Supervised exercise after bariatric surgery to protect muscle and bone
CLINICAL TRIAL ON THE EFFECT OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY)
This program tests whether supervised exercise after gastric bypass or sleeve surgery helps preserve muscle mass and bone density in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospitales Universitarios Virgen del Rocío Academic / other |
| Locations | 2 sites (Seville, Sevilla and 1 other locations) |
| Trial ID | NCT07324447 on ClinicalTrials.gov |
What this trial studies
Adults listed for bariatric surgery at Hospital Universitario Virgen del Rocío will follow either a supervised postoperative physical exercise program or usual care without a structured exercise program. Investigators will measure muscle mass and bone mineral density by densitometry and evaluate muscle function with handgrip testing. Secondary measures include body composition, maximal fat oxidation, resolution of type 2 diabetes and hypertension, and quality of life. Assessments occur over the postoperative follow-up period to compare outcomes between groups.
Who should consider this trial
Good fit: Adults (≥18) scheduled for gastric bypass or sleeve at Hospital Universitario Virgen del Rocío who are medically cleared for exercise and can travel within 60 km or 45 minutes to Pablo de Olavide University.
Not a fit: Patients with conditions affecting bone health, those heavier than 150 kg, on dialysis, cancer survivors, or living beyond the distance limit may be excluded or unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the supervised exercise program could reduce postoperative losses of muscle and bone, improve physical function, and enhance metabolic and quality-of-life outcomes.
How similar studies have performed: Prior studies often show supervised exercise preserves muscle mass and improves fitness after bariatric surgery, but evidence that it prevents bone mineral density loss is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA Patients who are on the waiting list for bariatric surgery (gastric bypass or sleeve) at the Hospital Universitario Virgen del Rocío in Seville, in addition to: * Be 18 years of age or older. * Suitable for physical exercise. * Signature of informed consent. EXCLUSION CRITERIA. * Body weight greater than 150kg. * Distance from the place of residence to the Pablo de Olavide University in Seville greater than 60 km or 45 minutes by car. * Having any of the following conditions: lipedema, cancer survivors, metabolic bone diseases, consumption of medication or presence of pathology that affects bone health. * Patients undergoing dialysis.
Where this trial is running
Seville, Sevilla and 1 other locations
- Hospital virgen del rocio — Seville, Sevilla, Spain (Recruiting)
- Universidad Pablo de Olavide — Seville, Sevilla, Spain (Recruiting)
Study contacts
- Study coordinator: Isaias Alarcon, MD PhD
- Email: isaiasalarcon@gmail.com
- Phone: +34646357875
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.