scholarly journals Comparison of three different exercise training modalities (aerobic, strength and mixed) in patients with schizophrenia: study protocol for a multicentre randomised wait-list controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e046216
Author(s):  
Laura García-Garcés ◽  
Sergio Lacamara Cano ◽  
Yago Cebolla Meliá ◽  
María I Sánchez-López ◽  
David Marqués Azcona ◽  
...  

IntroductionNumerous studies support the practice of different physical exercise modalities as an effective treatment to address the problems associated with schizophrenia, reporting that they result in improvements in patient symptoms and quality of life. Given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programmes (strength, aerobic and mixed) on the symptoms, body composition, level of physical activity and health-related quality of life of patients with schizophrenia.Methods and analysisA multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting 1 hour each, or to the wait-list control group. The training groups will complete aerobic, strength or mixed (aerobic+strength) training. The participants will be assessed before, immediately after and 6 months after the end of the intervention. The patients in the wait-list control group (n=15) will receive one of the three trainings immediately after the intervention. The study variables will include positive, negative and general symptomology (Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form) and quality of life (abbreviated WHO Quality of Life questionnaire).Ethics and disseminationThis study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia, Spain (CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.Trial registration numberNCT04987151.

2021 ◽  
Vol 26 ◽  
pp. 2515690X2199199
Author(s):  
Suprakash Mandal ◽  
Puneet Misra ◽  
Gautam Sharma ◽  
Rajesh Sagar ◽  
Shashi Kant ◽  
...  

Background. Nursing staff suffer from various level of stress and burnout. We aimed to assess the effect of 12 weeks of structured yoga on stress and the professional quality of life among nursing staff. Design and method. An open-label, phase-II randomized clinical trial was undertaken considering a sample size of convenience was done. In service nursing staff were randomized (1:1) to intervention group and wait-list control group. Primary outcome was perceived stress which was measured by Perceived Stress Scale (PSS). Secondary measures were professional quality measured by Professional Quality of Life (ProQOL) scale, blood pressure, serum cortisol, and high-sensitive C-reactive protein. Both the per-protocol and intention to treat analysis was done. Results. Total 113 participants were allocated to intervention group (n = 58, mean = 35 years, SD = 7.9 years) and wait-list control group (n = 55, mean = 32.5 years, SD = 6.8 years). After 12 weeks, 19 participants of intervention group and 32 participants of wait-list control group were included in the per-protocol analysis. Follow-up mean PSS score was 15.4 (95% CI 12.6-18.2, SD 5.8) in intervention group, 20.7 (95% CI 19.7-21.7, SD 2.8) in wait-list control group (p-value < 0.0001). The other parameters didn’t differ between the groups and from baseline to end line too. Conclusions and relevance. The finding showed supervised structured yoga may be efficacious to reduce stress. Studies with larger sample size are needed to confirm the findings. Trial registration. It was approved by the Institute Ethics Committee (Reference no: IECPG-543/20.12.2017, RT-57/31.01.2018) and was registered prospectively in the Clinical Trial Registry of India prospectively (No. CTRI/2018/02/012206).


Children ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. 76
Author(s):  
Emma S. Cowley ◽  
Paula M. Watson ◽  
Lawrence Foweather ◽  
Sarahjane Belton ◽  
Chiara Mansfield ◽  
...  

Background. This is a formative evaluation study of the HERizon Project, a home-based multi-component physical activity (PA) intervention for adolescent girls in the UK and Ireland. Although not intended, this study coincided with the initial COVID-19 lockdown restrictions. Methods. A total of 42 female participants, aged 13 to 16 years old (mean = 14.2, SD = 1.1), were randomly allocated to: (i) the HERizon group (n = 22) or (ii) the wait-list control group (n = 20). Participants in the six-week HERizon group were asked to complete three PA sessions each week and engage in weekly behaviour change support video calls. The primary outcome measure was self-reported habitual PA. Secondary outcomes measures included cardiorespiratory fitness (20 m shuttle run), muscular strength (standing long jump), muscular endurance (push up test), and psychosocial outcomes (Perceived Competence Scale, Body Appreciation Scale, Self-Esteem Questionnaire, Behavioural Regulation in Exercise Questionnaire). Quantitative and qualitative process evaluation data were also collected. Outcome measures were assessed at baseline and after the six-week intervention. Results. There was no significant change in habitual PA between groups (LMM group*time interaction: p = 0.767). The HERizon group had significantly increased cardiorespiratory fitness (p = 0.001), muscular endurance (p = 0.022), intrinsic motivation (p = 0.037), and body appreciation (p < 0.003) in comparison to the wait-list control group. All participants in the intervention group completed the intervention and compliance to the intervention was high (participants completed 18 ± 2 sessions). Conclusions. Although no change in PA was observed, HERizon resulted in improved physical fitness and psychosocial outcomes. These preliminary findings, alongside positive findings for feasibility and acceptability, highlight potential benefits from the home-based intervention, thus further investigation is warranted.


Author(s):  
Nicola D. Ridgers ◽  
Anna Timperio ◽  
Kylie Ball ◽  
Samuel K. Lai ◽  
Helen Brown ◽  
...  

Abstract Background There has been increasing interest in using wearable activity trackers to promote physical activity in youth. This study examined the short- and longer-term effects of a wearable activity tracker combined with digital behaviour change resources on the physical activity of adolescents attending schools in socio-economically disadvantaged areas. Methods The Raising Awareness of Physical Activity (RAW-PA) Study was a 12-week, multicomponent intervention that combined a Fitbit Flex (and accompanying app), and online digital behaviour change resources and weekly challenges delivered via Facebook. RAW-PA was evaluated using a cluster-randomised controlled trial with 275 adolescents (50.2% female; 13.7 ± 0.4 years) from 18 Melbourne secondary schools (intervention n = 9; wait-list control group n = 9). The primary outcome was moderate- to vigorous-intensity physical activity (MVPA), measured using hip-worn ActiGraph accelerometers. The secondary outcome was self-reported physical activity. Data were collected at baseline, 12-weeks (immediately post-intervention), and 6-months post-intervention (follow-up). Multilevel models were used to determine the effects of the intervention on daily MVPA over time, adjusting for covariates. Results No significant differences were observed between intervention and wait-list control adolescents’ device-assessed MVPA immediately post-intervention. At 6-months post-intervention, adolescents in the intervention group engaged in 5 min (95% CI: − 9.1 to − 1.0) less MVPA per day than those in the wait-list control group. Males in the intervention group engaged in 11 min (95% CI: − 17.6 to − 4.5) less MVPA than males in the wait-list control group at 6-months post-intervention. No significant differences were observed for females at either time point. For self-reported physical activity, no significant effects were found at 12-weeks and 6-months post-intervention. Conclusions Combining a wearable activity tracker with digital behaviour change resources and weekly challenges did not increase inactive adolescents’ accelerometer-derived and self-reported physical activity levels immediately post-intervention. This contrasts previous research that has suggested wearable activity tracker may increase youth physical activity levels in the short-term. Lower engagement in MVPA 6-months post-intervention was observed for males but not for females, though it is unclear why this finding was observed. The results suggest wearable activity trackers, in combination with supporting materials, may not be effective for increasing physical activity levels in adolescents. Trial registration ACTRN12616000899448. Australian and New Zealand Clinical Trials Registry. Registered 7 July 2016.


2000 ◽  
Vol 34 (5) ◽  
pp. 809-813 ◽  
Author(s):  
Stephen Halperin ◽  
Paula Nathan ◽  
Peter Drummond ◽  
David Castle

Objective: The objective of this study was to investigate the efficacy of group-based cognitive-behavioural therapy (CBT) for social anxiety in schizophrenia. Method: Patients with schizophrenia (20) with comorbid social anxiety were randomly assigned to the group-based CBT or wait-list control condition. Pre-, post- and 6-week follow-up ratings included measures of social anxiety and avoidance, mood and quality of life. Results: The intervention group improved on all outcome measures and the control group showed no change in symptomatology. Conclusions: Group-based CBT is effective in treating social anxiety in schizophrenia.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1405.1-1405
Author(s):  
R. De Oliveira ◽  
P. Julio ◽  
P. Fernandes ◽  
R. Marini ◽  
S. Appenzeller

Background:With improvement of treatment, long-term factors influencing quality of life have to be addressed in the care of juvenile idiopathic arthritis (JIA) patients.Objectives:To compare body composition, level of physical activity and self-esteem of adult patients with JIA with control group (CG).Methods:The levels of physical activity were analyzed using the International Physical Activity Questionnaire (IPAQ) short version. The body composition data were collected using the Omrom HBF 514 C vertical electric bioimpedance device. The Rosenberg Self-Esteem Scale was used to assess positive and negative attitude and feelings about themselves, where the lower the score, the higher the individual’s self-esteem. For the statistical analysis of the data, the IBM SPSS software was used with a significance index of p <0.05.Results:We included 81 individuals >18 years, 38 with JIA and 43 healthy people. The female sex was the largest participant in this research, being. There was no significant difference regarding sex [female =28 (73.7%) in JIA and 26 (60.5%) in CG] and age of the groups (29.39 ± 7.6 vs. 31.1 ± 3.1, p = 0.18). The CG showed greater height and body weight (163.5 ± 9.8 vs. 169.6 ± 8.0, p<0.001; 63.07 ± 16.65 vs. 69.33 ± 6.88, p = 0.003, respectively), but no difference in Body Mass Index (BMI) was observed (24.32 ± 4.9 vs. 24.12 ± 2.09, p = 0.8). JIA had a higher percentage of total fat mass (31.65 ± 10.20 vs. 28.47 ± 4.9, p = 0.07), while the CG had a higher percentage of total muscle mass (29.7 ± 6.5 vs. 35.86 ± 6.05, p<0.001). The self-esteem of JIA patients was lower than in the CG (21 ± 3.9 vs. 16.26 ± 4.3, p<0.001). In the IPAQ classifications, JIA patients were classified as less physically active than the CG (2.63% vs. 20.93%, p = 0.022), less irregularly active (5.26% vs. 23.25, p = 0.023) and a higher level of sedentary lifestyle (65.78% vs. 25.58%, p<0.001). A higher percentage of muscle mass was associated with greater self-esteem (r=-0.3; p=0.01).Conclusion:The low practice of physical activities by patients with JIA seems to directly influence both, their body composition and their self-esteem. These patients should be encouraged to increase physical activity from an early age by a multiprofessional healthcare team to seek improvement their quality of life.Disclosure of Interests:None declared


Medicina ◽  
2021 ◽  
Vol 57 (2) ◽  
pp. 122
Author(s):  
Marta Pérez-Rodríguez ◽  
Saleky García-Gómez ◽  
Javier Coterón ◽  
Juan José García-Hernández ◽  
Javier Pérez-Tejero

Background and objectives: Acquired brain injury (ABI) is the first cause of disability and physical activity (PA) is a key element in functional recovery and health-related quality of life (HRQoL) during the subacute and chronic phases. However, it is necessary to develop PA programs that respond to the heterogeneity and needs of this population. The aim of this study was to assess the effectiveness of a PA program on the HRQoL in this population. Materials and Methods: With regard to recruitment, after baseline evaluations, participants were assigned to either the intervention group (IG, n = 38) or the control group (CG, n = 35). Functional capacity, mood, quality of life and depression were measured pre- and post-intervention. The IG underwent the “Physical Activity and Sport for Acquired Brain Injury” (PASABI) program, which was designed to improve HRQoL (1-h sessions, two to four sessions/week for 18 weeks). The CG underwent a standard rehabilitation program without PA. Results: Results for the IG indicated significant differences and large effect sizes for the physical and mental dimensions of quality of life, as well as mood and functional capacity, indicating an increase in HRQoL. No significant differences were found for the CG across any variables. Conclusions: The PASABI program was feasible and beneficial for improving physiological and functionality variables in the IG. The wide range of the activities of the PASABI program allow its application to a large number of people with ABI, promoting health through PA, especially in the chronic phase.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Leonessa Boing ◽  
Tatiana do Bem Fretta ◽  
Melissa de Carvalho Souza Vieira ◽  
Gustavo Soares Pereira ◽  
Jéssica Moratelli ◽  
...  

Abstract Background Breast cancer is a global public health issue. The side effects of the clinical treatment can decrease the quality of life of these women. Therefore, a healthy lifestyle is essential to minimize the physical and psychological side effects of treatment. Physical activity has several benefits for women with breast cancer, and Pilates solo and belly dancing can be an enjoyable type of physical activity for women with breast cancer undergoing clinical treatment. The purpose of this study is to provide a Pilates solo and a belly dance protocol (three times per week/16 weeks) for women undergoing breast cancer treatment and compare its effectiveness with that in the control group. Methods The participants will be allocated to either the intervention arm (Pilates solo or belly dance classes three times per week for 16 weeks) or a control group (receipt of a booklet on physical activity for patients with breast cancer and maintenance of habitual physical activity routine). The Pilates solo and belly dance classes will be divided into three stages: warmup and stretching, the main stage, and relaxation. Measurements of the study outcomes will take place at baseline; postintervention; and 6, 12, and 24 months after the end of the intervention (maintenance period). The data collection for both groups will occur with a paper questionnaire and tests covering general and clinical information. The primary outcome will be quality of life (EORT QLQ-C30 and EORT QLQ-BR23), and secondary outcomes will be physical aspects such as cardiorespiratory fitness (6-min walk test and cycle ergometer), lymphedema (sum of arm circumference), physical activity (IPAQ short version), disabilities of the arm (DASH), range of motion (goniometer test), muscular strength (dynamometer test) and flexibility (sit and reach test), and psychological aspects such as depressive symptoms (Beck Depression Inventory), body image (Body Image After Breast Cancer Questionnaire), self-esteem (Rosenberg), fatigue (FACT-F), pain (VAS), sexual function (FSFI), and sleep quality (Pittsburgh Sleep Quality Index). Discussion In view of the high prevalence of breast cancer among women, the implementation of a specific protocol of Pilates solo and belly dancing for patients with breast cancer is important, considering the necessity to improve their physical and psychological quality of life. Pilates solo and belly dancing are two types of physical activity that involve mental and physical concentration, music, upper limb movements, femininity, and social involvement. An intervention with these two physical activities could offer options of supportive care to women with breast cancer undergoing treatment, with the aim being to improve physical and psychological quality of life. Trial registration ClinicalTrials.gov, NCT03194997. Registration date 12 August 2017. Universal Trial Number (World Health Organization), U1111-1195-1623.


2021 ◽  
pp. 136749352110037
Author(s):  
Alison E. Parker ◽  
Tracy M. Scull ◽  
Abigail M. Morrison

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.


2021 ◽  
Author(s):  
Florie FILLOL ◽  
Ludivine PARIS ◽  
Sébastien PASCAL ◽  
Aurélien MULLIEZ ◽  
Christian-François ROQUES ◽  
...  

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.


Sign in / Sign up

Export Citation Format

Share Document