Concurrent Exercise Effects in Post-Bariatric Patients
Recruiting · NCT07423780 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Clínica BUPA, Santiago - Santiago, Santiago Metropolitan, Chile