Supervised Exercise Immediately After Bariatric Surgery: the Study Protocol of the EFIBAR Randomized Controlled Trial.
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ABSTRACT: Background
Previous studies have investigated weight loss caused by exercise following bariatric surgery. However, in most cases, the training program is poorly reported; the exercise type, volume, and intensity are briefly mentioned; and the sample size, selection criteria, and follow-up time vary greatly across studies.Purpose
The EFIBAR study aims to investigate over 1 year the effects of a 16-week supervised exercise program, initiated immediately after bariatric surgery, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, and quality of life in patients with severe/extreme obesity.Material and methods
The EFIBAR study is a parallel-group, superiority, randomized controlled trial (RCT), comprising 80 surgery patients. Half of the participants, randomly selected, perform a 16-week supervised exercise program, including both strength and aerobic training, starting immediately after the surgery (7-14 days). For each participant, all primary and secondary outcomes are measured at three different time points: (i) before the surgery, (ii) after the intervention (≈4 months), and (iii) 1 year after the surgery.Conclusion
The EFIBAR study will provide new insights into the multidimensional benefits of exercise in adults with severe/extreme obesity following bariatric surgery.Trial registration
EFIBAR randomized controlled trial was prospectively registered at Clinicaltrials.gov (NCT03497546) on April 13, 2018.
SUBMITTER: Artero EG
PROVIDER: S-EPMC8458203 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThere is increasing evidence of weight regain in patients after bariatric surgery (BS), generally occurring from 12 to 24 months postoperatively. Postoperative exercise has been suggested to ad long-term weight maintenance and to improve physical function in BS patients. However, there are a limited number of intervention studies investigating the possible benefits of exercise in this population. The aim of the current report is to provide a comprehensive CERT (Consensus on Exercise Reporting Template)-based description of the rationale and details of the exercise programme implemented in the EFIBAR Study (Ejercicio FÍsico tras cirugía BARiátrica), a randomised controlled trial investigating the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, physical activity and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery.MethodsA total of 80 BS patients [60-80% expected women, aged 18 to 60 years, body mass index (BMI) ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbid conditions)] will be enrolled in the EFIBAR Randomized Control Trial (RCT). Participants allocated in the exercise group (n = 40) will undertake a 16-week supervised concurrent (strength and aerobic) exercise programme (three sessions/week, 60 min/session), starting 7 to 14 days after surgery. The rationale of the exercise programme will be described following the CERT criteria detailing the 16 key items. The study has been reviewed and approved by the Ethics Committee of the Torrecárdenas University Hospital (Almería, Spain) (ref. N° 76/2016).DiscussionThe present study details the exercise programme of the EFIBAR RCT, which may serve: 1) exercise professionals who would like to implement an evidence-based exercise programme for BS patients, and 2) as an example of the application of the CERT criteria.Trial registrationThe trial was prospectively registered at Clinicaltrials.gov NCT03497546 on April 13, 2018.
| S-EPMC6729089 | biostudies-literature
Project description:BackgroundBariatric surgery is an effective approach to weight loss and long-term comorbidity resolution. Although recommended in several guidelines, supervised exercise has not been systematically prescribed after bariatric surgery. The aim of this study is to determine the effects of two types of exercise, moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT), on body composition, cardiopulmonary function, and perceived quality of life in bariatric surgery patients.MethodsThis randomized controlled exploratory pilot trial will include 75 adults of both sexes scheduled for bariatric surgery. They will be randomly assigned to one of three groups: (1) MICT, (2) HIIT, or (3) a control group. The intervention will occur 2?days a week for 4?months. Outcomes will be assessed at four points: (1) 1 week before surgery, (2) 21?days after surgery (baseline before the exercise program), (3) 8?weeks after beginning the exercise program, and (4) 1 week after the end of intervention. Primary outcomes will include body composition, heart rate variability, and 6-min walk test and quality of life scores. Secondary outcomes will be maximal respiratory pressure, flowmeter, hand dynamometry, and 30-s sit-to-stand test results.DiscussionBoth exercise protocols in this study were developed according to evidence-based practice. It is expected that, after 16?weeks of intervention, body composition (measured by electrical bioimpedance), cardiopulmonary function (measured by heart rate variability, maximal inspiratory pressure, maximal expiratory pressure, peak expiratory flow, handgrip strength, and the 6-min walk test), and perceived quality of life (measured by the Moorehead-Ardelt quality of life questionnaire II and bariatric analysis and reporting outcome system scores) will improve, especially in the HIIT group.Trial registrationClinicalTrials.gov NCT04235842 . Registered on 22 January 2020.
| S-EPMC7849097 | biostudies-literature
Project description:Bariatric surgery is the most efficacious treatment for obesity, though it is not free from complications. Preoperative conditioning has proved beneficial in various clinical contexts, but the evidence is scarce on the role of prehabilitation in bariatric surgery. We describe the protocol and pilot study of a randomized (ratio 1:1), parallel, controlled trial assessing the effect of a physical conditioning and respiratory muscle training programme, added to a standard 8-week group intervention based on therapeutical education and cognitive-behavioural therapy, in patients awaiting bariatric surgery. The primary outcome is preoperative weight-loss. Secondary outcomes include associated comorbidity, eating behaviour, physical activity, quality of life, and short-term postoperative complications. A pilot sample of 15 participants has been randomized to the intervention or control groups and their baseline features and results are described. Only 5 patients completed the group programme and returned for assessment. Measures to improve adherence will be implemented and once the COVID-19 pandemic allows, the clinical trial will start. This is the first randomized, clinical trial assessing the effect of physical and respiratory prehabilitation, added to standard group education and cognitive-behavioural intervention in obese patients on the waiting list for bariatric surgery. Clinical Trial Registration: NCT0404636.
| S-EPMC8465022 | biostudies-literature
Project description:IntroductionBariatric surgery is one of the treatments for severe obesity, with proven efficacy in reducing weight and diseases associated with obesity. Weight loss associated with bariatric surgery is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, which leads us to induce that after bariatric surgery, patients incur an increased risk of sarcopenia. The need for prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the long-term surgical success of bariatric and metabolic surgery. The aim of this randomized clinical trial will be to study the effects of a 16-week supervised exercise intervention program on the prevention of sarcopenia, in patients undergoing bariatric surgery. As a secondary purpose, it is also intended to characterize metabolic risk factors, physical fitness, and quality of life in post-bariatric surgery patients.MethodA total of 45 patients on the waiting list for bariatric surgery and who have subsequently perfurgery, will be include on EXPOBAR (EXercise POst BARiatric) and randomized into 2 groups, experimental and control. The intervention starts one month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity, physical fitness, and sedentary behavior will be determined. For each participant, outcomes are measured at five different time points: before the surgery, before the exercise program, after the exercise program, six and twelve months after de exercise program.ResultsThis study will provide the effects of a physical exercise on sarcopenia, in patients after bariatric surgery.Trial registrationThe trial was registered at Clinicaltrials.gov NCT03497546.
| S-EPMC9768230 | biostudies-literature
Project description:BackgroundThe expansion of digital devices and widespread access to the Internet has opened up opportunities to provide patients with more personal information. It can be hypothesized that eHealth in addition to standard care could enhance clinical outcomes such as increased weight loss, co-morbidity reduction, and commitment to the program. The beneficial value of incorporating eHealth applications as standard postoperative care is yet to be established. In this trial, the value of different levels of eHealth are assessed.Methods/designTwo hundred adult patients with a body mass index (BMI) ≥ 40 kg/m2, or ≥ 35 kg/m2 with obesity-related co-morbidity, undergoing sleeve gastrectomy or gastric bypass will be enrolled in this randomized controlled trial. Patients will be randomly assigned to one of the groups: receiving standard care (control group, n = 100); have access to an online eHealth platform in addition to the previous group (online group, n = 50); or receive wireless monitoring devices in addition to previous groups (device group, n = 50). The total follow-up period is two years postoperatively. Primary outcome is weight loss in terms of BMI. Secondary outcomes include: quality of life; return-to-work time; co-morbidity reduction; additional contacts; and ease of use of devices.DiscussionIn this trial, the value of different levels of eHealth will be assessed. This addresses an important aspect of a changing healthcare environment.Trial registrationTrialregister.nl, NTR6827. Retrospectively registered on 19 November 2017. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6827 .
| S-EPMC6237032 | biostudies-literature
Project description:Background and objectivesWe previously showed in a 6-month randomized controlled trial that resistance training and protein supplementation after bariatric surgery (Roux-en-Y gastric bypass, RYGB) improved muscle strength without significant effect on weight loss and body composition changes. We performed a 5-year follow-up study in these subjects with the aim 1) to assess the long-term effect of this exercise training intervention and 2) to analyze associations between habitual physical activity (PA) and weight regain at 5 years.MethodsFifty-four out of 76 initial participants (follow-up rate of 71%) completed the 5-year follow-up examination (controls, n = 17; protein supplementation, n = 22; protein supplementation and resistance training, n = 15). We measured body weight and composition (DXA), lower-limb strength (leg-press one-repetition maximum) and habitual PA (Actigraph accelerometers and self-report). Weight regain at 5 years was considered low when <10% of 12-month weight loss.ResultsMean (SD) time elapse since RYGB was 5.7 (0.9) y. At 5 years, weight loss was 32.8 (10.1) kg, with a mean weight regain of 5.4 (SD 5.9) kg compared with the 12-month assessment. Moderate-to-vigorous PA (MVPA) assessed by accelerometry did not change significantly compared with pre-surgery values (+5.2 [SD 21.7] min/d, P = 0.059), and only 4 (8.2%) patients reported participation in resistance training. Muscle strength decreased over time (overall mean [SD]: -49.9 [53.5] kg, respectively, P<0.001), with no statistically significant difference between exercise training intervention groups. An interquartile increase in MVPA levels was positively associated with lower weight regain (OR [95% CI]: 3.27 [1.41;9.86]).ConclusionsEarly postoperative participation in a resistance training protocol after bariatric surgery was not associated with improved muscle strength after 5 years of follow-up; however, increasing physical activity of at least moderate intensity may promote weight maintenance after surgery. PA may therefore play an important role in the long-term management of patients with obesity after undergoing bariatric procedure.
| S-EPMC9286216 | biostudies-literature
Project description:BackgroundObesity represents a major public health problem and is the fifth leading risk factor for mortality. Morbid obesity is associated with chronic systemic inflammation which increases the risk of comorbidities. Bariatric surgery (BS) is considered an effective intervention for obese patients. However, BS is associated with dietary restriction, potentially limiting physical activity. Whole-body neuromuscular electrical stimulation (WBS) could represent an innovative option for the rehabilitation of BS patients, especially during the early postoperative phase when other conventional techniques are contraindicated. WBS is a safe and effective tool to combat sarcopenia and metabolic risk as well as increasing muscle mass, producing greater glucose uptake, and reducing the proinflammatory state. Therefore, the objective of this study is to evaluate the effects of WBS on body composition, functional capacity, muscle strength and endurance, insulin resistance, and pro- and anti-inflammatory circulating markers in obese patients undergoing BS.Methods/designThe present study is a randomized, double-blind, placebo-controlled, parallel groups clinical trial approved by the Ethics Committee of our Institution. Thirty-six volunteers (body mass index (BMI)?>?35 kg/m2) between 18 and 45 years of age will be randomized to the WBS group (WBSG) or control (Sham) group (ShamG) after being submitted to BS. Preoperative assessments will include maximal and submaximal exercise testing, body composition, blood inflammatory markers, and quadriceps strength and endurance. The second day after discharge, body composition will be evaluated and a 6-min walk test (6MWT) will be performed. The WBS or Sham protocol will consist of 30 daily sessions for 6 consecutive weeks. Afterwards, the same assessments that were performed in the preoperative period will be repeated.DiscussionConsidering the important role of WBS in skeletal muscle conditioning and its value as an aid in exercise performance, the proposed study will investigate this technique as a tool to promote early rehabilitation in these patients, and as a strategy to enhance exercise capacity, weight loss, and peripheral muscle strength with positive systemic effects. The present study is still ongoing, and data will be published after its conclusion.Trial registrationREBEC, RBR-99qw5h . Registered on 20 February 2015.
| S-EPMC6211515 | biostudies-literature
Project description:Severe obesity is a chronic disease and bariatric surgery is the treatment with more proven efficacy in reducing weight. After surgery, the weight loss is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, with an increased risk of sarcopenia for these patients. Prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the long-term surgical success of bariatric and metabolic surgery. This article aims to describe a protocol using supervised exercise applied after bariatric surgery on skeletal muscle mass index, body composition and strength to determinate sarcopenia in bariatric patients. A RCT will be conducted with 46 patients. Baseline measures will be compared with measures after de exercise program, in five different chronologic times. Participants will be randomly allocated to: 1) combined exercise group or 2) control group. The intervention will be 16 weeks for a combined exercise, started 1 month after surgery. The present study is expected to generate significant information about the role of exercise in patients undergoing bariatric surgery.
| S-EPMC9926297 | biostudies-literature
Project description:We reported that skeletal muscle insulin sensitivity was restored to a lean phenotype with exercise training in patients undergoing RYGB surgery. For that, the goals of this study is to identify changes in the skeletal muscle transcriptome profiling (RNA-seq) that could explain the insulin sensitivity improvement of RYGB + exercise training group.
2020-05-19 | GSE137631 | GEO
Project description:BackgroundSupervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.MethodsThis multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions.DiscussionThe SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH.Trial registrationISRCTN no. 10608766, prospectively registered on 18th March 2019.
| S-EPMC7236437 | biostudies-literature