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Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study.

ABSTRACT: 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.

SUBMITTER: Garcia-Delgado Y

PROVIDER: S-EPMC8465022 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study.

García-Delgado Yaiza Y López-Madrazo-Hernández María José MJ Alvarado-Martel Dácil D Miranda-Calderín Guillermo G Ugarte-Lopetegui Arantza A González-Medina Raúl Alberto RA Hernández-Lázaro Alba A Zamora Garlene G Pérez-Martín Nuria N Sánchez-Hernández Rosa María RM Ibarra-González Adriana A Bengoa-Dolón Mónica M Mendoza-Vega Carmen Teresa CT Appelvik-González Svein Mikael SM Caballero-Díaz Yurena Y Hernández-Hernández Juan Ramón JR Wägner Ana María AM

Nutrients 20210824 9

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 b ...[more]

PMID: 34578781

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Project description:BackgroundPhysical activity levels after bariatric surgery are usually low, despite the significant protective health benefits of physical activity in this population. Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative associations with physical activity that prevent sustained engagement.ObjectiveThe Gaining Optimism After weight Loss Surgery (GOALS) pilot randomized controlled trial is aimed at testing a novel intervention to increase physical activity after bariatric surgery, which incorporates positive psychological skill-building with motivational interviewing and goal-setting.MethodsThe GOALS trial is a 2-arm, 24-week pilot randomized controlled trial that aims to enroll 58 adults who report less than 200 minutes per week of moderate to vigorous physical activity and a desire to become more active 6-12 months after bariatric surgery. GOALS is testing the feasibility, acceptability, and preliminary efficacy of a positive psychology-motivational interviewing telephone intervention targeting to increase physical activity and associated positive affect. Intervention components include positive psychology, goal-setting, self-monitoring via provided Fitbits, and motivational interviewing to overcome barriers and increase motivation. The intervention is compared to a physical activity education control that includes mailings with psychoeducation around physical activity and provision of a Fitbit. The primary outcomes of the pilot trial are feasibility and acceptability, measured as session completion rates and participant ratings of ease and helpfulness of each session. The main secondary outcome is change in accelerometer-measured moderate to vigorous physical activity post intervention and at 24-week follow-up. Additional outcomes include changes in attitudes related to physical activity, psychological well-being, and physical health measures.ResultsThis multiphase project was funded in 2020 and institutional review board approval was obtained for the proposed trial in 2021. Recruitment for the randomized controlled trial began in July 2022. Upon completion of the pilot trial, we will examine the feasibility, acceptability, and preliminary efficacy of the intervention.ConclusionsAlthough bariatric surgery is the most effective treatment available for severe obesity, weight regain occurs, often in the context of low psychological well-being. Many individuals would benefit from learning strategies to increase positive psychological well-being after bariatric surgery, which could help them maintain lifestyle changes. Positive psychology is a novel approach to improve adherence by increasing positive associations with health behaviors including physical activity. The GOALS pilot trial will determine whether this type of intervention is feasible and acceptable to this population and will provide a foundation for a future full-scale randomized controlled efficacy trial.Trial registrationClinicalTrials.gov NCT04868032; https://clinicaltrials.gov/ct2/show/NCT04868032.International registered report identifier (irrid)PRR1-10.2196/39856.

Project description:BackgroundDegenerative lumbar spinal stenosis is a prevalent condition in adults over the age of 65 and often leads to deconditioning. Although the benefits of surgery outweigh those of conservative approaches, physical rehabilitation may be used to improve function and to minimize the risk of persistent dysfunction. This study protocol was designed to establish the feasibility of a full-scale randomized controlled trial and to assess the efficacy of an active preoperative intervention program on the improvement of clinical parameters and functional physical capacity in patients undergoing surgery for lumbar spinal stenosis.Methods/designForty patients will be recruited and randomly allocated to one of the 2 treatment arms: 6 weeks supervised preoperative rehabilitation program (experimental group) or hospital standard preoperative management (control group). The intervention group will be trained three times per week, with each session aiming to improve strength, muscular endurance, spinal stabilization and cardiovascular fitness. Intensity and complexity of exercises will be gradually increased throughout the sessions, depending on each participant's individual progress. Primary outcomes are level of low back disability and level of pain. Secondary outcomes include the use of pain medication, quality of life, patient's global impression of change, lumbar extensor muscles endurance, maximum voluntary contraction of lumbar flexor and extensor muscles, maximum voluntary contraction of knee extensors, active lumbar ranges of motion, walking abilities, and cardiovascular capacity. Both the primary and secondary outcomes will be measured at baseline, at the end of the training program (6 weeks after baseline evaluation for control participants), and at 6 weeks, 3 and 6 months postoperatively.DiscussionThis study will inform the design of a future large-scale trial. Improvements of physical performances before undergoing lumbar surgery may limit functional limitations occurring after a surgical intervention. Results of this study will provide opportunity to efficiently improve spinal care and advance our knowledge of favorable preoperative strategies to optimize postoperative recovery.Trial registrationUS National Institutes of Health Clinical Trials registry NCT02258672 , 10 February 2014.

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.

Dataset Information

Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study.

Publications

Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study.

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