title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Key Outcomes | PMC10034662 | |||
Diagnostic Status | The CIS-R | PMC10034662 | ||
Primary Outcome | Depression | Depression symptom severity (PHQ-9) | PMC10034662 | |
Safety | ADVERSE EVENTS | Serious adverse events were recorded in line with Health Research Authority (England) guidelines and judged by an independent monitor as study related or study unrelated. An adapted version of the Lasting Negative Effects Questionnaire was completed at 42 weeks. | PMC10034662 | |
Health Economic Evaluation | Health-related quality of life was assessed at baseline, 16 weeks, and 42 weeks using the recently developed 5-level version EuroQoL (EQ-5D-5L) to maximize sensitivity. | PMC10034662 | ||
Secondary Outcomes | anxiety | Generalized anxiety, well-being, functioning, and mindfulness were measured at baseline, 16 weeks and 42 weeks. See the eMethods in | PMC10034662 | |
Procedure | depression | HOLIDAYS | Referrals were from the IAPT program. People experiencing depression were also invited through general practitioners and social media to self-refer to IAPT and, if eligible for self-help treatment in IAPT, were assessed for eligibility. Potential participants had a copy of the participant information sheet and the oppo... | PMC10034662 |
Randomization and Masking | Participants were randomly assigned using Sealed Envelope | PMC10034662 | ||
Supervision and Monitoring | In IAPT, PWPs are graduates (in any discipline) who complete a year-long CBT-SH training. The 69 study PWPs received training to support MBCT-SH for this study. Training in the study involved qualified PWPs completing an MBCT course in person or using the workbook and then attending a 2-day MBCT-SH training. As is stan... | PMC10034662 | ||
Lived-Experience Involvement | depression | RECRUITMENT | People with lived experience of depression and of CBT and mindfulness were involved in study development. This included contributing to the project proposal, recruitment materials, and qualitative data collection and analysis. A Lived Experience Advisory Panel of 6 members was led by the lived experience coapplicant wh... | PMC10034662 |
Statistical Analysis | The study was powered to detect a between-group standardized effect of 0.36 at 16 weeks on the primary outcome. This was based on the difference between the reported between-group effect of CBT-SH (0.42) | PMC10034662 | ||
Clinical Outcomes | depressive | REGRESSION | The primary analysis of clinical outcomes was an intention-to-treat (ITT) between-group comparison of MBCT-SH to CBT-SH at 16 weeks and 42 weeks using a linear mixed model with treatment group, time (16 weeks or 42 weeks), and a treatment group × time interaction as fixed factors and site and baseline PHQ-9 score as co... | PMC10034662 |
Health Economic Analysis | The UK National Health Service or personal social services perspective preferred by the National Institute for Health and Care ExcellenceCost-effectiveness was assessed through the calculation of incremental cost-effectiveness ratios explored in terms of quality-adjusted life-years (QALYs) calculated from the EQ-5D-5L. | PMC10034662 | ||
Results | In total, 600 people were assessed for eligibility. Of 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. Of the 410 participants, 204 were allocated to MBCT-SH and 206 to CBT-SH between November 24, 2017, and January 31, 2020, with final follow-up on December 15, 2020.... | PMC10034662 | ||
CONSORT Trial Profile | CBT-SH indicates cognitive behavioral therapy self-help; CIS-R, Clinical Interview Schedule–Revised; IAPT, Improving Access to Psychological Therapies; ITT, intention to treat; MBCT-SH, mindfulness-based cognitive therapy self-help; PHQ-9, Patient Health Questionnaire. | PMC10034662 | ||
Mean Costs per Participant Between Baseline and 42-Week Follow-up | Abbreviations: NA, not applicable; QALYs, quality-adjusted life years.Adjusted by baseline variable of interest plus baseline utility, baseline PHQ-9, site, and follow-up time.Cost-effectiveness analysis found MBCT-SH dominated CBT-SH—it generated better outcomes for lower cost. | PMC10034662 | ||
Cost-Effectiveness Acceptability Curve for Mindfulness-Based Cognitive Therapy Self-help (MBCT-SH) vs Cognitive Behavioral Therapy Self-help at 42 Weeks Postrandomization | QALY indicates quality-adjusted life-year. | PMC10034662 | ||
Discussion | depressive, depression, anxiety, CBT-SH | ADVERSE EVENTS, SECONDARY, BLIND | The primary hypothesis was supported: practitioner-supported MBCT-SH was superior to practitioner-supported CBT-SH in reducing depressive symptom severity at postintervention follow-up. In addition, PWP-supported MBCT-SH was found to be cost-effective compared with PWP-supported CBT-SH due to significantly lower total ... | PMC10034662 |
Limitations | This study has limitations. Confidence in findings is limited by study dropout. However, this concern is partially mitigated by similar rates of study dropout across arms (eResults and eTables 1 and 2 in | PMC10034662 | ||
Conclusions | depressive, depression | In conclusion, this study found that a novel intervention, practitioner-supported MBCT-SH, was clinically superior in targeting depressive symptom severity at postintervention and cost-effective compared with the criterion standard of practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Th... | PMC10034662 | |
Background | We compared Fakhravac and BBIBP-Corv2 vaccines in a phase III trial. | PMC10355035 | ||
Method | DISEASE, RECRUITMENT | We conducted a multicenter, parallel-group, active-control, non-inferiority clinical trial with pragmatic considerations assessing the safety and efficacy of Fakhravac and BBIBP-Corv2 vaccines. We started with two randomized double-blind arms and added two non-randomized open-label arms (based on participant preference... | PMC10355035 | |
Result | ADVERSE REACTIONS, ADVERSE EVENT, EVENTS | We enrolled 24,056 adults in four groups (randomized-Fakhravac: 824, randomized-BBIBP-Corv2: 832; Non-randomized-Fakhravac: 19,429, Non-randomized-BBIBP-Corv2: 2971). All observed local and systemic adverse reactions were generally self-limited and resolved completely. We observed similar Serious Adverse Event (SAE) ra... | PMC10355035 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12985-023-02121-z. | PMC10355035 | ||
Keywords | PMC10355035 | |||
Background | VIRUS | Fakhravac is an inactivated SARS-CoV-2 vaccine based on the SARS-CoV-2 IR-sb2-01 strain cultured in a Vero cell line. The IR-sb2-01 strain was isolated from hospitalized patients who had severe clinical illnesses. The virus was inactivated by formaldehyde and emulsified with aluminum hydroxide adjuvant to formulate the... | PMC10355035 | |
Method | PMC10355035 | |||
Study design | RECRUITMENT | We conducted a multicenter, parallel-group, active-control, non-inferiority clinical trial with pragmatic considerations comparing the safety and efficacy of Fakhravac and BBIBP-Corv2 vaccines. It started with two randomized and double-blind arms. We added two additional non-randomized and open-label arms of Fakhravac ... | PMC10355035 | |
Participants | alcohol abuse, angioedema, allergic diseases | ACUTE FEBRILE ILLNESS, ANGIOEDEMA, ANAPHYLACTIC REACTION, CHRONIC DISEASES | Volunteer enrollment was managed via the study web-based software. They could read the informed consent and go through an initial self-administered screening questionnaire. Those who passed this stage were invited to attend the clinical trial centers for face-to-face screening by the study officers and signing the writ... | PMC10355035 |
Randomization and masking | The study epidemiologist created the random allocation sequence to assign the participants to the BBIBP-CorV or Fakhravac vaccine groups (in a 1:1 ratio) in the randomized arms using a variable-sized (4 and 6) block randomization method. Stata software was used for this purpose. We concealed the random allocation seque... | PMC10355035 | ||
Procedures | redness, myalgia, Accidents, diarrhea, swelling, fatigue, pain, headache, tenderness | ADVERSE REACTIONS, ADVERSE EVENT, EMERGENCY | We monitored immediate reactions and vital signs following vaccine injections for half an hour at the clinical trial centers. All collected information was recorded in the web-based study software.We asked the participants to report their daily local (pain, tenderness, swelling, and redness) and systemic (nausea/vomiti... | PMC10355035 |
Outcomes | sore throat, anaphylaxis, myalgia, death, fever, diarrhea, shock, respiratory failure, neurologic dysfunction, cough, anosmia, hyposmia, headache, chills, shortness of breath | SORE THROAT, ADVERSE REACTIONS, ANAPHYLAXIS, ADVERSE EVENT, SARS-COV-2 INFECTION, SHOCK, RESPIRATORY FAILURE, DISEASE, SECONDARY, ADVERSE REACTION, ACUTE RESPIRATORY DISTRESS SYNDROME | The primary outcome was the occurrence of PCR-positive symptomatic Covid-19 disease 14 days or more after the second injection. A SARS-CoV-2 RT-PCR test was requested for all participants with clinical symptoms suspicious of SARS-CoV-2 infection, including fever (temperature ≥ 38 °C), chills, cough, shortness of breath... | PMC10355035 |
Statistical analysis | infectious disease | EVENTS, DISEASE, INFECTIOUS DISEASE | We needed 365 events of the primary outcome to demonstrate the non-inferiority of Fakhravac based on a 10% non-inferiority margin of the reported 72.8% efficacy of BBIBP-Corv-2 [We used frequencies (percentages) for categorical variables and mean (SD) for continuous variables to compare baseline values in the study gro... | PMC10355035 |
Role of the funding source | The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. | PMC10355035 | ||
Discussion | SAEs, cardiovascular deaths | ADVERSE REACTIONS, EVENTS, RECRUITMENT, RECRUITMENT | We found that the Fakhravac inactivated SARS-CoV-2 vaccine is similar in safety and efficacy to the BBIBP-Corv2 vaccine. All observed local and systemic adverse reactions were generally self-limited and resolved completely. We observed a slightly higher occurrence of solicited local and systemic adverse reactions and a... | PMC10355035 |
Limitation | CHRONIC DISEASES, BLINDNESS | First of all, the study was initially designed as an RCT, but due to the dissatisfaction of the volunteers with the blindness and randomness of the study, the study design was changed to a comprehensive cohort study. Second, the study did not include pregnant women or those younger than 18 years; thus, the efficacy and... | PMC10355035 | |
Conclusion | Covid19 | DISEASE | Fakhravac vaccine is safe and effective as the Sinopharm vaccine in preventing symptomatic PCR-positive covid-19 disease. In another way, we could prove the non-inferiority of Fakhravac to the BBIBP-Corv2 vaccine. However, the Fakhravac vaccine is significantly more effective than the Sinopharm vaccine in preventing ho... | PMC10355035 |
Acknowledgements | This work was supported by the Milad Daro Noor Pharmaceutical (MDNP) Company. The immunology lab and all other research staff involved in collecting and examining blood samples taken for immunogenicity assessment were masked to the identity of the participants and the allocated interventions. The study was overseen by ... | PMC10355035 | ||
Author contributions | MP, FGN | Conceptualization: PB, MSD, and MF. Data Curation: AS, and KG. Formal Analysis: AS, and KG. Investigation: MSD, PB, MM, MA, AS, KG, SG, AS, MP, AM, MH, SK, FG, ZR, FGN. Methodology: MSD, RHF, and MF. Project Administration: MSD, AKR, and KN. Validation: MSD, AA, AS, KG, MA, FG, and ZR. Visualization: MSD, AS, and KG. W... | PMC10355035 | |
Funding | Milad Daro Noor Pharmaceutical (MDNP) Company provided the funding for this study and the logistics for study conduct but had no role in data management, analysis, interpretation, or writing the report. The Grant number of this study is Not Applicable. | PMC10355035 | ||
Availability of data and materials | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10355035 | ||
Declarations | PMC10355035 | |||
Ethics approval and consent to participate | The clinical trial protocol was approved by the Iranian National Ethics Committee for research (approval number IR. NREC.1400.006, 31st August 2021). | PMC10355035 | ||
Consent for publication | Not applicable. | PMC10355035 | ||
Competing interests | MH | ASH | AKR, SG, AS, AM, MH, and SK are employees of Milad Daro Noor Pharmaceutical (MDNP). MSD is an Iran University of Medical Science (IUMS) employee. MSD, PB, AA, MA, ASH, ZR, FGH, and KG are members of the clinical trial center of the Iran University of Medical Science that acted as academic CRO. All other authors declare... | PMC10355035 |
References | PMC10355035 | |||
Background | Ketamine is administered in the perioperative period for its benefits in analgesia, anti-agitation and anti-depression when administered at a small dose. However, it is not clear whether the intra-operative administration of ketamine would affect emergence under sevoflurane anesthesia. To investigate this effect, we de... | PMC10288804 | ||
Methods | delirium, postoperative agitation | In this randomized, double-blind, placebo-controlled study, we enrolled 44 female patients aged 18–60 who were scheduled to elective laparoscopic gynecological surgeries. All patients were randomly assigned to saline or s-ketamine group. In s-ketamine group, patients received 0.125 mg/kg s-ketamine 30 min after the sta... | PMC10288804 | |
Results | There were no significant differences in emergence time between s-ketamine group and saline group (10.80 ± 3.77 min vs. 10.00 ± 2.78 min, | PMC10288804 | ||
Conclusion | Ketamine administered during sevoflurane anesthesia had no apparent influence on emergence time in young and middle-aged female patients undergoing laparoscopic surgery. Subanesthetic s-ketamine induced an active prefrontal EEG pattern during sevoflurane anesthesia but did not raise neurological side effects after surg... | PMC10288804 | ||
Trial registration | Chinese Clinical Trial Registry, ChiCTR2100046479 (date: 16/05/2021). | PMC10288804 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12871-023-02170-5. | PMC10288804 | ||
Keywords | PMC10288804 | |||
Background | Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, was initiated to be used clinically for anesthetic induction and maintenance in the 1970s [Theoretically, the co-administration of subanesthetic ketamine during general anesthesia could deepen the anesthetic depth. A series of studies have confirmed that low... | PMC10288804 | ||
Methods | MAY | This prospective, randomized, controlled, double-blind trial was registered in the Chinese Clinical Trial Registry (chictr.org.cn) (ChiCTR2100046479, date: 16/05/2021). Ethical approval for this study (NO. KY20202065-X-1, date: 07/04/2021) was provided by the Medical Ethics Committee of the First Affiliated Hospital of... | PMC10288804 | |
Study population | abnormal cognitive function, psychiatric disorders | NEUROLOGICAL DISEASE | Han Chinese patients aged 18–60 years old with an American Society of Anesthesiologists (ASA) physical status of I–II who were scheduled for elective laparoscopic gynecological surgery and signed the informed consent voluntarily were eligible for inclusion in this study. Patients with a history of psychiatric disorders... | PMC10288804 |
Randomization and blinding | The simple randomization was chosen in our trial which was performed using an online randomization list to ensure that each group contained 22 subjects. The subjects were randomly assigned 1:1 to either the saline group or the s-ketamine group. The randomization envelopes contained grouping information. The nurses who ... | PMC10288804 | ||
Anesthesia and monitoring | Dexmedetomidine, midazolam, and anticholinergic drugs were not permitted before surgery. Vital signs such as pulse oximetry, blood pressure (BP), and electrocardiography were monitored as soon as the patients arrived in the operating room. A Chinese brand of anesthesia depth monitor based on EEG, ConView system (ConVie... | PMC10288804 | ||
Outcome measures | delirium, agitation, Delirium, Confusion | The primary outcome was emergence time, which was defined as the interval between the cessation of sevoflurane and the point at which the patient opened their eyes. During this recovery period, we aroused the subjects by calling their names every 30 s until they responded by opening their eyes.Secondary outcomes includ... | PMC10288804 | |
Spectral processing | EEG data were obtained at a sampling rate of 500 Hz by using ConView. The ConView system is designed by Pearlcare Medical Technology Company Limited (Zhejiang, China), based on three different parameters of EEG: sample entropy (SampEn), 95% spectral edge frequency (SEF) and burst suppression ratio (BSR). The new anesth... | PMC10288804 | ||
Statistical analysis | SD | SECONDARY | The sample size was calculated based on the time of emergence. According to the results of our previous study, the emergence time was 7.7 min with a standard deviation (SD) of 1.2. In our pilot trial, we found that the administration of subanesthetic s-ketamine could reduce the emergence time by 10.6%. Then, we hypothe... | PMC10288804 |
Primary outcome | The time from the cessation of sevoflurane administration to the emergence of patients in the s-ketamine group was not significantly different from that in the saline group (saline: 10.80 ± 3.77 min vs. s-ketamine: 10.00 ± 2.78 min, | PMC10288804 | ||
Secondary outcomes | PMC10288804 | |||
Prefrontal EEG spectra | To evaluate the intra-operative effect of subanesthetic s-ketamine, we exhibited the full-range EEG median spectrograms of saline and s-ketamine groups (Fig. Spectral analysis of EEG signals before and after the administration of s-ketamine. During the recovery period after the cessation of sevoflurane, the power and p... | PMC10288804 | ||
Discussion | delirium, agitation | In this randomized controlled study, we observed the effects of a bolus of subanesthetic s-ketamine administered during elective laparoscopic gynecological surgery on emergence time in the female patients. We did not find a difference in the time duration from cessation of anesthetics to eye opening between the s-ketam... | PMC10288804 | |
Conclusion | In conclusion, intra-operative administration of subanesthetic s-ketamine did not change the emergence time of young and middle-aged women undergoing elective laparoscopic gynecological surgery. The administration of s-ketamine can induce active EEG during sevoflurane anesthesia but did not have negative effects on neu... | PMC10288804 | ||
Acknowledgements | Not applicable. | PMC10288804 | ||
Authors’ contributions | Study design and supervision: Qianzi Yang and Hailong Dong. Project administration and randomization: Ao Li, Tingting Liu, Xue Yang. Generating the random allocation sequence: Ao Li. Preparing s-ketamine or saline: Huanhuan Zhang. Data collection: Tiantian Liu. Anesthesiologist: Yanling Lei. Data analysis: Tiantian Liu... | PMC10288804 | ||
Funding | This study was supported by the National Natural Science Foundation of China (Grant No. 82071554 to Qianzi Yang and No. 82030038 to Hailong Dong). | PMC10288804 | ||
Availability of data and materials | The datasets generated during the current study are not publicly available due ethical concerns but are available from the corresponding author on reasonable request. | PMC10288804 | ||
Declarations | PMC10288804 | |||
Ethics approval and consent to participate | Ethical approval for this clinical study (NO. KY20202065-X-1) was provided by the Medical Ethics Committee of the First Affiliated Hospital of the Fourth Military Medical University on 7 April 2021. All participants or their legal representatives provided written informed consent before enrollment. The trial was regist... | PMC10288804 | ||
Consent for publication | Not applicable. | PMC10288804 | ||
Competing interests | The authors declare no competing interests. | PMC10288804 | ||
References | PMC10288804 | |||
Background | intradialytic exercise, kidney failure | KIDNEY FAILURE | Patients with kidney failure experience derangements of circulating markers of mineral metabolism and dysregulation of skeletal and cardiovascular physiology which results in high mortality rate in these patients. This study aimed to evaluate the effect of intradialytic exercise on regulation of these abnormalities in ... | PMC10512624 |
Methods | In this randomized controlled trial conducted in an HD center in Iran, adult patients receiving chronic HD were randomized to intradialytic exercise (60 min) in the second hour of thrice weekly dialysis for 6 months (intervention) or no intradialytic exercise (control). The primary outcomes were serum calcium, serum ph... | PMC10512624 | ||
Results | The study included 44 participants randomized to intervention ( | PMC10512624 | ||
Conclusion | Intradialytic, bone mineral disorders, HD | Intradialytic exercise performed for at least 60 min during thrice weekly dialysis sessions improves bone mineral metabolism in adult patients receiving HD. Further studies should focus on observing and comparing the effect of different types of exercise on bone mineral disorders and all-cause mortality in HD patients. | PMC10512624 | |
Trial registration | Intradialytic | PARATHYROID | ClinicalTrials.gov Identifier: NCT04916743, Registered on 08/06/2021. Registered trial name: The Effect of Intradialytic Exercise on Calcium, Phosphorous and Parathyroid Hormone: A Randomized Controlled Trial. | PMC10512624 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12882-023-03327-7. | PMC10512624 | ||
Keywords | PMC10512624 | |||
Background | muscle atrophy, disordered muscle protein, ESKD, CVD, anemia, PD, hyperphosphatemia, malnutrition, hypocalcemia | MUSCLE ATROPHY, CVD, KIDNEY REPLACEMENT, HYPERPARATHYROIDISM, ANEMIA, HYPERPHOSPHATEMIA, SECONDARY HYPERPARATHYROIDISM, MALNUTRITION, END STAGE KIDNEY DISEASE, HYPOCALCEMIA, CARDIOVASCULAR DISORDERS | In recent years, there has been a rapid increase in the prevalence of patients with end stage kidney disease (ESKD) that require kidney replacement therapy, including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplant [The primary etiological factors responsible for these outcomes include cardiovascular d... | PMC10512624 |
Methods | PMC10512624 | |||
Trial design | RECRUITMENT | This study is an open-label, parallel arm, randomized controlled trial with blinded end-points, which was conducted in a medical center in Iran. Recruitment occurred between July 25, 2021 and 10 August 2021. | PMC10512624 | |
Participants | cardiac instability, myocardial infarction, angina, decompensated congestive heart failure, arteriovenous stenosis, musculoskeletal pain, hyperglycemia, infection, arrhythmias, lower extremity amputation, shortness of breath | MYOCARDIAL INFARCTION, HEMODYNAMIC INSTABILITY, HYPERGLYCEMIA, INFECTION, HYPOGLYCEMIA, ARRHYTHMIAS | Individuals were eligible to participate in the study after meeting all of the following inclusion criteria: 1) age ≥ 18 years; 2) receiving regular HD 3 times a week; 3) on HD for at least 1 year, 4) absence of a history of myocardial infarction within the past 3 months; 5) permission from their physician to participa... | PMC10512624 |
Trial procedures | comorbidity, cardiac diseases, cancer, diabetes, dysrhythmia, intradialytic, cerebrovascular accident/transient | CARDIAC DISEASES, ATHEROSCLEROTIC HEART DISEASE, CANCER, GASTROINTESTINAL BLEEDING, LIVER DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ISCHEMIC ATTACK, DYSRHYTHMIA, CONGESTIVE HEART FAILURE, KIDNEY FAILURE, PERIPHERAL VASCULAR DISEASE, DIABETES | Before starting the study, some educational and motivational posters were installed in the dialysis center so that all patients became familiar with the benefits of exercise and especially intradialytic exercise. Then, the principal investigator described the side-effects of inactivity and sedentary lifestyle to all in... | PMC10512624 |
Intervention | AV fistula, fistula, shoulder horizontal abduction | Subjects in the intervention group performed concurrent intradialytic exercise during the 2nd hour of dialysis (60-min exercise sessions three times a week) for 6 months. The intervention was a combination of aerobic and resistance exercises. Workout time at the beginning was 30 min and gradually increased to 60 min. E... | PMC10512624 | |
Blood sampling | Baseline blood samples were collected one day before the start of the exercise session. Exercise began at the mid-week dialysis session. After the end of the 36th session (end of the third month) and after the end of the 72nd session (end of the sixth month), subsequent blood samples were collected the day before the m... | PMC10512624 | ||
Outcomes | ADVERSE EVENTS | The primary outcome measures included changes in serum calcium (mg/dL), serum phosphorous (mEq/L) and parathyroid hormone (pg/mL) over time. Rate of changes of alkaline phosphatase (ALP) (U/L) and calcium-phosphorous product (mgSafety outcomes included all serious adverse events and adverse events. | PMC10512624 | |
Adherence | Intervention adherence was defined as the number of sessions performed divided by the number of sessions offered, multiplied by 100. | PMC10512624 | ||
Blinding | BLIND | Due to the nature of the intervention, it was not feasible to blind participants or study staff.However, outcome assessors and data analysts were blinded to participants’ treatment allocations. | PMC10512624 | |
Sample size | The sample size was calculated in accordance with a previous study [Assuming an effect size of 0.45 for reduction of PTH and a drop-out rate of 20%, 44 participants (22 per group) were required to provide 80% power. | PMC10512624 | ||
Statistical analysis | SECONDARY | Data are presented as frequency (percentage) or mean ± standard deviation, depending on data type and distribution. A detailed statistical analysis plan was prepared and completed prior to database lock. Primary and secondary outcomes were evaluated using Repeated Measure ANOVA and the Friedman test. Statistical analys... | PMC10512624 | |
Results | Overall, 58 patients were assessed for eligibility, of whom 44 were consented and randomized. The corresponding flowchart is presented in Fig. Participant flow during the studyDuring the 6-month intervention period, 2 participants in the intervention group and 3 participants in the control group dropped out of the stud... | PMC10512624 | ||
Safety | muscle cramps | ADVERSE EFFECTS | No treatment-related serious adverse effects were observed during the period of the study. During the intervention period, one patient had muscle cramps after the first exercise session, but this was not serious or harmful. | PMC10512624 |
Discussion | CKD, chronic kidney disease, CKD-MBD, bone loss, HD, fracture, bone mineral disorders, bone disorder, intradialytic, renal insufficiency, intradialytic exercise | HIGH TURNOVER BONE DISEASE, BONE LOSS, METABOLIC BONE DISEASE, LIVER DISEASE, COMPLICATION, BONE DISORDER, SECONDARY, RENAL HYPERPARATHYROIDISM, RENAL INSUFFICIENCY | The purpose of this study was to examine the effects of intradialytic exercise on calcium, phosphorous and parathyroid hormone. Our primary findings showed that the 6-month intradialytic concurrent exercise program was effective in improving PTH levels, reducing serum phosphorous and improving serum calcium and calcium... | PMC10512624 |
Conclusion | Intradialytic, bone mineral disorders, HD | Intradialytic exercise performed for at least 60 min during thrice weekly dialysis sessions improves bone mineral metabolism in adult patients receiving HD and perhaps decrease all-cause mortality in these patients. Further studies should focus on observing the effect of different types of exercise on bone mineral diso... | PMC10512624 | |
Acknowledgements | RENAL | The authors would like to express their heart-felt gratitude to all the investigators for their contribution to the trial, especially Dr. Hugo Corrêa1 and Dr. João Viana and all the staff of the dialysis center for their efforts and patience in helping to maintain the standards of the research, as well as all patients ... | PMC10512624 | |
Authors’ contributions | MAT: conceptualizing the study, project leader of the study, conducting the study, writing of the manuscript, supervising of the analysis, interpreting the results, approval of the manuscript, KW: conceptualizing of the study, interpreting the results, co-writing of the manuscript, supervising of the manuscript, approv... | PMC10512624 |
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