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Outcome Measures and Statistical Analysis | The primary outcome measure was the rate of viral clearance, expressed as a slope coefficient [All analyses were done in a modified intention-to-treat (mITT) population, comprising patients who had ≥3 days follow-up data. A sensitivity analysis showed excellent agreement between all the models ( | PMC10640773 | ||
RESULTS | RECRUITMENT | The trial began recruitment on 30 September 2021. On 10 June 2022, remdesivir enrollment was stopped as the prespecified success margin had been reached. Of the 439 patients screened by that time, 337 were randomized to either remdesivir (67 patients), no study drug (69 patients), or to other interventions (201 patients) [Consolidated Standards for Reporting Trials diagram of the PLATCOV phase 2 open-label, randomized, controlled adaptive platform trial for remdesivir in Thailand and Brazil. Enrollment ended 10 June 2022. Abbreviations: ATK, antigen test kit; BMI, body mass index; ECG, electrocardiogram; mITT, modified intention-to-treat; PCR, polymerase chain reaction. | PMC10640773 | |
Virological Responses | oropharyngeal virus | CORONAVIRUS, VIRUS, SEVERE ACUTE RESPIRATORY SYNDROME | All analytical models of oropharyngeal virus clearance were in excellent agreement. Point estimates and credible intervals (CrIs) were similar, although the nonlinear model gave slightly smaller effect size estimates (Effect of parenteral remdesivir on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral clearance. Left: Median SARS-CoV-2 oropharyngeal virus clearance profiles following remdesivir (darker/grey) and no study drug (lighter/green). Right: estimated treatment effects under the linear model (light with circle) and nonlinear model (dark with triangle). The thick lines show the 80% credible interval (CrI); the thin lines show the 95% CrI.Individual estimate of the viral clearance half-lives with point estimates (squares) and 80% credible intervals (lines). The vertical dashed lines show the median population viral clearance half-lives by treatment arm (lower: no study drug; upper: remdesivir). The median estimated viral clearance half-lives under the linear model were 12.8 (range, 4.8–50.0) hours in the remdesivir arm and 18.0 (range, 3.6–46.7) hours in the contemporaneous control arm. | PMC10640773 |
Adverse Effects | ADVERSE EVENTS | The oropharyngeal swabbing and all treatments were well-tolerated. There were 3 serious adverse events (SAEs) in the control arm and 1 SAE in the remdesivir arm ( | PMC10640773 | |
DISCUSSION | COVID-19 illness | DISEASE PROGRESSION, DISEASE, DECAY, TROPICAL DISEASES | This comparative in vivo pharmacodynamic assessment shows that remdesivir accelerates viral clearance in early COVID-19, as would be expected from an effective antiviral drug. Continued uncertainty over the efficacy and value of different COVID-19 treatments has resulted in substantial variation in therapeutic guidelines and clinical practice across the world. From 20 November 2020 until 22 April 2022, the 8 successive versions of the WHO's “Therapeutics and COVID-19: Living Guideline” gave a conditional recommendation It has become increasingly clear that antivirals are more effective in early COVID-19, when viral burdens are highest, than in late-stage disease (i.e., in hospitalized patients requiring oxygen or ventilation) where viral burdens have declined, inflammatory processes dominate, and anti-inflammatory interventions are most effective [In early COVID-19 illness viral load decay from the nasopharynx and oropharynx is approximately log-linear, although there is substantial interindividual variation in rates of clearance and baseline viral loads. The approximate 40% average acceleration in viral clearance rate observed with remdesivir in this study is similar in magnitude to that observed in trials with the oral drug molnupiravir, although the assessment methodologies were different [This study has several limitations. The relationship between rate of viral clearance and therapeutic efficacy has not been well established, although across tested antiviral interventions there is a general direct relationship between acceleration of viral clearance and prevention of disease progression [Remdesivir continues to have a role in the treatment of COVID-19 for certain populations [Summary of Patient Characteristics Included in the 2 Modified Intention-to-Treat Populations (N = 131)Abbreviations: BP, Bangplee Hospital, Thailand; HTD, Hospital for Tropical Diseases, Thailand; SD, standard deviation; UFMG, Universidade Federal de Minas Gerais, Brazil; VJ, Vajira Hospital, Thailand.
| PMC10640773 |
Supplementary Data | PMC10640773 | |||
Supplementary Material | Click here for additional data file. | PMC10640773 | ||
Notes | PMC10640773 | |||
References | PMC10640773 | |||
Background | Water pipe smoking by women threatens their health. Therefore, it is necessary to take measures to reduce this unhealthy behavior. This study aimed to determine the effect of happiness-based education on women’s success of water pipe smoking cessation and happiness. | PMC10629038 | ||
Methods | Fordyce happiness | This quasi-experimental study was conducted on female water pipe smokers in Iran, from September to January 2021. The participants (n = 68) were selected using convenience sampling and assigned to the intervention and control groups (34 subjects per group) by blocked randomization. The intervention group received a happiness-based education for one month (eight sessions) based on the Fordyce happiness program. The control group did not receive any special education. Data were collected using the Water Pipe Dependence Scale and the Oxford Happiness Questionnaire before and two months after the intervention. Data were analyzed using descriptive statistics, Chi-square, Fisher’s exact test, Independent t-test, Mann-Whitney, and Wilcoxon tests by SPSS software version 22. | PMC10629038 | |
Results | Two months after the intervention, the mean change in the happiness score was significantly higher in the intervention group (2.32 ± 2.31) than that in the control group (-0.29 ± 1.81) (P < 0.001). Furthermore, the mean change in the score of water pipe dependence was significantly different between the intervention (-1.44 ± 1.4) and control (0.38 ± 0.85) groups (P < 0.001). | PMC10629038 | ||
Conclusion | Fordyce happiness | The results showed that education based on Fordyce happiness program can increase the success of water pipe smoking cessation and happiness in women. Therefore, it is recommended to use similar interventions in women’s health promotion programs. | PMC10629038 | |
Keywords | PMC10629038 | |||
Background | Fordyce believes, happiness, depression, deaths, Fordyce | SECONDARY, FORDYCE | Tobacco use kills eight million people worldwide annually. Among these, seven million and about 1.2 million deaths are secondary to direct tobacco use and smoke exposure, respectively [The spread and popularity of WPS in the current societies have been caused by several factors such as the misperception of its harmlessness or being less harmful than cigarette smoking, social acceptance, easy access to various tobacco flavors, and the low cost of hookah consumables [Psychological factors are among the other risk factors for the tendency toward WPS. Individuals with depression and those with sadness and lower levels of happiness are more likely to smoke water pipe and less likely to quit [As one of the pioneers of happiness-related studies, Fordyce believes that happiness is one of the gifts provided by nature to human and encompasses a wide range of fundamental efforts for survival, to great scientific and artistic achievements. Fordyce considers that the level of people’s happiness can be increased through education [A review of previous studies by the present research team showed that no study is available on the effect of a happiness-based interventions on tobacco use cessation. The WPS is relatively prevalent in the southern cities of Iran. and the women’s tendency toward tobacco use is increasing [ | PMC10629038 |
Methods | PMC10629038 | |||
Study design and participants | cancer, psychological disorders | CANCER, HEART DISEASES, DISEASES | The present quasi-experimental study was conducted in Gerash, southern Iran, from September to January 2021. The sample size was calculated according to a previous study aimed at determining the effect of group education programs on happiness in women [Sample was selected by the convenience method. In this way, all eligible women who visited the two primary healthcare centers to receive any services except smoking cessation or psychological services were included in the study. Randomization was done by the block method, in which the 17 random blocks with a capacity of four individuals were formed. The order of the blocks was set by random block generator software. Sampling continued until the sample size in each group was completed. Finally, 34 individuals participated in each group. Inclusion criteria were willingness to participate in the study, an age of 18–60 years, literacy, no history of cigarette smoking and drug use, and not suffering from such diseases as cancer, psychological disorders, and known heart diseases. In addition, a happiness score of < 44, traditional tobacco use, and no use of aromatic and industrial tobaccos were among the inclusion criteria. Exclusion criteria were failure to complete the questionnaires (failure to complete 20% of the main questions), failure to participate in the educational program completely, and initiation of WPS cessation treatment in other methods. There was no sample attrition, and finally the data related to 34 people in each group were analyzed. | PMC10629038 |
Data collection tools | DISEASE | Data collection tools included a general information form, and the Persian versions of Oxford Happiness Inventory (OHI) and Lebanon Water Pipe Dependence Scale-11 (LWDS-11). Data were collected before and two months after the intervention in both groups. A researcher and a trained research assistant collected the data. They were in regular contact with each other during the data collection and were coordinated in this field.The general information form consisted of questions about age, marital status, education, employment status, underlying disease, using medication, age of the onset of WPS, frequency of WPS per day, and other questions about WPS status.Developed by Argyle, Martin, and Crossland (1989), the OHI consists of 29 items each containing four phrases [The LWDS-11 was designed by Salameh et al. (2008) and contains 11 questions in which the first four multiple-choice questions concern the level, duration, and frequency of use as well as the cost of WPS. The choices of the four questions are scored as 0 (never), once (1), sometimes (2), and always (3). Other questions are about the psychological effects of WPS and are scored between 0 and 3. The total scores of this questionnaire range from zero to 33 and a higher score indicates more dependence on WPS. Salameh et al. confirmed face, convergent and discriminative validity of the LWDS-11, and approved its reliability by a Cronbach’s alpha of 0.83 [ | PMC10629038 | |
Intervention | Fordyce happiness, Fordyce | EVENTS, FORDYCE | The intervention included a happiness-based education based on the Fordyce happiness program. Fordyce introduced a program consisting of 14 fundamentals. These fundamentals were 14 typical characteristics of happy people that he believed average people can acquire. These fundamentals are: a-being busy and more active; b-spending more time socializing; c-being productive in a meaningful work; d- better organizing and planning for everything; e-stopping worrying; f-reducing expectations and one’s wishes; g-developing positive optimistic thinking; h- being focused on the present time; i-working on a healthy personality; j-creating an outgoing social personality; k-to be oneself; l-eliminating negative feelings and problems; m-to put happiness as the most important priority of oneself; and n-noting that close relationships are the most important sources of happiness [
Contents of happiness-based education sessionsStarting a new sport or activityDoing good work and reporting it in the groupRecording imagination about positive activities in the coming future or positive events in the pastDoing the thought stopping technique to reduce negative thoughtsSocial problem-solving, creativity in establishing relationships, and describing its effects in the form of examplesProviding a technique for increasing social problem-solving skills and creativity in establishing relationships with oneself and others.Starting a new sport or activityPreparing a list of tasks in order of priority (weekly schedule) | PMC10629038 |
Data analysis | Data were analyzed using SPSS software version 22. Descriptive tests were used to describe the data. Qualitative variables between the intervention and control groups were compared using the Chi-square test and Fisher’s exact test. Mean differences of water pipe dependence scores (P = 0.002), mean water pipe dependence scores before (p = 0.02) and after (p < 0.001) the intervention, and happiness scores before intervention (P = 0.009) did not have a normal distribution. The before-after, between-group and within-group variables were compared by the independent t-test or the Mann-Whitney test and the Wilcoxon test, respectively. The Cohen’s d effect size was calculated to evaluate the clinical significance of the findings. The effect sizes of 0.8, 0.5, and 0.2 were considered large, medium, and small, respectively [ | PMC10629038 | ||
Results | The mean age of participants was 38.79 ± 11.67 years, with mean ages of 36.41 ± 10.12 and 41.18 ± 12.75 in the intervention and control groups, respectively (P = 0.106). The two groups were not statistically different in terms of demographic variables and water pipe use status (Tables
Comparison of demographic variables between intervention and control groups*Fisher’s exact test **Chi-square test
Comparison of water pipe use status (quantitative variables) between intervention and control groups* Mann-Whitney testThe results showed that the intervention and control groups were not statistically different in terms of mean happiness scores before the intervention (P = 0.43). However, a statistically significant difference was observed after the intervention (P = 0.001) so that the post-intervention mean score of happiness was higher in the intervention group than in the control group. In addition, the intragroup mean change in the happiness score was significantly higher in the intervention group (2.32 ± 2.31) than that in the control group (-0.29 ± 1.81) after the intervention (P < 0.001) (Table According to the results, the mean scores of water pipe dependence between the intervention and control groups were not statistically significant before the intervention (P = 0.814). Two months after the intervention, however, the mean score of water pipe dependence was lower in the intervention group (9.02 ± 1.56) than that in the control group (10.35 ± 2.99) (P = 0.055). The mean change in the score of water pipe dependence was significantly different between the intervention (-1.44 ± 1.4) and control (0.38 ± 0.85) groups (P < 0.001) (Table
Comparison of water pipe use status (qualitative variables) between intervention and control groups*Fisher’s exact test **Chi-square test
The comparison of happiness and water pipe dependence between the intervention and control groups*Mann-Whitney test **Independent t-test ***Wilcoxon’s test † Scores range from 0 to 87. ǂ Mean difference = posttest-pretest § Scores range from 0 to 33 | PMC10629038 | ||
Discussion | Fordyce happiness | This study aimed to determine the effect of happiness-based education on the success of WPS cessation and the happiness of women. The results indicated that the happiness scores of the intervention group improved significantly after the intervention. In addition, their water pipe dependence reduced. Hence, we can conclude that the intervention has had a significant effect on people’s happiness and success in WPS cessation.Similar to our findings, the effectiveness of happiness-based interventions on the happiness and mental health of people and different groups has also been shown in previous studies. In an Iranian study, six sessions of education based on Fordyce happiness program increased nurses’ happiness [The current findings also revealed the positive effect of the happiness-based intervention on reducing water pipe dependence. Despite not finding studies of happiness-based interventions for water pipe users, similar findings were reported using some emotion management and positive psychology interventions [Altogether, the present results revealed that the happiness-based intervention improved the happiness and success of WPS cessation in women. Moreover, the high effect sizes of mean differences of changes in happiness and water pipe dependence in the present study indicate the clinical significance of the findings. It is noteworthy that the subjects in the intervention group were water pipe smokers for about 8 years, and 85.3% of these participants had family members who were water pipe smokers. The results of a study showed that people who smoked water pipe for more than 12 months had lower intention to quit compared to people who had a shorter smoking duration [According to our findings, most of the participants were housewives in both groups, and the reason for WPS was mentioned by the majority of participants to be entertainment and gathering together. Therefore, it is recommended to use culture-appropriate training, especially for housewives, about healthy entertainment and filling their leisure time as a suitable solution to reduce their tendency toward water pipe use. Future studies are recommended to assess the effectiveness of such interventions. | PMC10629038 | |
Strengths and limitations | FORDYCE | The presentation of the intervention using the group formed in the social network is one of the strengths of this study. Moreover, the intervention was implemented by a nurse in collaboration with a psychologist. We showed that with an intervention based on the Fordyce program and using a feasible and convenient method, a nurse was able to create a positive impact on the participants. These results showed the important role of nurses in improving happiness and quitting water pipe in women at the community level. Therefore, the positive effects of the intervention are promising for more participation of nurses in community health promotion services, particularly in the area of women’s health. Moreover, similar interventions that have been used in the field of emotion management [A limitation of this study was the possibility of information dissemination between the two groups. To prevent this problem, only one person from each family was included in the study to reduce the possibility of sharing educational materials between members of the intervention and control groups. Furthermore, it is worth noting that participants entered the study gradually and thus did not know the other participants. After random assignment, the people in the intervention group joined a virtual social group, but they and the people in the control group did not know each other.The other limitation of the study was the short follow-up duration for the effectiveness of interventions. It seems that interventions with long-term follow-up can better show the effects of such an intervention. | PMC10629038 | |
Acknowledgements | This manuscript was extracted from the Master’s thesis of Samira Dehkami and approved by the Vice Chancellor for Research and Technology of Shiraz University of Medical Sciences, Shiraz, Iran. Hereby, we would like to thank Vice Chancellor for Research and Technology of Shiraz University of Medical Sciences for financial support in conducting the research and Mr. A.M. Keshtvarez and the Clinical Research Development Center of Namazi Hospital who collaborated in data analysis. Appreciation goes to Mrs. S. Rezaei for her cooperation in psychological counseling and Dr Fatemeh Khademian for her sincere collaboration in this research. Also, we would like to express our gratitude to the respected authorities of the health centers of Gerash city and all the individuals who participated in this study. | PMC10629038 | ||
Authors’ contributions | ZKh, SD, and KhR made substantial contributions to the conception and design of the study. Data was collected by SD. Data analysis and interpretation were done by ZKh and SD. SD conducted the intervention. ZKh and SD participated in drafting the manuscript. ZKh, SD and KhR revised the manuscript critically for important intellectual content and final approval of the manuscript. | PMC10629038 | ||
Funding | The present study was financially supported by the Vice Chancellor of Research of Shiraz University of Medical Sciences, Shiraz, Iran (Grant No. 22086). The funding body did not play any roles in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. | PMC10629038 | ||
Data Availability | Data resources and statistical analysis outputs can be provided by the corresponding author (Zahra Khademian) on reasonable request. | PMC10629038 | ||
Declarations | PMC10629038 | |||
Ethics approval and consent to participate | For this study, the necessary approvals were obtained from the Ethics Committee of Shiraz University of Medical Sciences (ethics code: IR.SUMS.REC.1399.1034) and the officials of the health centers. All methods were carried out in accordance with Declaration of Helsinki and relevant guidelines and regulations. The objectives and process of the research were explained to the participants who were assured of the confidentiality of the information. All participants signed a written informed consent form. | PMC10629038 | ||
Consent for publication | Not applicable. | PMC10629038 | ||
Competing interests | None of the authors have any competing interests. | PMC10629038 | ||
Abbreviations | Lebanon Water Pipe Dependence Scale 11Oxford Happiness InventoryStatistical Package for the Social SciencesWater pipe smoking | PMC10629038 | ||
References | PMC10629038 | |||
Keywords | post-traumatic stress disorder, PTSD | POSITIVE | The last few decades have seen increasing interest in the use of cannabis for post-traumatic stress disorder (PTSD). Recent attempts to evaluate the clinical efficacy of cannabis for PTSD were inconclusive and generalizability was limited by undesirable features of the study drug. The present clinical trial evaluated the effects of a commercially available chemovar that was delivered by vaporization. The study was designed as a randomized placebo-controlled cross-over study with three conditions; however, only five individuals completed the trial, and analysis of the placebo effect was not possible. Results identified positive changes consistent with medium-sized within-subject effects for cannabis in the treatment of PTSD. Positive trending results and high patient need mandate future studies of cannabis for the treatment of PTSD. | PMC10493009 |
Introduction | PTSD | Cannabis is a flowering plant valued for millennia due to its medicinal and psychoactive properties. Interest in the therapeutic application of cannabinoids has re-emerged after decades of marginalization, with the treatment of mental health conditions among the most prominent applications [Preclinical studies implicate the endocannabinoid system in the etiology of PTSD [ | PMC10493009 | |
Methods | Administered PTSD | RECRUITMENT | This trial was registered on ClinicalTrials.gov (NCT02517424) and approved by the Clinical Research Ethics Board at the University of British Columbia (H16-01026). Participants provided written informed consent prior to participating. The study was designed as a randomized blinded placebo-controlled cross-over study with three conditions: placebo cannabis (< 1% THC and < 1% CBD), cannabis with 10 + / − 2% THC and 10 + / − 2% CBD, and cannabis with 10 + / − 2% THC and < 1% CBD. These chemovars were selected to allow for a proposed comparison between a psychoactively inert product and cannabis products that varied in CBD but were equivalent in THC. The cross-over design was selected in an attempt to efficiently allow comparisons of all three groups while providing access to one of the two active study drug conditions for all participants. Participants were provided a portable cannabis vaporizer and two grams of cannabis per day for three weeks of ad lib use. Target recruitment was for 42 participants. Thirty-two individuals were assessed for eligibility; 24 did not meet inclusion criteria and two declined to participate. Failure to meet our recruitment target resulted in the study terminating with only six participants (age range 35–65; 1 female) enrolled of whom five completed the entire protocol. Due to low power, we revised our analysis to aggregate active conditions and test within-subject change from baseline to the end of active treatment. The primary outcome was a change in scores on the Clinician Administered PTSD Scale (CAPS-5) [Consort flow design. Note: Stages 1 and 2 include 2 weeks of washout/cessation followed by 3 weeks of ad lib cannabis use | PMC10493009 |
Results | PTSD, DSM-5, Administered PTSD | Comparison of CAPS scores pre and post treatment identified a trend toward reduction in PTSD symptoms (Patient-level change in total PTSD ratings on CAPS-5. Note: CAPS-5, Clinician Administered PTSD Scale for DSM-5; potential range = 0–80 | PMC10493009 | |
Acknowledgements | The research team would like to acknowledge the time, effort, and trust of the individuals who participated in the study. | PMC10493009 | ||
Authors’ contributions | ZW, IM, and PL designed the study. ZW analyzed the data and was a major contributor in writing this manuscript. MSP assisted with manuscript writing, revision, and formatting. DW, KC, and MSP collected participant data. KO facilitated clinical research activities. All authors read and approved the final manuscript. | PMC10493009 | ||
Funding | The study was funded by Tilray through a Clinical Trial Agreement with the University of British Columbia. | PMC10493009 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10493009 | ||
Declarations | PMC10493009 | |||
Ethics approval and consent to participate | This trial was registered on ClinicalTrials.gov (NCT02517424) and approved by the Clinical Research Ethics Board at the University of British Columbia (H16-01026). Participants provided written informed consent prior to participating. | PMC10493009 | ||
Consent for publication | Not applicable. | PMC10493009 | ||
Competing interests | BLOOM | Philippe Lucas was Vice President, Global Patient Research and Access, for Tilray, the study sponsor, during the course of the clinical trial, and his compensation included stock options for Tilray.Zach Walsh has received research support from Tilray to conduct this study and has also received research support from DOJA who are a licensed producer of cannabis. Dr Walsh is a former Director of Indigenous Bloom which is a company that works to provide opportunities to Indigenous communities in Canada to engage in cannabis cultivation and sales.Kim Crosby, Michelle St. Pierre, and Drew DeClerck received paid research assistantships from MITACS and Tilray to assist with the implementation of the study. | PMC10493009 | |
References | PMC10493009 | |||
1. Introduction | Schizophrenia, schizophrenia, cardiovascular disease, pain | DISEASE, CARDIOVASCULAR DISEASE, DISORDERS, SECONDARY | Background: This study aimed to evaluate the effect of two different types of physical intervention on sedentary behavior and clinical changes in people with schizophrenia. Method: This is a clinical trial including people with schizophrenia in regular outpatient care who realized a 3-month exercise protocol and were separated into two groups: aerobic physical intervention (API) and postural physical intervention (PPI). All participants performed an assessment of (a) functional capacity through a 6 min walk test (6MWT), (b) flexibility using Well’s bench, (c) disease severity using the Brief Psychiatric Rating Scale (BPRS), (d) quality of life using the SF-36 Questionnaire and (e) physical activity using the Simple Physical Activity Questionnaire (SIMPAQ). Results: Thirty-eight patients with schizophrenia completed the intervention (24 patients in API and 14 patients in PPI). Regarding sedentary behavior, there was an improvement in the API group in the time exercising and in the PPI group concerning time in bed, time walking and exercising. Regarding quality of life, there was an improvement in the API group (functional capacity) and in the PPI group, there was an improvement in physical limitation, pain and emotional limitations. In the API group, there was an improvement in BMI (body mass index), diastolic blood pressure and systolic blood pressure. Functional capacity was improved only in the PPI group. There was no change in flexibility and disease severity. Conclusions: The study demonstrated a change response in the physical and mental aspects in people with schizophrenia after a change in sedentary behavior.Schizophrenia is among the most disabling and economically catastrophic medical disorders, ranked by the World Health Organization as one of the top 10 illnesses contributing to the global burden of disease [There is growing interest in the assessment and improvement of global functioning in these patients, with the expansion of physical interventions together with traditional clinical and pharmacological care to increase life expectancy and quality of life. Increased sedentary lifestyles and reduced physical activity are extremely frequent in schizophrenia, which are independent but modifiable risk factors for a decrease in cardiovascular disease and premature mortality in these people [Functional capacity is connected and related to the degree of physical activity within this population [Regular exercise has positive effects on both the body and mind [The primary aims of the present study were the following: to evaluate the effects of the two techniques—aerobic and postural interventions—over sedentary behavior. The secondary aims were to compare the physical (body mass index, blood pressure, flexibility, functional capacity) and mental (quality of life and disease symptomatology) effects of different interventions in people with schizophrenia. | PMC9958543 |
2. Methods | PMC9958543 | |||
2.1. Trial Design | schizophrenia | This is a non-randomized clinical trial of two physical interventions (aerobic physical intervention (API) and postural physical intervention (PPI)) over three months in two groups of stable outpatients with diagnosis of schizophrenia. API was applied in patients at a public health facility (Psychosocial Attention Center (CAPS)) in Camaquã, a mid-sized town of southern Brazil, and PPI in patients of the Schizophrenia Outpatient Program (Prodesq) of a major University Hospital—Hospital de Clínicas de Porto Alegre (HCPA)—in a large-sized town in southern Brazil. | PMC9958543 | |
2.2. Participants | psychiatric, DSM-5 | DISORDERS | Stable outpatients under regular treatment received a psychiatric diagnosis after a three-step procedure consisting of (1) clinical observation with at least 3 evaluations; (2) a family interview; and (3) a review of their medical records performed by a trained psychiatrist. The selected patients met the following inclusion criteria: Diagnostic and Statistical Manual of Mental Disorders (DSM-5) [ | PMC9958543 |
2.3. Ethics | The study was registered in the Brazilian Research Registry under No. 43408615.7.0000.5327, in the Brazilian Registry of Clinical Trials (ReBEC) under No. RBR-2h2hjy and approved (150066) by the Research Ethics Committee of Hospital de Clínicas de Porto Alegre (HCPA). Patients and their legal guardians provided written informed consent after reading and understanding the intervention program and their rights. | PMC9958543 | ||
2.4. Clinical Assessment | RECRUITMENT | After patient recruitment, previously trained professionals performed a standardized clinical and physical assessment of the study to participants before physical intervention and after 3 months of treatment. | PMC9958543 | |
2.5. Sedentary Lifestyle | Measured by the Simple Physical Activity Questionnaire (SIMPAQ). It is a 5-item clinical tool designed to assess physical activity among populations at high risk of sedentary behavior. The physical activity questionnaire evaluates the last seven days and includes time in bed, sedentary time, time spent walking, type and time spent exercising, and time spent in other activities, including leisure, domestic, work and transportation activities [ | PMC9958543 | ||
2.6. Disease Severity | psychiatric | Measured by the Brief Psychiatric Rating Scale (BPRS). It is one of the most widely used instruments to evaluate the presence and severity of various psychiatric symptoms including the Brazilian Unified Health System (SUS) for patient’s monitoring [ | PMC9958543 | |
2.7. Physical Performance | THORACIC | Measured by the Six-Minute Walking Test (6MWT). Two trained and certified physical therapists applied 6MWT following the American Thoracic Society Guidelines (2002) [ | PMC9958543 | |
2.8. Stretching | BENDING | Measured by the Well’s Bench sit and reach flexibility test. It measures lower limb and hip joint flexibility, with the participant fully extended the legs, with the soles of their feet against the bench, slowly bending and projecting forward as far as possible, and fingers sliding along a scale. The total distance reached after three (3) attempts provided the final score [ | PMC9958543 | |
2.9. Quality of Life | pain | Measured by the Medical Outcomes Study 36-Item Short Form—SF-36. This instrument is a validated questionnaire method with high sensitivity to detect functional status, among other aspects of quality of life. It includes eight multiple-item subscales of functional capacity, physical limitation, pain, general health, vitality, social aspects, emotional limitations and mental health. The total score on each SF-36 subscale ranges between 0 and 100, and higher the score is, the better the patient is [ | PMC9958543 | |
2.10. Physical Intervention | PMC9958543 | |||
2.10.1. Aerobic Physical Intervention [API] | This 12-week program included a 1 h session of aerobic exercise twice a week. It measures exercises by a digital rate monitor (POLAR FT1 | PMC9958543 | ||
2.10.2. Physical Intervention | hip abductors | Postural Physical Intervention [PPI]: The 12-week program included twice a week 1 h sessions of postural exercises. Trios or quartets of subjects received an intervention, beginning with a 5 min warm-up with a stationary walk, followed by 15 min of muscle flexibility and joint mobility exercises. After 25 min of global muscle resistance exercises (the muscular groups emphasized were the paravertebrals, abs, extenders, flexors, adductors, hip abductors, shoulders, knees and elbows flexors and extenders), the session ended with 15 min of body awareness work through breathing. The evolution of the exercises, as well as the use of accessories such as balls, elastics, dumbbells, etc., respected the individuality of each one. A properly trained professional conducted the consultations, demonstrating the exercises and correcting them when necessary. | PMC9958543 | |
2.11. Statistical Analyses | Statistical analyses used SPSS version 20.0, with categorical variables described by frequencies and percentages, and tested for symmetry by the Kolmogorov Smirnov test. Quantitative variables with symmetrical distribution were expressed by means and standard error or means and standard deviation, and those with asymmetric distribution by median, minimum and maximum. Quantitative variables with symmetrical distribution used a Student’s | PMC9958543 | ||
3. Results | Out of the 103 patients in the API group that were initially invited to participate, 26 agreed to participate and met the inclusion criteria. Of these, 24 patients (92%) completed the physical exercise intervention. Dropouts consisted of two patients (8%) that did not achieve the minimum attendance. Regarding in PPI group derived from 81 patients that received invitation to the study, from these, 17 agreed to participate. Of these, 14 patients (82%) completed the postural intervention. Dropouts consisted of three patients (18%) that did not achieve minimum attendance (The two groups were homogeneous, except in the body mass index (BMI). The API group had higher BMI (In the API group, the systolic blood pressure decreased from 125 mmHg (SD = 10.6) to 121.3 mmHg (SD = 11.2) and diastolic blood pressure decreased from 82.9 mmHg (SD = 10.8) to 77.9 mmHg (SD = 11.8), (On the Simpaq scale (Regarding quality of life, as quantified by the questionnaire SF-36 (Regarding physical performance, 6MWT (BPRS changes were similar among the API and PPI groups. There was no difference in all 18 items between groups, i.e., (1) Worry about body ( | PMC9958543 | ||
4. Discussion | schizophrenia, injuries | DISEASE | The major finding of the study was that the aerobic physical intervention program reduced weight, body mass index and blood pressure and increased time exercising, whereas the postural physical intervention showed an improvement in sedentary behavior through SIMPAQ and 6MWT. No effects were seen in flexibility and disease severity in both groups.The increase in the practice of physical activity and the reduction of sedentary behavior are gaining more visibility in research and clinical attention due to the feasibility and effectiveness of exercise programs integrated into the range of therapeutic approaches to schizophrenia. On the SIMPAQ scale in the initial assessment, the PPI group spent more time staying in bed than the API group; the API group initially spent 41%/day sleeping and after the intervention spent 40%, and the PPI group spent 45%/day sleeping and after the intervention spent 42%. People with schizophrenia engage in less physical activity than the general population [Patients in both groups received no specific dietetic orientation, and only API had an effect on BMI (The study evidenced a significant improvement in several domains of the SF-36 scale, in support of several previous studies demonstrating the need for new interventions to increase the quality of life in patients diagnosed with schizophrenia. The PPI group showed similar effects of other interventions such as yoga and dance. Cramer [Several physiological effects of stretching included elastic property referring to the capability of the tendon muscle unit to return to its original length after being stretched; the analgesic effect; the anti-inflammatory effect in the injuries of muscle fibers, among others [On the other hand, unexpectedly, the functional capacity in the API group did not show significant improvement after the intervention, only in the PPI group. Patients in the API group were 13% below the predicted minimum level and after the intervention remained as such (15% below the expected) and patients in the PPI group were 29% below the minimum predicted level, improving 27%. This also occurred in other studies. Vancampfort [The limited effect of interventions can relate to the following study limitations: (1) limited sample size that may have interfered with our result; and (2) limited time intervention (perhaps the 3 month duration in physical interventions did not provide enough time for clinical and functional response). The worsening of some aspects such as the total BPRS scores or the unexpected results of the 6MWT represents a great challenge. We should have included a third group of patients with schizophrenia who did not realize any physical intervention. In this article, we do not consider the doses and types of antipsychotic drugs or the side effects that they can cause; however, they should be considered in future studies. Another important limitation is the difficulty to standardize specific exercise, real effort dispended and type, frequency and intensity of practice. These factors can affect the outcomes. Additionally, we must consider the effect of the difficulty in patient management and patient motivation affecting observed outcomes. | PMC9958543 |
5. Conclusions | schizophrenia | In conclusion, the aim of the present article was to provide a modification of sedentary behavior through aerobic and postural exercise in people with schizophrenia, in addition to observing its effects on physical and mental health. This study showed that both protocols were effective in this population, which are otherwise lacking in complementary therapies. The aerobic physical intervention improved physical health outcomes such as weight, BMI, blood pressure and more time exercising. The postural physical intervention improved the sedentary behavior (SIMPAQ and 6MWT) and quality of life. However, clinical studies are still needed to develop better evidence-based physical training programs for patients with schizophrenia, including greater accessibility and better protocols for types and intensities of exercises. | PMC9958543 | |
Author Contributions | M.F.S. participated in the elaboration of the research project, data collection, intervention, statistical analyses, and writing of the manuscript; V.B.C. collaborated in data collection; and P.B.-d.-A. provided orientation in project elaboration, data acquisition, training in clinical scales, statistical analyses, and writing of the manuscript. All authors have read and agreed to the published version of the manuscript. | PMC9958543 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Ethics Committee of Hospital de Clínicas de Porto Alegre (150066 and date approval 07/22/2017). | PMC9958543 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9958543 | ||
Conflicts of Interest | The authors declare that this research was conducted in the absence of any commercial or financial relationships that could be construed as potential conflicts of interest. | PMC9958543 | ||
References | SE, schizophrenia | Study Flowchart: Aerobic physical intervention (API) and postural physical intervention (PPI) in people with schizophrenia.Relationship between the distances walked in the 6 min walking test (6MWT) and the upper and lower limit predicted of patients who performed the aerobic physical intervention (API) and 14 cases that performed the postural physical intervention (PPI) in people of schizophrenia.Table of sample characteristics of 24 cases that performed the aerobic physical intervention (API) and 14 cases that performed the postural physical intervention (PPI) in people with schizophrenia.SE, Standard error; * Student’s Table with the pre- and post-SF-36 quality of life scale and SIMPAQ scale of the 24 cases who realized aerobic physical intervention (API) and 14 cases who realized postural physical intervention (PPI) in people with schizophrenia.Data is presented as median (minimum–maximum); * | PMC9958543 | |
Background | delirium, mouth-breathing | Emergence delirium (ED) is generally occurred after anesthesia associated with increased risks of long-term adverse outcomes. Therefore, this study aimed to evaluate the efficacy of preconditioning with nasal splint and mouth-breathing training on prevention of ED after general anesthesia. | PMC10483790 | |
Methods | REGRESSION | This randomized controlled trial enrolled 200 adult patients undergoing ESS. Patients were randomized to receive either nasal splinting and mouth breathing training (n = 100) or standard care (n = 100) before surgery. The primary outcome was the occurrence of ED within 30 min of extubation, assessed using the Riker Sedation-Agitation Scale. Logistic regression identified risk factors for ED. | PMC10483790 | |
Results | Totally 200 patients were randomized and 182 aged from 18 to 82 years with 59.9% of males were included in the final analysis (90 in C-group and 92 in P-group). ED occurred in 16.3% of the intervention group vs. 35.6% of controls (P = 0.004). Male sex, smoking and function endoscopic sinus surgery (FESS) were independent risk factors for ED. | PMC10483790 | ||
Conclusions | delirium | Preoperative nasal splinting and mouth breathing training significantly reduced the incidence of emergence delirium in patients undergoing endoscopic sinus surgery. | PMC10483790 | |
Trial Registration | ChiCTR1900024925 ( | PMC10483790 | ||
Keywords | PMC10483790 | |||
Background | delirium, motor agitation, agitation, inconsolability, dissociation of consciousness | COMPLICATIONS | Emergence delirium (ED, aka emergence agitation, EA), which referring to a short-term state of dissociation of consciousness during the recovery from general anesthesia, manifested with motor agitation, incoherence, inconsolability, and unresponsiveness, is the most common neuropsychiatric complications after surgery [Multiple factors related to characteristics of patients, anesthesia, and surgery have been linked with ED risks [Functional endoscopic sinus surgery (FESS) is a minimally invasive technique used to restore sinus ventilation and normal function [ | PMC10483790 |
Methods | PMC10483790 | |||
Study design | mouth-breathing | BLIND | This is a randomized, single blind, parallel, controlled study to evaluate the efficacy of nasal splinting and mouth-breathing training in preventing ED in adults after FESS. Adult patients were 1:1 randomly allocated to receive preconditioning treatment or control treatment. The random sequences were generated by computer and concealed until the patients were included. Patients in the preconditioning treatment group received nasal splint and mouth-breathing training before FESS, and no any interventions were performed in the control group. The study protocol has been approved by the Shanghai General Hospital Institutional Review Board (IRB 2019KY039) and was registered prior to patient enrollment at chictr.org.cn (ChiCTR1900024925) [ | PMC10483790 |
Patients | nasal malformation, mental illness, neurological diseases, nasal trauma | CHRONIC SINUSITIS, NEUROLOGICAL DISEASE, CARDIOVASCULAR DISEASE | Patients scheduled for FESS at the Shanghai General Hospital, China from September 18th, 2019 to December 16th, 2020 due to chronic sinusitis were screened for eligibility. Inclusion criteria were: age over 18 years old; American Society of Anesthesiologists Classification (ASA) class I–II with no serious cardiovascular disease; and normal preoperative liver and kidney function. Patients were excluded if they met the following criteria: ASA III-IV, severe cardiovascular disease, or poor blood pressure control; history of mental illness, neurological diseases, or usage of sedative or antipsychotic drug; nasal malformation, history of nasal trauma or implantation of nasal prosthesis. Written informed consent was obtained from all participants. | PMC10483790 |
Interventions | mouth-breathing, delirium | CAVITY, MUSCLE RELAXATION | Patients in preconditioning group underwent nasal splint preconditioning and mouth breath training in pre-anesthesia room 1 h before surgery. In details, a nasal splint (patent No. 202020982582.9, China) was used to clamp the subnasal cartilage in front of the nasal cavity to block breathing through nose (Fig.
A graphic summary displaying that preconditioning by nasal splint and mouth-breathing training reduces emergence delirium after FESSFor general anesthesia induction, all patients administrated midazolam (0.05 mg/kg), propofol (2 mg/kg), and sufentanil (0.25 µg/kg). Rocuronium(0.6 mg/kg) was then administered. After satisfactory muscle relaxation, tracheal intubation was carried out, followed by 60% O | PMC10483790 |
Outcomes | pain, Pain, hyperactive motor behavior | SECONDARY | Outcomes assessed followed the statements of previously published protocol [The main secondary outcome was the severity of ED, which was determined based on the presences of combative behavior, thrashing, and hyperactive motor behavior [Other secondary outcomes included intraoperative monitored parameters, such as duration of surgery, duration and dosage of anesthesia, usage of nasal package; as well as those recorded in post anesthesia care unit (PACU), including time to extubation, physical and biochemical characteristics when leaving PACU and length of hospital stay. Pain was assessed using Numerical Rating Scale (NRS) every 5 min immediately after extubation by a trained anesthesia nurse. A reassessed score of 4 or above indicated substantial pain, which was managed by an intravenous injection of 3–5 µg sufentanil. | PMC10483790 |
Sample size | RECRUITMENT | Based on the results from our pilot study, the incidence of ED after FESS was 21.3%. We assumed that the preconditioning would result in reduction of ED occurrence with an odds ratio (OR) of 1/3. At the setting of α = 0.05, an estimated sample size of 164 could provide a 90% of statistical power. Considering a potential dropout rate of 20%, 197 patients were required. Therefore, recruitment of 200 patients was planned. | PMC10483790 | |
Randomization and blinding | Random number sequence was generated by computer. Single-blind ED assessment was performed by an independent anesthesiologist who was not aware of the grouping information (started observation until after the removal of nasal clip) and a nurse anesthetist (Yuyu Gu) at PACU, with necessary consultation with the intraoperative anesthesiologist. | PMC10483790 | ||
Statistical analyses | REGRESSION, SECONDARY | According to the intention-to-treat principle, we used full analysis data set to analyze the primary outcome. The full analysis set (FAS), including all patients underwent randomization and at least once training and with once measurement after surgery, was used for analysis of primary and secondary outcome. Normal distributed continuous data were presented as mean ± standard deviation (SD), and difference between groups was tested by using student t-test. Skew-distributed data was presented as median and the 25th percentile and 75th percentile, and between-group differences were tested by using Mann-Whitney test. Categorical variables were described as number (n) and percentage (%) and chi-square test or Fisher’s exact test was used for comparisons between the two groups. Multivariable logistic regression model was performed to identify independent associated factors of ED. All statistical analyses were conducted by using IBM SPSS Statistics (Version 20.0, IBM, Armonk, NY, USA). Two-sided P-value less than 0.05 indicated statistical significance. | PMC10483790 | |
Results | delirium, SD, nasal obstruction | RECRUITMENT, HBP, DIABETES MELLITUS, REGRESSION, HIGH BLOOD PRESSURE | After screening of 232 patients, 200 met the inclusion and exclusion criteria and finally randomized. Among them, 18 patients were withdrawn (Fig.
Recruitment, randomization, and patient flow diagram of the trial. P-group, group with preconditioning of nasal splint and mouth breathing training; C-group, control groupThe median age of 182 patients was 51.5 years and 59.8% were male (Table
Baseline characteristics of patients between preconditioning group and control groupNote: Continuous data were presented as mean ± SD or median (the 25th percentile, the 75th percentile). Categorical variables were displayed in number (percentage). BMI: body mass index; MAP: mean arterial pressure; ASA: American Society of Anesthesiologists; HBP: high blood pressure; DM: diabetes mellitus; HR: heart rate; SpOThe incidence of ED in the preconditioning group was 16.30% (n = 15) and significantly lower than control group (n = 32, 35.56%, P = 0.004) (Table
Comparisons of outcomes between preconditioning group and control groupNote: Data were presented as median (IQR) or number (percentage). ED: emergence delirium; PACU: post-anesthesia care unit; NRS: numerical rating scale; HR: heart rate; MAP: mean arterial pressure; SpOA post-hoc sensitivity analysis identifying risk factors for ED was performed by using the univariate and multivariate models. After univariate models, we found totally 10 factors, including age, gender, BMI, smoking status, nasal obstruction with septum deviation, nasal splint, FESS with septoplasty, time to left PACU, medication use in PACU, and postoperative hospital stays, were significantly related with ED incidence (P < 0.05) (Table
Univariate analysis of potential associated factors of emergence deliriumNote: Continuous data were presented as mean ± SD or median (the 25th percentile, the 75th percentile). Categorical variables were displayed in number (percentage). ED: emergence delirium; BMI: body mass index; MAP: mean arterial pressure; ASA: American Society of Anesthesiologists; HBP: high blood pressure; DM: diabetes mellitus; HR: heart rate; SpO
Multivariate logistic regression analysis of independent associated variables of emergence deliriumNote: OR, odds ratio; 95% CI, 95% confidence interval; BMI, body mass index | PMC10483790 |
Discussion | blindness, throat, postoperative agitation, agitation, mouth-breathing | BLINDNESS | This randomized controlled trial showed that preconditioning with nasal splint and mouth-breathing training preparation significantly decreased the incidence of ED after FESS by more than 50%. The intraoperative sufentanil dosage of the preconditioning group was significantly improved by 20.0 µg. Post-hoc analysis suggested that patients with ED required more postoperative hospital stay, and younger, males, with smoking status, with FESS with septoplasty, with aasal septum deviation with obstruction and without nasal splint were more likely to present ED.Otorhinolaryngology operations, or surgeries involving the ear, nose, and throat (ENT), were reported to be associated with increased risks of postoperative agitation and ED [The identified incidence of ED in this study was 25.8%, which was consistent with the previously evidence. For example, a retrospective study reviewing 792 adults who underwent general anesthesia for nasal surgery reported the overall incidence of emergence agitation at 22.2% [This randomized trial potentially balanced many baseline characteristics and preoperative parameters between two groups; however, the occurrence of ED could be influenced by numerous unknown factors. For example, the intraoperative dosage of sufentanil was significantly higher in preconditioning group than that in the control group. To further eliminate the possibility that the observed difference in ED incidence was due to differences in other factors rather than the preconditioning treatment, we applied a post-hoc case-control analysis to confirmed the independent risk factors of ED. Our results identified age, gender, smoking, FESS with septoplasty and surgery category were independent risk factors of ED, which were consistent from previous evidences [There were several limitations in this study. Firstly, the study was a single center study with relatively limited samples size, hence our conclusion might not be stable and extension of our conclusion to other patients should be verified in further multi-center or multi-regional, well-designed, large-scaled randomized trials. Secondly, in this study the identification of ED mainly depended on the subjective assessment from physicians based on the postoperative evens and intraoperative signs. Also, the blindness of intervention for intraoperative anesthesiologist could not be achieved. All these might raise the uncontrolled bias for outcome assessment and introduced the misclassification bias. More objective evaluation of ED by anesthesiologist and nurse with blindness at PACU was necessary. Thirdly, although this is a drug-free intervention and had almost no side effects, this study did not include a positive parallel control to eliminate the non-drug modality with pharmacological treatment (e.g., dexmedetomidine) [ | PMC10483790 |
Acknowledgements | Not applicable. | PMC10483790 | ||
Author contributions | H.X. contributed to drafting of the manuscript. Z.S. contributed to data curation. Y.G. contributed to supervision. Y.H. contributed to data collection. J.J., X.L. and M.Z. contributed to the operation of the study. Y.Z. contributed to statistical analysis. J.L. contributed to study design and reviewing of the manuscript. All authors have read and approved the final manuscript. | PMC10483790 | ||
Funding | This study was supported by Clinical Research Innovation Plan of Shanghai General Hospital [grant number: KD031-ly01to Jinbao Li, CNY 600,000; CTCCR-2021C21 to Hongjiao Xu, CNY 50,000]. The funding only gave financial support. | PMC10483790 | ||
Data Availability | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10483790 | ||
Declarations | PMC10483790 | |||
Competing interests | The authors declare no competing interests. | PMC10483790 | ||
Ethics approval and consent to participate | The study was conducted according to the Declaration of Helsinki and study protocol was approved by the Shanghai General Hospital Institutional Review Board (IRB 2019KY039). Written informed consent to participate was obtained from participants. | PMC10483790 | ||
Consent for publication | Not applicable. | PMC10483790 | ||
Abbreviations | American Society of Anesthesiologists Classificationemergence deliriumfrequencyFunctional Endoscopic Sinus Surgeryheart rateinterquartile rangeminimum alveolar concentrationnon-invasive blood pressureNumerical Rating Scaleodds ratiopost-anesthesia care unitstandard deviationOxygen saturationtidal volume | PMC10483790 | ||
References | PMC10483790 | |||
Purpose | hip arthroplasty, femoral cutaneous nerve, THA, postoperative pain | To assess the efficacy of pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve (LFCN) block in controlling postoperative pain and promoting recovery of lower extremity after total hip arthroplasty (THA), and to compare its effectiveness with supra-inguinal fascia iliaca compartment block (S-FICB). | PMC10390614 | |
Materials and methods | LFCN block | 92 patients undergoing THA with general anesthesia were randomly allocated to receive either a PENG with LFCN block ( | PMC10390614 | |
Results | The combination of PENG with LFCN blocks resulted in an earlier first postoperative walking time (19.6 ± 9.6 h vs 26.5 ± 8.2 h, | PMC10390614 | ||
Conclusions | PENG with LFCN blocks is more effective than S-FICB in shortening the time to first postoperative walk and preservation hip motion after THA, which makes it a suitable addition to enhanced recovery programs following surgery. | PMC10390614 |
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