducing the development of organ dysfunction and death in high-risk cardiac surgery patients. | PMC9857635 | |
Importance | Selenium contributes to antioxidative, anti-inflammatory, and immunomodulatory pathways, which may improve outcomes in patients at high risk of organ dysfunctions after cardiac surgery. | PMC9857635 | ||
Objective | postoperative organ dysfunction | To assess the ability of high-dose intravenous sodium selenite treatment to reduce postoperative organ dysfunction and mortality in cardiac surgery patients. | PMC9857635 | |
Design, Setting, and Participants | This multicenter, randomized, double-blind, placebo-controlled trial took place at 23 sites in Germany and Canada from January 2015 to January 2021. Adult cardiac surgery patients with a European System for Cardiac Operative Risk Evaluation II score–predicted mortality of 5% or more or planned combined surgical procedures were randomized. | PMC9857635 | ||
Interventions | Patients were randomly assigned (1:1) by a web-based system to receive either perioperative intravenous high-dose selenium supplementation of 2000 μg/L of sodium selenite prior to cardiopulmonary bypass, 2000 μg/L immediately postoperatively, and 1000 μg/L each day in intensive care for a maximum of 10 days or placebo. | PMC9857635 | ||
Main Outcomes and Measures | organ dysfunction | The primary end point was a composite of the numbers of days alive and free from organ dysfunction during the first 30 days following cardiac surgery. | PMC9857635 | |
Results | organ dysfunction | A total of 1416 adult cardiac surgery patients were analyzed (mean [SD] age, 68.2 [10.4] years; 1043 [74.8%] male). The median (IQR) predicted 30-day mortality by European System for Cardiac Operative Risk Evaluation II score was 8.7% (5.6%-14.9%), and most patients had combined coronary revascularization and valvular procedures. Selenium did not increase the number of persistent organ dysfunction–free and alive days over the first 30 postoperative days (median [IQR], 29 [28-30] vs 29 [28-30]; | PMC9857635 | |
Conclusions and Relevance | In high-risk cardiac surgery patients, perioperative administration of high-dose intravenous sodium selenite did not reduce morbidity or mortality. The present data do not support the routine perioperative use of selenium for patients undergoing cardiac surgery. | PMC9857635 | ||
Trial Registration | ClinicalTrials.gov Identifier: | PMC9857635 | ||
Introduction | organ dysfunction | Cardiac surgery is performed worldwide in an estimated 1 million patients per year.A potential way to reduce organ dysfunction is supplementation with the essential trace element selenium, which contributes to anti-inflammatory and immunomodulatory pathways and is a constituent of the active site of multiple antioxidant enzymes. | PMC9857635 | |
Methods | PMC9857635 | |||
Trial Design and Participants | congenital anomalies, arrest, cardiocirculatory arrest, neuropsychiatric disorders, hypersensitivity | HYPERSENSITIVITY, ARREST | We conducted an international, double-blind, randomized placebo-controlled trial, the Sodium Selenite Administration in Cardiac Surgery Trial (SUSTAIN CSX) trial, at 23 sites in Canada and Germany.Patients 18 years or older were eligible if they were scheduled to undergo elective or urgent cardiac surgery with the use of CPB and cardioplegic arrest and were at higher risk of perioperative morbidity and mortality as defined by the European System for Cardiac Operative Risk Evaluation (EuroSCORE) II predicted operative mortality of 5% or more or if combined surgical procedures were planned.Key exclusion criteria were hypersensitivity to sodium selenite or to any of the diluent vehicle, total bilirubin more than 2.0 mg/dL (to convert to micromoles per liter, multiply by 17.104), disabling neuropsychiatric disorders, pregnancy, lactation, current antioxidant use, cardiac transplant, planned ventricular assist device implantation, correction of complex congenital anomalies, or planned use of hypothermic cardiocirculatory arrest. The complete inclusion and exclusion criteria are noted in the trial protocol in | PMC9857635 |
Randomization and Masking | BLIND | The participants were randomly assigned in a 1:1 ratio to the intervention and placebo groups, respectively. Randomization was performed through a central, password-protected, web-based system with an audit trail that has been used for several prior international studies. Randomization was stratified by site in permuted blocks of size 4. The randomization list was prepared by the trial statistician (A.G.D.) who did not disclose the block size until after study enrollment was complete. Access to unblinded data was limited to the independent data monitoring committee until the trial database was completed and locked. Outcomes were not examined by treatment assignment until after the statistical analysis plan was finalized and published. To blind patients, investigators, and health care practitioners, selenium and placebo were prepared and supplied by an industry partner (Biosyn) in a way to maintain blinding. Selenium and placebo were provided similar in appearance, consistency, volume, and smell; study researchers were blinded to the treatment assignment at the time of enrollment to exclude selection bias. | PMC9857635 | |
Procedures | hospital-acquired infections, arrhythmias, Frailty, sternal wound infection, stroke/cerebral vascular accident | ARRHYTHMIAS, MYOCARDIAL INFARCTION, CARDIOVASCULAR COMPLICATIONS | According to the group allocation, patients either received 2000 μg/L (to convert to micromoles per liter, multiply by 0.0127) of intravenous selenium (sodium selenite; Selenase) within 30 minutes after induction of anesthesia and prior to initiation of CPB, then 2000 μg/L of intravenous selenium immediately on admission to the postoperative ICU, then 1000 μg/L of intravenous selenium each successive morning while in ICU or placebo at the same time points for a maximum of 10 days (eFigure 1 in In general, enrolled patients were followed up daily throughout the ICU stay. Baseline demographics (ie, age, sex, height, weight, diagnosis, EuroSCORE II, Sequential Organ Failure Assessment score, cardiovascular medication) and functional status (ie, Barthel Activity of Daily Living, Clinical Frailty Scale, Health Related Quality of Life with Short Form-36) were recorded before surgery. If possible, reevaluation of functional status was made 3 and 6 months after randomization. Moreover, data on surgical procedure and duration, perioperative hemodynamic profile (ie, heart rate, systemic and pulmonary blood pressure, central venous pressure, cardiac output), and laboratory measures (ie, complete blood cell count, international normalized ratio, blood lactate, creatinine) recorded postanesthetic induction, upon ICU admission, and at the first postoperative day were assessed. Additionally, the occurrence of surgical and cardiovascular complications (eg, myocardial infarction, arrhythmias, stroke/cerebral vascular accident, deep sternal wound infection) and hospital-acquired infections was monitored throughout the study period, while ICU and hospital length of stay were assessed at discharge. | PMC9857635 |
Outcome Measures | organ dysfunction | The primary outcome was the number of days alive and free of persistent organ dysfunction within the first 30 days after surgery. | PMC9857635 | |
Statistical Analysis | organ dysfunction | We estimated that a total sample size of 1400 participants followed up for 30 days would provide 90% power at a 2-sided α = .05 to detect a difference in persistent organ dysfunction–free days following selenium supplementation if the intervention caused a 20% relative increase in the daily rate of liberation from life-sustaining therapy but no change in mortality compared with the control arm. This effect size corresponded to a mean increase of 1.5 persistent organ dysfunction–free days (from 23.2 to 24.7 days). These estimates were based on 10 000 simulations where the control arm followed the distribution of a sample of 170 prior patients who met the current inclusion criteria.For the primary outcome, the van Elteren test stratified by site was used to calculate the | PMC9857635 | |
Results | PMC9857635 | |||
Participants | A total of 3791 patients were screened for eligibility; 1416 patients provided written consent and were randomized. Twenty-two randomized patients were excluded without ever receiving the allocated intervention; the majority of these were because the planned surgery was canceled or changed to a procedure not eligible per inclusion criteria. Thus, this primary modified intent-to-treat analysis includes 1394 patients with 697 in each treatment group ( | PMC9857635 | ||
Baseline Characteristics | The characteristics of patients at baseline were similar in the selenium and placebo group ( | PMC9857635 | ||
Baseline Demographics and Operative Characteristics | kidney disease | S; HEMOGLOBIN, KIDNEY DISEASE | Abbreviations: ACE, angiotensin-converting enzyme; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CABG, coronary artery bypass grafting; CBC, complete blood cell count; EF, ejection fraction; EuroSCORE, European System for Cardiac Operative Risk Evaluation; LVEF, left ventricular ejection fraction; WBC, white blood cell count.SI conversion factors: To convert albumin to grams per liter, multiply by 10; creatinine to micromoles per liter, multiply by 88.4; hemoglobin to grams per liter, multiply by 10; platelet count to ×10Moderate kidney disease is categorized as creatinine clearance of 0.6 to 1.0 mg/dL and severe kidney disease as creatinine clearance less than 0.6 mg/dL. There were no descriptively significant differences between the 2 groups.The present ethnicity list is used historically. Specific races and ethnicites in the other group were not reported. | PMC9857635 |
Compliance With Study Protocol | Only 228 doses of investigational product were missed of 7173 doses indicated by protocol, giving an overall compliance rate of 96.8%. There was no meaningful difference in compliance with dosing as per protocol between the selenium and placebo groups (eTable 1 in | PMC9857635 | ||
Trial Outcomes | death, organ dysfunction | The overall daily frequency of the components of persistent organ dysfunction and occurrence of death are shown in eTable 3 in | PMC9857635 | |
Primary and Secondary Outcomes | Delirium, Confusion | Abbreviations: HR, hazard ratio; ICU, intensive care unit; OR, odds ratio; WBC, white blood cell count.SI conversion factors: To convert albumin to grams per liter, multiply by 10; blood lactate to millimoles per liter, multiply by 0.111; creatinine to micromoles per liter, multiply by 88.4; creatine kinase–MB fraction to micrograms per liter, multiply by 1; platelet count to ×10Maximum Confusion Assessment Method for the ICU score and mean laboratory values were calculated over the treatment period for each patent before applying statistical summaries.Delirium tested by logistic generalized linear mixed-effects model with random site effect. Other outcomes tested by the van Elteren test stratified by site.Mean differences are reported.ORs are reported.HRs are reported. | PMC9857635 | |
Primary Outcome (Persistent Organ Dysfunction–Free Days in 30 Days) by Subgroups | CKD, chronic kidney disease, cardiac disorders | ADVERSE EVENTS, ADVERSE EVENT, CARDIAC DISORDERS | CKD indicates chronic kidney disease; EuroSCORE, European System for Cardiac Operative Risk Evaluation.The observed 30-day mortality rate was 4.2% (n = 29) in the selenium and 5.0% (n = 35) in the placebo group (odds ratio, 0.82; 95% CI, 0.50-1.36; The overall median (IQR) time to discharge alive from the ICU and hospital was 2.2 (1.1-5.1) days and 8.9 (6.2-14.9) days, respectively, with no statistically significant difference between groups for either measure (In total, 57 patients (8.2%) and 60 patients (8.6%) in the selenium and placebo groups had at least 1 serious adverse event, respectively. The most common class of serious adverse events was cardiac disorders occurring in 29 patients (4.2%) and 30 patients (4.3%) in the selenium and placebo groups, respectively (eTable 6 in | PMC9857635 |
Laboratory Subanalysis: Selenium, Selenoprotein, and Glutathione Peroxidase Levels | SEPARATION | The measurement of selenium blood levels in a subgroup of patients showed a clear separation of treatment groups and selenium levels were significantly higher in the treatment group over the observation period when compared with the placebo group ( | PMC9857635 | |
Perioperative Selenium Levels and Perioperative Activity of Glutathione Peroxidase 3 | SELENIUM DEFICIENCY | A, Perioperative selenium levels are compared by treatment and time points. The dotted lines indicate the reference range of selenium. Selenium concentrations below 70 μg/L indicate a selenium deficiency and selenium levels below 45.9 μg/L a severe selenium deficiency. | PMC9857635 | |
Discussion | myocardial injury, organ dysfunction | SECONDARY, MYOCARDIAL ISCHEMIA | In this rigorous, international trial of high-risk cardiac surgical patients undergoing complex procedures, high-dose selenium supplementation compared with placebo did not increase the number of days alive and without persistent organ dysfunction over the 30 days after cardiac surgery. No differences between groups were found for 30-day mortality, 6-month mortality, ICU length of stay, hospital readmission, daily rates of persistent organ dysfunction or frequencies of life-supportive therapies, or any other key secondary outcomes. Additional secondary outcomes demonstrated that fewer patients had a readmission to an ICU in the selenium group compared with the placebo group. Yet, these findings favoring high-dose selenium administration should be interpreted with caution and as hypothesis generating only as there was no adjustment made for multiple tests of significance and this finding could be a type I error.Observational studies demonstrate that myocardial ischemia, reperfusion time, and duration of CPB are associated with a decrease of intraoperative selenium levelsPreliminary evidence received from smaller studiesThere are several potential reasons for our neutral trial result, which differs from previous studies. Notably, our trial was the first and only multinational and multicenter study with an adequate sample size to determine if differences existed, to our knowledge. Studies with lower statistical power reporting significant treatment effects are less likely to be true positive and overestimate the size of the effect.Furthermore, recent innovations in surgical myocardial preservation techniques, such as combined antegrade and retrograde myocardial perfusion alone during bypass, are associated with smaller perioperative myocardial injury, which makes it challenging to demonstrate additional clinical benefits. | PMC9857635 |
Limitations and Strengths | POSTOPERATIVE COMPLICATIONS | One limitation of the trial is the use of the EuroSCORE II as part of the inclusion criteria to identify patients at increased risk for postoperative complications. The inaccuracy of the EuroSCORE II for cardiac surgery preoperative risk assessment is demonstrated in the discordance between the observed and predicted EuroSCORE II.A second limitation is that our population is predominantly male. Biosynthesis of selenoenzymes and selenoproteins is sex specific in a dose-dependent manner.The strengths of this study include its robust scientific methods and high-fidelity implementation, the randomized and blinded design, rigorous determination of selenium laboratory analyses, and intent-to-treat analysis, all of which augment the internal validity of the trial. The high rate of adherence to trial interventions, large number of patients, and enrollment in ICUs in Canada and Germany underline the high degree of precision and external validity. | PMC9857635 | |
Conclusions | postoperative organ dysfunctions | In conclusion, the results of our trial in high-risk cardiac surgery patients show that perioperative high-dose selenium administration is safe but did not impact postoperative organ dysfunctions or mortality following surgery (eFigure 3 in | PMC9857635 | |
References | Trial protocol and statistical analysis plan.Click here for additional data file.eMethods.eFigure 1. Intervention SchemeeFigure 2. Six-month Kaplan-Meier Survival CurveeFigure 3. Product-Limit Survival EstimateseAppendix. Supplemental Data to Figure 3A and 3BeTable 1. Compliance with Study Investigational ProducteTable 2. Protocol Violations and Concomitant Administration of Antioxidants or CorticosteroidseTable 3. Components of POD by DayeTable 4. Duration of PODs ComponentseTable 5. Hospital Acquired InfectionseTable 6. Serious Adverse EventseReferencesClick here for additional data file.Nonauthor Collaborators. The SUSTAIN CSX Study CollaboratorsClick here for additional data file.Data Sharing StatementClick here for additional data file. | PMC9857635 | ||
1. Introduction | obesity, metabolic inflexibility, HIT | OBESITY, INSULIN RESISTANCE, CARDIOVASCULAR DISEASES, TYPE II DIABETES | Women of childbearing age have variations in substrate oxidation rates that can lead to overweight, type II diabetes, and other conditions that may be associated with metabolic inflexibility and the variations in estrogen concentrations observed during the monthly ovarian cycle. Purpose: This study aimed to verify and compare the influence of eight treadmill high-intensity interval training (HIT) sessions on carbohydrate and lipid oxidation rates (CHOox and LIPox, respectively) and intensities of ventilatory anaerobic thresholds (VATs) of women in different phases of the monthly ovarian cycle. Methods: Eleven irregularly active women performed incremental treadmill exercise testing followed by submaximal work-rate running for 45 min to determine VATs, VOWomen of childbearing age, apparently healthy, may have a high propensity for changes in the oxidation of energy substrates (lipids and carbohydrates) and insulin resistance development, which, if not detected, can progress to type II diabetes, obesity, or other associated pathologies. This insulin resistance can occur due to metabolic inflexibility, the body’s inability to use energy substrates as fuel, and the transition between them in response to dietary change, energy availability, or circulating substrate concentrations [During the fertile period, women experience a monthly rhythm called the menstrual cycle. Each cycle lasts an average of 23 to 28 days and can be divided into follicular and luteal phases, in which hormonal fluctuations (estrogen and progesterone) occur. These hormones regulate reproductive function and other physiological systems, such as the respiratory, thermoregulatory, and cardiovascular systems, which can affect exercise performance. Most studies carried out with women prefer the follicular phase and close to ovulation, in which estrogen has its highest concentration. During this phase, more remarkable changes are noted in the oxidation rates of energy substrates, including increased availability of fatty acids, oxidative capacity, and suppression of protein catabolism, favoring better performance during exercise. On the other hand, in the luteal phase, high concentrations of progesterone are found, which has a physiological role during the menstrual cycle, exerting pituitary effects; in addition, the literature suggests that its high concentration affects the fertilization process [The literature has consistently shown that regular cardiorespiratory endurance training improves the performance of tasks that fundamentally depend on oxidative energy metabolism due to the increased ability of skeletal muscles to transport and utilize oxygen (OWhen analyzing the literature, it becomes noticeable that few studies with HIT or other training methods associate women’s energy metabolism in different phases of the menstrual cycle with possible modulation of metabolic flexibility and different impacts on health. Nevertheless, this combination is critical in preventing cardiovascular diseases [ | PMC9964010 |
2. Materials and Methods | PMC9964010 | |||
2.1. Trial Design, Setting and Ethics | This is a pre-post pilot study on the effects of the same intervention (exercise) in two groups (women at different stages of the menstrual cycle, called follicular and luteal; FL and LT, respectively), comparing pre-training with post-training variables. The study was not randomized and did not have a placebo or control group. The study was carried out at the Physical Education Research Laboratory of the University City of São Paulo, between August 2018 and December 2019, after approval by the Research Ethics Committee (CAEE: 31998914.8.0000.0064). All participants signed an informed consent form for inclusion in the study, anthropometric measurements, and intervention (physical training). | PMC9964010 | ||
2.2. Inclusion and Exclusion Criteria | We included in this study all women aged 18–35 years with a body mass index (BMI) of 18.5–24.9 kg/m | PMC9964010 | ||
2.3. Outcomes Evaluations | After the interview, clinical evaluation, and anthropometric measurements, the women were conveniently assigned to the follicular or luteal phase after entering the data in the Flo application. Then, they were tested to determine peak oxygen consumption (VO2peak), peak velocity (Vpeak), and ventilatory anaerobic thresholds (VATs: VAT1 and VAT2). Subsequently, they were submitted to running exercise at submaximal work pace for 45 min (SWRE) for indirect calorimetry, as described below, both tests in the same phase of the cycle identified initially. Subsequently, the women performed eight training sessions, with 48 h of recovery. At the end of the training period, the women had their data entered again in the Flo application, to identify whether they were in the same phase that they were initially evaluated, if they were, they performed the final tests for new determinations of the VAEs and performed another SWRE, the cases not were in the same phase of the initial exams, they waited until they were in the same phase, to be reassessed. Only the training sessions were not performed only in the corresponding menstrual cycle phase (Three physical education professionals were trained to carry out the assessments and reassessments. Each of them always performed the same procedure: anamnesis, anthropometric measurements, or body composition. The participants were blinded to the groups they belonged to, and so were the professionals who evaluated their data. | PMC9964010 | ||
2.4. Body Composition | fat-free mass, FM | DECUBITUS | Body composition was determined using a bioimpedance device (Bio-dynamics 310), according to the manufacturer’s instructions, to analyze body fat percentage (%BF), fat mass (FM), fat-free mass (FFM), and basal metabolic rate (BMR). The distance of 5 cm between the electrodes was respected, and the participant was positioned in dorsal decubitus with the right foot and hand slightly away from the trunk [ | PMC9964010 |
2.5. Cardiopulmonary Test | HEART | The test protocol consisted of running on a treadmill (Model ATL, Inbrasport Ltd., Porto Alegre, Brazil) with an initial speed of 6 km/h followed by increments of 1 km/h every minute until the participants’ voluntary exhaustion. Ventilatory parameters were collected throughout the tests at each respiratory cycle and analyzed at an average of 20 s using computerized gas analyzers (model VO2000; Inbrasport Ltd., Porto Alegre, Brazil). The gas analyzer was calibrated to standard volume and gas concentration immediately before the day’s first test and recalibrated after each one, according to the manufacturer’s standardization. Heart rate (HR) was continuously recorded using a heart monitor (Sport Test model; Polar Electro OY; Kempele, Finland) throughout the tests. The Borg subjective perception of exertion scale was used to help monitor the intensity of the test [ | PMC9964010 | |
2.6. Indirect Calorimetry (SWRE) | The balance of energy substrates was calculated by indirect calorimetry during submaximal work-rate running exercise for 45 min (SWRE), performed after six hours of fasting, before and after the training period. The dietary restriction before the SWRE session aimed to prevent the oxidation of exogenous carbohydrates among the participants during the experimental sessions [LIPox and CHOox rates were determined in 5-min blocks along the SWRE (5 to 40 min) from the VO | PMC9964010 | ||
2.7. Training Sessions | HIT | Participants performed eight HIT sessions, with a 48h interval between sessions. The treadmill HIT protocol consisted of two initial warm-up periods of 2 min each at 25% and 50% V | PMC9964010 | |
2.8. Statistical Analysis | The results are presented as the mean values ± standard error. The homogeneity and normality of the variables were verified using the Bartlett’s test and Shapiro–Wilk test, respectively. When appropriate, participants’ characteristics, ventilatory parameters, HR, and running speed were compared using Student’s The substrate oxidation rates of pre- and post-training according to the monthly sexual cycle phases were analyzed using multiple comparisons by Kruskal–Wallis test. The significance level adopted was | PMC9964010 | ||
3. Results | Initially, the anthropometry and body fat percentage (%BF) of 19 women were evaluated, of which 16 had BMI and %BF according to the inclusion criteria. Among these, eight were directed to the follicular group (FL) and eight to the luteal group (LT). Participants were allocated according to their menstrual cycle phase, on the day of the first indirect calorimetry assessment, after analyzing the data entered in the Flo application (1st to 14th day: follicular group/15th to 28th day: group luteal). Later on, two participants from the FG and three from the GL dropped out. The flow of participants is shown in | PMC9964010 | ||
3.1. Characterization of Participants | Anthropometric, body composition, resting blood glucose, and ventilatory data are presented in | PMC9964010 | ||
3.2. Max Tests and Exercise Intensity | The absolute mean values of peak effort and VATs for VOThe VAT means values relative to peak effort for VO | PMC9964010 | ||
3.3. Training Sessions | During training sessions, V | PMC9964010 | ||
3.4. Oxidation of Substrates | The indirect calorimetry data are presented in The relative energy derived from CHO after the training period was 18.89% higher in the FL group and 25.50% higher in the LT group. Consequently, the relative energy derived from LIP after training was 8.45% and 3.46% lower in FL and LT groups, respectively ( | PMC9964010 | ||
4. Discussion | incongruity, HIT | Our purpose was to examine the substrate oxidation rates of reproductive-age eumenorrheic women by indirect calorimetry during SWRE at two hormonally distinctive menstrual cycle phases, pre- and post-HIT. The present substrate metabolism finding indicated a greater dependency upon lipid versus carbohydrate in the menstrual cycle luteal phase compared to the follicular phase in pre-intervention. This finding agrees with other studies that measured exercise RER at the low and moderate intensities of maximal oxygen consumption (VOHackney et al. reported greater LT lipid oxidation only when exercise was performed at 35–60% of the VODuring FL there is a high concentration of 17β-estradiol, progressive increase of estrogen, and absence of progesterone, which favors the absorption of glucose by the muscle and its oxidation, reducing LIPox and protein oxidation [When the reactions of these hormones to different exercise intensities were studied, variations in substrate oxidation rates were mentioned, in which low rates of CHOox and high rates of LIPox were found in the LT in low and moderate-intensity exercises [In contrast, other studies have found greater carbohydrate oxidation and lower lipid oxidation in LT compared to FL during the menstrual cycle with exercise intensity of 45% [For Vaiksaar et al. [The present study’s results show that eight HIT sessions promoted beneficial effects for other parameters, such as Vpeak in FL. Data that corroborate those presented by Gibala et al. [According to Aparecido et al. [The comparison between groups showed significant differences in relative energy derived from CHOox pre- and post-training of −61.4% and −59.3%, respectively, and LIPox pre- and post-training of 27.5% and 34.4%, respectively. The relative energy derived from CHOox after the training period was 18.9% and 25.5% higher for FPG and LPG, respectively; consequently, the relative energy derived from LIPox after the training period was 8,45% and 3.46% lower for FL and LT, respectively. The greater sensitivity of alpha- and beta-adrenergic receptors, with increased glucose uptake, greater glycolytic enzyme activation, and modulation of substrate oxidation due to moderate-to-high strength or resistance exercise can explain this phenomenon [This discrepancy in the results of the studies reinforces that the impact of HIT on women of reproductive age is still controversial. This incongruity can be justified by the wide variety of HIT protocols applied or even by the inherent characteristics of the female sex—totally ignored in the methodology and discussion of the studies selected [Studies have demonstrated that estrogen has a direct and indirect (via growth hormone [GH] and cortisol) lipolytic action on adipose tissue. Several studies have reported elevated resting and exercise levels of GH in women during the LT. However, it was recently reported that there is no enhanced GH response to exercise in the LT compared to the FL. Data from the same study also showed increased cortisol during exercise in the LT but no increase during the FL [At this point, it seems important to investigate women’s hormonal status and physiological exercise-induced responses to clarify specific hormonal and metabolic responses leading to specific fuel selection. Moreover, cellular studies must consider the complex inherent mechanisms of such adaptations.The novelty of the current study was that the oxidation substrate post-HIT ratio and the female characteristics had not been previously investigated and/or discussed in women of reproductive age. Thus, further research is needed to test the potential superiority of HIT vs. moderate-intensity continuous training (MICT) on body composition and general oxidative metabolism. Moreover, it will be vital to elucidate whether hormonal changes in the female ovarian cycle or the use of different types of contraceptives (estrogen and progesterone) could induce a state of both metabolic “flexibility or inflexibility” effects in this population under different protocols of HIT training.Our current data, although showing extreme values, probably due to the small sample size, suggest an important relationship between the training model adopted and the adaptations promoted on the oxidation capacity of CHO and LIP throughout the monthly sexual cycle. Undoubtedly, this is an important limitation of this study, which is why we classify it as a preliminary or pilot study. | PMC9964010 | |
5. Conclusions | The phases of the menstrual cycle promote significant changes in substrate oxidation rates, leading to a decrease in CHOox and an increase in LIPox in the follicular phase, possibly due to the higher concentration of estrogen, which favors changes in metabolism and performance during submaximal work rate exercise. High-intensity interval training can minimize the observed differences and constitute an alternative intervention. | PMC9964010 | ||
Author Contributions | Individual author contributions are as follows: conceptualization, C.S.F.; methodology, C.S.F., M.L.M. and J.M.L.A.; software, M.L.M.; formal analysis, M.L.M.; investigation, C.S.F., J.M.L.A. and M.S.C.; data curation, M.L.M.; writing—preparation of original draft, C.S.F.; writing—proofreading and editing, C.S.F., M.L.M., J.M.L.A., P.S.R. and A.H.L.J.; supervision, M.L.M. and A.H.L.J.; project management, C.S.F.; translation, M.L.M. and P.S.R. All authors have read and agreed to the published version of the manuscript. | PMC9964010 | ||
Institutional Review Board Statement | The study was conducted and approved by the Institutional Review Board of University City of Sao Paulo (UNICID), n° (31998914.8.0000.0064) for studies involving humans. | PMC9964010 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. Written informed consent has been obtained from the patient(s) to publish this paper. | PMC9964010 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy. | PMC9964010 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9964010 | ||
Abbreviations | PMC9964010 | |||
References | ± | Intervention.Flowchart of the inclusion, allocation, and follow-up process of the 11 study participants. Follicular (FL) and luteal (LT) groups.Relative energy derived from carbohydrates (CHOkc) and lipids (LIPkc) pre- and post-training. Mean values ± standard error; follicular (FL, Baseline data of groups follicular (FL) and luteal (LT).Mean values ± standard error. No significant differences were found.Absolute mean values of peak effort and VATs.Mean values ± standard error. VAT1: first ventilatory threshold; VAT2: second ventilatory threshold; VOVentilatory anaerobic thresholds means values relative to peak effort.Mean values ± standard error. VAT1: first ventilatory threshold; VAT2: second ventilatory threshold; O2: oxygen consumption; HR: heart rate; VEL: velocity. No significant differences were found.Mean relative intensities of training sessions.Mean values ± standard error. O2, oxygen consumption; HR, heart rate. Indirect calorimetry data.Mean values ± standard error. TTkc: total caloric expenditure; CHOkc: relative amount of energy derived from CHO oxidized; LIPkc: relative amount of energy derived from LIP oxidized. Relative substrate oxidation differences between training periods and menstrual cycle phases.Mean values ± standard error. CHOkc: relative amount of energy derived from CHO oxidized; LIPkc: relative amount of energy derived from LIP oxidized. | PMC9964010 |
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