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, randomized controlled clinical trial with two parallel groups: an intervention group and a control group. A total of 87 adults aged 18 to 60 years who have undergone sleeve gastrectomy or Roux-en-Y gastric bypass and have a medical indication for metabolic rehabilitation will be recruited.
The intervention group will participate in a structured, semi-supervised concurrent exercise program for 5 weeks, consisting of two in-person sessions per week (10 sessions in total), whereas the control group will continue receiving usual kinesiology care and standard clinical management according to the institutional rehabilitation protocol at Clínica BUPA Santiago. All participants will be assessed at two time points: baseline, during the fourth postoperative week, and at week 7.
The primary outcome will be the change in rectus femoris muscle quality assessed by ultrasound (echo intensity). Secondary outcomes will include body composition (bioelectrical impedance analysis), functional response (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 assessed as the percentage of attendance at supervised exercise sessions, and its association with the magnitude of changes in study outcomes will be explored.
The findings are expected to provide clinically relevant evidence regarding the effectiveness of exercise during the early postoperative period and to contribute to the optimization of metabolic rehabilitation strategies following bariatric surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-60 years.
Participants eligible for the institutional PAD (Pago Asociado a Diagnóstico) bariatric surgery program with medical indication for metabolic rehabilitation.
Undergoing sleeve gastrectomy or Roux-en-Y gastric bypass at Clínica BUPA Santiago.
Medical indication for metabolic rehabilitation.
Disqualifiers
Type 1 diabetes mellitus or type 2 diabetes mellitus with severe complications (including stage G4-G5 nephropathy, severe autonomic neuropathy, or high risk of exercise-related hypoglycemia).
Severe musculoskeletal disorders limiting participation in the exercise program.
Acute cardiovascular event within the previous 3 months or medical contraindication to supervised exercise.
Severe cardiorespiratory disease or 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.
Usual Metabolic Rehabilitation Program
BehavioralUsual institutional metabolic rehabilitation program at Clínica BUPA Santiago based on the FITT principle (Frequency, Intensity, Time, and Type of exercise). The program includes supervised continuous aerobic exercise, targeted muscle strengthening, and stretching delivered twice weekly for 5 weeks according to the institutional clinical protocol.
Treatment groups
87 Participants
are divided into 2 treatment groupsGroup A: Concurrent Physical Exercise ProgramExperimental treatment 1 intervention
Group B: Usual Metabolic Rehabilitation ProgramActive comparator 1 intervention
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
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Universidad Autónoma de Chile
Lead sponsor
Clinica Bupa Santiago
Collaborator
Source ClinicalTrials.gov