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"Exercise Research Statistical methods."
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Aerobic endurance training to improve cognition and enhance recovery in schizophrenia: design and methodology of a multicenter randomized controlled trial
by
Meyer-Lindenberg, Andreas
,
Schneider-Axmann, Thomas
,
Lembeck Moritz
in
Cardiovascular diseases
,
Clinical trials
,
Cognition & reasoning
2021
Even today, patients with schizophrenia often have an unfavorable outcome. Negative symptoms and cognitive deficits are common features in many patients and prevent recovery. In recent years, aerobic endurance training has emerged as a therapeutic approach with positive effects on several domains of patients’ health. However, appropriately sized, multicenter randomized controlled trials that would allow better generalization of results are lacking. The exercise study presented here is a multicenter, rater-blind, two-armed, parallel-group randomized clinical trial in patients with clinically stable schizophrenia being conducted at five German tertiary hospitals. The intervention group performs aerobic endurance training on bicycle ergometers three times per week for 40–50 min/session (depending on the intervention week) for a total of 26 weeks, and the control group performs balance and tone training for the same amount of time. Participants are subsequently followed up for 26 weeks. The primary endpoint is all-cause discontinuation; secondary endpoints include psychopathology, cognition, daily functioning, cardiovascular risk factors, and explorative biological measures regarding the underlying mechanisms of exercise. A total of 180 patients will be randomized. With currently 162 randomized participants, our study is the largest trial to date to investigate endurance training in patients with schizophrenia. We hypothesize that aerobic endurance training has beneficial effects on patients’ mental and physical health, leading to lower treatment discontinuation rates and improving disease outcomes. The study results will provide a basis for recommending exercise interventions as an add-on therapy in patients with schizophrenia.The study is registered in the International Clinical Trials Database (ClinicalTrials.gov identifier [NCT number]: NCT03466112) and in the German Clinical Trials Register (DRKS-ID: DRKS00009804).
Journal Article
Self-monitoring and reminder text messages to increase physical activity in colorectal cancer survivors (Smart Pace): a pilot randomized controlled trial
by
Paciorek, Alan
,
Mitchell, Emily
,
Zhang, Li
in
Accelerometer
,
Accelerometers
,
Accelerometry - methods
2019
Background
Over 1.3 million people live with colorectal cancer in the United States. Physical activity is associated with lower risk of colorectal cancer recurrence and mortality. Interventions are needed to increase physical activity in colorectal cancer survivors.
Methods
We conducted a 2-arm non-blinded pilot randomized controlled trial at the University of California, San Francisco among 42 individuals who had completed curative-intent treatment for colorectal cancer to determine the feasibility and acceptability of a 12-week (84 days) physical activity intervention using a Fitbit Flex™ and daily text messages. Participants were randomized 1:1 to receive the intervention with print educational materials or print educational materials alone. We explored the impact of the intervention versus usual care on physical activity using ActiGraph GT3X+ accelerometers pre−/post-intervention.
Results
We screened 406 individuals and randomized 42 to intervention (
n
= 21) or control (
n
= 21) groups. During the 12-week study, the intervention arm wore their Fitbits a median of 74 days [88% of days in study period, interquartile range: 23–83 days] and responded to a median of 34 (out of 46) text messages that asked for a reply (interquartile range: 13–38 text messages). Among the 16 intervention participants who completed the feedback survey, the majority (88%) reported that the intervention motivated them to exercise and that they were satisfied with their experience. No statistically significant difference in change in moderate-to-vigorous physical activity was found from baseline to 12 weeks between arms.
Conclusion
A 12-week physical activity intervention with a Fitbit and text messages was feasible and acceptable among colorectal cancer patients after curative treatment. Larger studies are needed to determine whether the intervention increases physical activity.
Trial registration
Clinicaltrials.gov
Identifier
NCT02966054
. Registered 17 November 2016, retrospectively registered.
Journal Article
Feasibility of preoperative supervised home-based exercise in older adults undergoing colorectal cancer surgery – A randomized controlled design
by
Karlsson, Emelie
,
Rydwik, Elisabeth
,
Franzén, Erika
in
Acceptability
,
Aged
,
Aged, 80 and over
2019
Preoperative physical exercise is emerging as a growing field of research globally. There are still challenges in recruiting vulnerable older people, and time constraints in preoperative cancer care to consider. We therefore evaluated the feasibility of short-term supervised home-based exercise in older people prior to colorectal cancer surgery. This feasibility study was conducted between September 2016 and June 2018. People ≥70 years scheduled for colorectal cancer surgery were recruited and randomized to an intervention group receiving supervised home-based physical exercise at a high level of estimated exertion or a standard care group following the standard preoperative path. The exercise (respiratory, strength, and aerobic) consisted of 2-3 supervised sessions a week in the participants' homes, for at least 2-3 weeks or until surgery, and a self-administered exercise program in between. The primary outcome was process feasibility, including aspects specifically related to recruitment rate, compliance to the intervention, and acceptability. The secondary outcome was scientific feasibility including treatment safety, description of dose level and response, and estimation of treatment results. Twenty-three participants were included (recruitment rate 35%). A median of 6 supervised sessions was conducted over a 17-day exercise period. Compliance with the supervised sessions was 97%, and participants found the intervention acceptable. Concerning the self-administered exercise, a median of 19 inspiratory muscle training, 6 functional strength, and 8.5 aerobic sessions were reported. Challenges reported by program instructors were time constraints and difficulties in achieving high exercise intensities on the Borg CR-10 scale. A statistically significant between-group difference was only found in inspiratory muscle strength, favoring the intervention group (p<0.01). A short-term preoperative supervised home-based physical exercise intervention can be conducted, with respect to compliance and acceptability, in older people with similar physical status as in this study prior to colorectal cancer surgery. However, modifications are warranted with respect to improving recruitment rates and achieving planned intensity levels prior to conducting a definitive trial.
Journal Article
Implementing the 27 PRISMA 2020 Statement items for systematic reviews in the sport and exercise medicine, musculoskeletal rehabilitation and sports science fields: the PERSiST (implementing Prisma in Exercise, Rehabilitation, Sport medicine and SporTs science) guidance
by
Moher, David
,
Wright, Alexis A
,
Büttner, Fionn
in
Consensus Statement
,
Decision making
,
Evaluation
2022
Poor reporting of medical and healthcare systematic reviews is a problem from which the sports and exercise medicine, musculoskeletal rehabilitation, and sports science fields are not immune. Transparent, accurate and comprehensive systematic review reporting helps researchers replicate methods, readers understand what was done and why, and clinicians and policy-makers implement results in practice. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement and its accompanying Explanation and Elaboration document provide general reporting examples for systematic reviews of healthcare interventions. However, implementation guidance for sport and exercise medicine, musculoskeletal rehabilitation, and sports science does not exist. The Prisma in Exercise, Rehabilitation, Sport medicine and SporTs science (PERSiST) guidance attempts to address this problem. Nineteen content experts collaborated with three methods experts to identify examples of exemplary reporting in systematic reviews in sport and exercise medicine (including physical activity), musculoskeletal rehabilitation (including physiotherapy), and sports science, for each of the PRISMA 2020 Statement items. PERSiST aims to help: (1) systematic reviewers improve the transparency and reporting of systematic reviews and (2) journal editors and peer reviewers make informed decisions about systematic review reporting quality.
Journal Article
Cognitive and physical impact of combined exercise and cognitive intervention in older adults with mild cognitive impairment: A systematic review and meta-analysis
2024
Emerging studies have examined the effectiveness of combined exercise and cognitive intervention (combined intervention) on the cognitive function of older adults with MCI, but the conclusions remain disputed. Our study aimed to comprehensively examine the efficacy of the combined intervention on cognitive and physical function in older adults with MCI. PubMed, Cochrane Library, EMBASE, and PsycINFO were retrieved to identify the relevant articles. Twelve eligible studies were included, and the results showed that combined intervention significantly improved global cognition SMD = 0.26, 95% CI [0.14-0.39], p <0.0001), executive function (SMD = 0.40, 95% CI [0.25-0.56], p < 0.00001), memory (SMD = 0.30, 95% CI [0.22-0.39], p <0.00001), and gait performance (SMD = 0.32, 95% CI [0.03-0.62], P = 0.03) compared to the control group. Combined intervention significantly improved executive function compared to single exercise intervention while not showing a statistically significant difference compared to single cognitive intervention. Moreover, no significant difference was observed between simultaneously and sequentially combined intervention. The finding indicated that combined intervention is efficacious in improving global cognition and selectively enhancing cognitive domains and physical function in older adults with MCI. More research with robust designs should be conducted, particularly involving comparisons with single interventions and different types of combined interventions.
Journal Article
Effects of Exercise and Nutritional Intervention on Body Composition, Metabolic Health, and Physical Performance in Adults with Sarcopenic Obesity: A Meta-Analysis
2019
People with sarcopenic obesity (SO) are characterized by both low muscle mass (sarcopenia) and high body fat (obesity); they have greater risks of metabolic diseases and physical disability than people with sarcopenia or obesity alone. Exercise and nutrition have been reported to be effective for both obesity and sarcopenia management. Thus, we aimed to investigate the effects of exercise and nutrition on body composition, metabolic health, and physical performance in individuals with SO. Studies investigating the effects of exercise and nutrition on body composition, metabolic health, and physical performance in SO individuals were searched from electronic databases up to April 2019. Fifteen studies were included in the meta-analysis. Aerobic exercise decreased body weight and fat mass (FM). Resistance exercise (RE) decreased FM and improved grip strength. The combination of aerobic exercise and RE decreased FM and improved walking speed. Nutritional intervention, especially low-calorie high-protein (LCHP) diet, decreased FM but did not affect muscle mass and grip strength. In addition to exercise training, nutrition did not provide extra benefits in outcome. Exercise, especially RE, is essential to improve body composition and physical performance in individuals with SO. Nutritional intervention with LCHP decreases FM but does not improve physical performance.
Journal Article
Fidelity, pragmatism and the “grey line” in between—exploring the delivery of a pragmatic physical activity randomised controlled trial—a secondary analysis
by
Hall, Abigail J.
,
Clarke, David J.
,
Goodwin, Victoria A.
in
Aged
,
Analysis
,
Beliefs, opinions and attitudes
2024
Background
Intervention fidelity in health services research has been poor with a reported lack of understanding about what constitutes pragmatic adaptation of interventions and what constitutes failure to maintain intervention fidelity. However, the challenges facing those delivering such interventions have not been thoroughly explored.
The aims of this study were to critically explore the challenges in maintaining fidelity experienced by physiotherapy staff and support workers when delivering a complex intervention for older people living with frailty.
Methods
This study is a secondary analysis of data from a process evaluation of a large randomised controlled trial (RCT). The process evaluation employed qualitative methodologies with mixed methods including a variety of data collection methods, including participant observation, semi-structured interviews and documentary analysis. Thematic analysis was used to make sense of the data.
Results
Many therapy staff felt ongoing confusion about what was acceptable to adapt and what needed to follow the protocol exactly. We found that some therapy staff were able to embrace the challenges of pragmatically adapting interventions while maintaining intervention fidelity, others stuck rigidly to the protocol and failed to adapt interventions where it was necessary.
Conclusion
It was clear that the understanding of fidelity and pragmatism was poor. While pragmatic trials are vital to replicate real world clinical practice, further guidance may need to be developed in order to guide the level of adaptation that is acceptable before fidelity is undermined.
Journal Article
Effect of four different forms of high intensity training on BDNF response to Wingate and Graded Exercise Test
by
Murawska-Ciałowicz, Eugenia
,
Stastny, Petr
,
Clemente, Filipe Manuel
in
631/337
,
631/378
,
631/443
2021
This study examined the effects of a nine-week intervention of four different high-intensity training modalities [high-intensity functional training (HIFT), high-intensity interval training (HIIT), high-intensity power training (HIPT), and high-intensity endurance training (HIET)] on the resting concentration of brain-derived neurotropic factor (BDNF). In addition, we evaluated the BDNF responses to Graded Exercise Test (GXT) and Wingate Anaerobic Test (WAnT) in men. Thirty-five healthy individuals with body mass index 25.55 ± 2.35 kg/m
2
voluntarily participated in this study and were randomly assigned into four training groups. During nine-weeks they completed three exercise sessions per week for one-hour. BDNF was analyzed before and after a GXT and WAnT in two stages: (stage 0—before training and stage 9—after nine weeks of training). At stage 0, an increase in BDNF concentration was observed in HIFT (33%; p < 0.05), HIPT (36%; p < 0.05) and HIIT (38%; p < 0.05) after GXT. Even though HIET showed an increase in BDNF (10%) this was not statistically significant (p > 0.05). At stage 9, higher BDNF levels after GXT were seen only for the HIFT (30%; p < 0.05) and HIIT (18%; p < 0.05) groups. Reduction in BDNF levels were noted after the WAnT in stage 0 for HIFT (− 47%; p < 0.01), HIPT (− 49%; p < 0.001), HIET (− 18%; p < 0.05)], with no changes in the HIIT group (− 2%). At stage 9, BDNF was also reduced after WAnT, although these changes were lower compared to stage 0. The reduced level of BDNF was noted in the HIFT (− 28%; p < 0.05), and HIPT (− 19%;p < 0.05) groups. Additionally, all groups saw an improvement in VO
2max
(8%; p < 0.001), while BDNF was also correlated with lactate and minute ventilation and selected WAnT parameters. Our research has shown that resting values of BDNF after nine weeks of different forms of high-intensity training (HIT) have not changed or were reduced. Resting BDNF measured at 3th (before GXT at stage 9) and 6th day after long lasting HITs (before WAnT at stage 9) did not differed (before GXT), but in comparison to the resting value before WAnT at the baseline state, was lower in three groups. It appears that BDNF levels after one bout of exercise is depended on duration time, intensity and type of test/exercise.
Journal Article
A systematic review and meta-analysis of adherence to physical activity interventions among three chronic conditions: cancer, cardiovascular disease, and diabetes
2019
Background
Physical activity is effective for the prevention and treatment of chronic disease, yet insufficient evidence is available to make comparisons regarding adherence to aerobic physical activity interventions among chronic disease populations, or across different settings.
The purpose of this review is to investigate and provide a quantitative summary of adherence rates to the aerobic physical activity guidelines among people with chronic conditions, as physical activity is an effective form of treatment and prevention of chronic disease.
Methods
Randomized controlled (RCTs) trials where aerobic physical activity was the primary intervention were selected from PsychInfo, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Clinical Key, and SCOPUS from 2000 to 2018. Studies were included if the program prescription aligned with the 2008 aerobic physical activity guidelines, were at least 12 weeks in length, and included adult participants living with one of three chronic diseases. The data was extracted by hand and the PRISMA (preferred reporting items for systematic review and meta-analysis) guidelines were used to evaluate risk-of-bias and quality of evidence. Data were pooled using random-effect models. The primary outcome measure was program adherence and the secondary outcome measures were dropout and setting (e.g. home vs. clinic-based). Pooled effect sizes and 95% CiIs (confidence intervals) were calculated using random-effect models.
Results
The literature search identified 1616 potentially eligible studies, of which 30 studies (published between 2000 and 2018, including 3,721 participants) met the inclusion criteria. Three clinical populations were targeted: cancer (
n
= 14), cardiovascular disease (
n
= 7), and diabetes (
n
= 9). Although not statistically significant, adherence rates varied across samples (65, 90, and 80%, respectively) whereas dropout rates were relatively low and consistent across samples (5, 4, and 3%). The average adherence rate, regardless of condition, is 77% (95% CI = 0.68, 0.84) of their prescribed physical activity treatment. The pooled adherence rates for clinic-based and home-based programs did not differ (74% [95% CI, 0.65, 0.82] and 80% [95% CI, 0.65, 0.91], respectively).
Conclusions
The current evidence suggests that people with chronic conditions are capable of sustaining aerobic physical activity for 3+ months, as a form of treatment. Moreover, home-based programs may be just as feasible as supervised, clinic-based physical activity programs.
Journal Article