NCT07423780 Concurrent Exercise Effects in Post-Bariatric Patients
| NCT ID | NCT07423780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Autónoma de Chile |
| Condition | Obesity & Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-08-11 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2025-08-11 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the effect of a 5-week concurrent exercise program (aerobic and resistance training) on muscle quality, body composition, functional response, and quality of life in individuals undergoing bariatric surgery. This is a single-center, prospective, longitudinal, non-randomized controlled clinical trial with two groups: intervention and control. A total of 84 adults aged 18 to 60 years who have undergone sleeve gastrectomy or gastric bypass and have a medical indication for metabolic rehabilitation will be recruited. The intervention group will complete a supervised concurrent exercise program for 5 weeks, consisting of two in-person sessions per week (10 sessions in total), while the control group will continue with usual care without participating in a structured exercise program. All participants will be assessed at two time points: baseline (postoperative week 4) and 7 weeks after baseline (after 5 weeks of intervention and 1 week of rest). The primary outcome will be muscle quality of the rectus femoris assessed by ultrasound (echo intensity). Secondary outcomes will include body composition (bioelectrical impedance analysis), functional performance (one-minute sit-to-stand test), and quality of life (Moorehead-Ardelt II questionnaire). Additionally, adherence to the exercise program in the intervention group will be evaluated as the percentage of attendance to supervised sessions, and its association with the magnitude of changes in outcomes will be analyzed under a dose-response framework. The results are expected to provide clinically relevant evidence on the effectiveness of exercise in the early postoperative period and to support the optimization of metabolic rehabilitation strategies after bariatric surgery.
Eligibility Criteria
Inclusion Criteria * Voluntarily agree to participate and sign informed consent. * Men and women aged 18 to 60 years. * Have undergone bariatric surgery (sleeve gastrectomy or gastric bypass) at BUPA Clinic Santiago. * Have a medical indication for metabolic rehabilitation. * May present associated comorbidities such as insulin resistance syndrome, dyslipidemia, arterial hypertension, and/or hypothyroidism. Exclusion Criteria * Diagnosis of type 1 or type 2 diabetes mellitus. * Severe musculoskeletal disorders that impair ambulation or limit participation in the exercise program. * History of a cardiovascular event. * Severe cardiorespiratory diseases that significantly reduce physical capacity or cause dyspnea at rest or with minimal exertion. * Dependence on supplemental oxygen. * Bariatric surgery-related complications, including: * Staple line leak or fistula * Hemorrhage/bleeding * Stenosis or gastric narrowing/stricture * Intra-abdominal abscess * Hypersensitivity (as clinically determined). * Hepatic and/or renal insufficiency.
Contact & Investigator
María José Pabst Pérez, MSc
PRINCIPAL INVESTIGATOR
Universidad Autónoma de Chile
Frequently Asked Questions
Who can join the NCT07423780 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Obesity & Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07423780 currently recruiting?
Yes, NCT07423780 is actively recruiting participants. Contact the research team at majose.pabst@gmail.com for enrollment information.
Where is the NCT07423780 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT07423780 clinical trial?
NCT07423780 is sponsored by Universidad Autónoma de Chile. The principal investigator is María José Pabst Pérez, MSc at Universidad Autónoma de Chile. The trial plans to enroll 84 participants.
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