RecruitingNot ApplicableNCT07423780

Concurrent Exercise Effects in Post-Bariatric Patients

Effect of a Concurrent Exercise Program on Muscle Quality, Body Composition, Functional Response, and Quality of Life in Individuals Undergoing Bariatric Surgery


Sponsor

Universidad Autónoma de Chile

Enrollment

84 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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.

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Interventions

BEHAVIORALConcurrent Exercise Program

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.


Locations(1)

Clínica BUPA, Santiago

Santiago, Santiago Metropolitan, Chile

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NCT07423780


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