Concurrent Exercise Effects in Post-Bariatric Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversidad Autónoma de Chile
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Concurrent Exercise Program
BehavioralConcurrent 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Concurrent Physical Exercise ProgramExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in rectus femoris muscle quality (echo intensity; grayscale units 0-255)
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.
Time frame
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).Secondary outcomes
1
Change in percent body fat (%)
Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Percent body fat (%) will be recorded at baseline and post-intervention. Change will be calculated as Δ = post - pre.
Time frame
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).2
Change in fat mass (kg)
Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Fat mass (kg) will be recorded at baseline and post-intervention. Change will be calculated as Δ = post - pre.
Time frame
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).3
Change in skeletal muscle mass (kg)
Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Skeletal muscle mass (kg) will be recorded at baseline and post-intervention. Change will be calculated as Δ = post - pre.
Time frame
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).4
Change in 1-minute Sit-to-Stand performance (1min-STST)
Functional response will be assessed using the One-minute Sit-to-Stand Test (1min-STST). The primary metric is the total number of completed repetitions in 60 seconds performed using a standard chair. Perceived exertion (modified Borg scale) may be recorded as a complementary measure.
Time frame
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Autónoma de Chile
Lead sponsor
Clinica Bupa Santiago
Collaborator
Source ClinicalTrials.gov