Exercise program to improve weight, strength, and recovery around bariatric surgery
Impact of a Structured Physical Exercise Program on Body Composition in Morbid Obesity: A Randomized Controlled Trial
This program will test whether a structured exercise plan supported by telerehabilitation helps adults with severe obesity who are having bariatric surgery lose more body fat and gain more strength than usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Instituto de Investigacion Sanitaria La Fe Academic / other |
| Locations | 2 sites (Valencia, Valencia and 1 other locations) |
| Trial ID | NCT06934681 on ClinicalTrials.gov |
What this trial studies
This is a randomized clinical trial that will assign 72 adults with severe obesity to either a structured exercise program (with supervised and home-based sessions delivered partly via telerehabilitation) or to usual care including nutritional counseling. The intervention spans the pre- and post-operative periods around bariatric surgery and includes strength and aerobic training components. Primary outcomes include body fat loss and muscle strength, with secondary measures of body composition, functional capacity, quality of life, cardiorespiratory fitness, and selected genetic and metabolic markers. Participants will be evaluated at scheduled in-person visits at the study sites in Valencia and remotely for telerehabilitation sessions.
Who should consider this trial
Good fit: Adults aged 18–65 with BMI ≥40 (or ≥35 with comorbidities) who are scheduled for bariatric surgery and are medically cleared to participate in an exercise program are ideal candidates.
Not a fit: People with uncontrolled cardiovascular disease, uncontrolled diabetes with severe complications, musculoskeletal or systemic conditions that prevent exercise, recent participation in a structured exercise program, or inability to use telerehabilitation may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could help people having bariatric surgery lose more body fat, improve strength and fitness, and recover functional ability more quickly than standard care.
How similar studies have performed: Previous prehabilitation and rehabilitation exercise programs around bariatric surgery have shown improvements in fitness and body composition, but telerehabilitation delivery has been less extensively tested and evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18-65 years * BMI ≥35 with comorbidities, or ≥40, regardless of comorbidity presence Exclusion Criteria: * Participation in a structured physical exercise program within the past 6 months * Presence of musculoskeletal or systemic diseases that prevent participation in a physical exercise program * Uncontrolled hypertension * Uncontrolled diabetes, particularly in the presence of severe complications (neuropathy and/or diabetic foot, proliferative retinopathy) * Uncontrolled or unstable cardiovascular disease (acute myocardial infarction within the past year, angina, heart failure, peripheral artery disease)
Where this trial is running
Valencia, Valencia and 1 other locations
- Facultad de Fisioterapia, universidad de Valencia — Valencia, Valencia, Spain (Active_not_recruiting)
- Hospital La Fe — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Paolo Rossetti, Medicine — IIS La Fe
- Study coordinator: Paolo Rossetti, Medicine
- Email: rossetti_paolo@gva.es
- Phone: +34608109913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.