Clinical trial

Concurrent Exercise Effects in Post-Bariatric Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT07423780

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Post-bariatric Surgery

Full registry 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.

Treatments and study arms

Concurrent Exercise Program

Behavioral

Concurrent physical exercise program of 5 weeks combining aerobic and resistance training in individuals undergoing bariatric surgery. The program includes two supervised in-person sessions per week (10 sessions total), each lasting approximately 60 minutes, and one recommended weekly home-based session guided by a prescribed exercise plan. Aerobic exercise is performed at moderate to high intensity, monitored using the Borg Rating of Perceived Exertion scale. Resistance training targets major muscle groups and is prescribed based on an estimated one-repetition maximum (1RM), with progression in volume and intensity according to individual tolerance and safety criteria. The program begins at postoperative week 4. After completing the 5-week intervention, participants undergo a 1-week period without supervised sessions before the post-intervention assessment.

Primary outcomes

Change in rectus femoris muscle quality (echo intensity; grayscale units 0-255)Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).

Muscle quality will be assessed by ultrasound as echo intensity (mean grayscale value, 0-255) within a standardized region of interest, analyzed using ImageJ, at baseline and post-intervention. Change will be calculated as Δ = post - pre.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Clínica BUPA, Santiago🇨🇱 Santiago, Santiago Metropolitan, Chile

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Tomás Vergara Soria, KinesiólogoContact

Email · Call +56988289188

Sebastian Barrios, KinesiólogoContact

Email · Call +56984513233

Tomás Vergara Soria, KinesiólogoPrincipal Investigator