This study will examine within-subject (pre-post) changes in muscle quality, body composition, and functional response following a concurrent exercise program (aerobic + resistance training) in individuals after bariatric surgery. This is a single-center, prospective, longitudinal, quasi-experimental study with a one-group pre-post design. Men and women aged 18 to 60 years who have undergone sleeve gastrectomy or gastric bypass at BUPA Clinic Santiago, are PAD voucher beneficiaries, and have a medical indication for metabolic rehabilitation will be included. Participants will enter the study from postoperative week 4, when the baseline assessment will be performed and the program will begin. The intervention will consist of a 5-week supervised program delivered as two in-person sessions per week (10 sessions in total), each lasting approximately 60 minutes; additionally, participants will be prescribed one autonomous home-based session per week guided by an exercise plan provided by the responsible professional (as a complementary recommendation, not systematically recorded for adherence calculation). After the program, a 1-week period without supervised sessions will be observed, and the final assessment will be performed during the following week. Therefore, outcomes will be measured at two time points: baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest). Adherence will be assessed exclusively as the attendance rate to the 10 supervised in-clinic sessions during the 5-week intervention period, calculated as: adherence (%) = (attended supervised sessions / 10) × 100; for descriptive purposes, adherence will be categorized as high (≥80%), moderate (60-79%), or low (\<60%). Exploratory analyses will examine the association between adherence (%) and the magnitude of pre-post changes in primary outcomes using multivariable linear regression models, adjusting for weight change during the intervention period (Δweight = post-intervention weight - baseline weight). Muscle quality will be assessed using musculoskeletal ultrasound of the rectus femoris (Philips Lumify) with ImageJ image analysis, including thickness measures and parameters related to fat infiltration/echo intensity and area according to a standardized protocol. Body composition will be assessed by bioelectrical impedance analysis (InBody S10). Functional response will be measured using the One-minute Sit-to-Stand Test (1min-STST), with vital signs and perceived exertion (modified Borg scale) recorded as appropriate. Quality of life will be assessed as a secondary outcome using the Moorehead-Ardelt II questionnaire. The expected results will provide clinically relevant evidence on within-subject changes and on the association between adherence to a concurrent exercise program and muscle-related outcomes, supporting optimization of postoperative metabolic rehabilitation after bariatric surgery.
Bariatric surgery is an effective treatment for severe obesity; however, the rapid postoperative weight loss period is frequently accompanied by unfavorable changes in body composition, including reductions in lean mass and muscle performance, which may compromise functional capacity during recovery. Therapeutic exercise is commonly recommended as part of metabolic rehabilitation; nevertheless, evidence regarding short, structured programs initiated early after surgery-and particularly regarding changes in muscle quality-remains limited. This study will evaluate within-subject changes in muscle quality, body composition, and functional response following a concurrent exercise program in adults after bariatric surgery. Additionally, the association between exercise adherence and the magnitude of change in primary outcomes will be explored using multivariable analytical models. This is a single-center, prospective, longitudinal, quasi-experimental study with a one-group pre-post design. Participants will be recruited from BUPA Clinic Santiago and will include men and women aged 18 to 60 years who underwent sleeve gastrectomy or Roux-en-Y gastric bypass, are PAD voucher beneficiaries, and have a medical indication for metabolic rehabilitation. After eligibility screening and informed consent, participants will enter the protocol at postoperative week 4, when baseline assessments will be performed; the intervention will begin immediately after baseline testing. The intervention consists of a 5-week concurrent exercise program combining aerobic and resistance training, delivered as two supervised in-person sessions per week (10 sessions total), approximately 60 minutes each, plus one autonomous home-based session per week guided by a written exercise plan provided by the responsible professional. Training progression will be individualized according to participant tolerance and safety parameters. Aerobic intensity will be monitored using the Borg Rating of Perceived Exertion scale, progressing from moderate levels at the beginning of the program to higher perceived exertion toward the final week. Resistance training loads will be prescribed using relative intensity based on one-repetition maximum (1RM) estimation and progressed weekly, focusing on major muscle groups and emphasizing controlled technique. Vital signs may be monitored as clinically appropriate before and after sessions and/or functional testing. The home-based session will be considered a complementary recommendation and will not be systematically recorded for adherence calculation. After completion of the 5-week intervention, participants will undergo a 1-week post-program period without supervised sessions (rest week). Post-intervention assessments will then be performed during the following week. Therefore, outcomes will be measured at two time points: baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest). Muscle quality will be assessed by musculoskeletal ultrasound of the rectus femoris using Philips Lumify, and images will be analyzed with ImageJ following a standardized approach to quantify parameters such as muscle thickness and metrics related to fat infiltration/echo intensity and cross-sectional area, according to the protocol used. Body composition will be evaluated using bioelectrical impedance analysis (InBody S10). Functional response will be measured using the One-minute Sit-to-Stand Test (1min-STST), recording repetitions and perceived exertion using the modified Borg scale; additional functional measures may include handgrip strength depending on the final protocol specification. Quality of life will be assessed as a secondary outcome using the Moorehead-Ardelt II questionnaire. Adherence will be assessed exclusively as attendance to the 10 supervised in-person sessions during the 5-week intervention period, calculated as: adherence (%) = (attended supervised sessions / 10) × 100. For descriptive purposes, adherence will be categorized as high (≥80%), moderate (60-79%), or low (\<60%). Statistical analyses will be conducted using SPSS. Data distribution will be assessed (e.g., Shapiro-Wilk), and within-subject pre-post changes will be analyzed using paired parametric or nonparametric tests as appropriate (paired t-test or Wilcoxon signed-rank test), with effect sizes estimated to support clinical interpretation. To explore associations, correlation analyses (Pearson or Spearman) will be used, and multivariable linear regression models will be constructed to examine the association between exercise adherence (continuous variable) and changes in primary outcomes; complementary analyses using adherence categories (high, moderate, low) will also be performed. Because bariatric surgery produces expected weight loss during the intervention period and this may influence outcomes independently of exercise, weight change will be included as a covariate in regression models, defined as Δweight (kg) = post-intervention weight - baseline weight, where negative values indicate weight loss. The results are expected to provide clinically relevant evidence on within-subject changes and on the association between adherence to an early concurrent exercise program and muscle-related outcomes (muscle quality), body composition, and functional recovery after bariatric surgery, contributing to optimization of postoperative metabolic rehabilitation strategies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
A 5-week concurrent exercise program combining aerobic and resistance training. Participants complete two supervised in-person sessions per week (10 total), approximately 60 minutes each, plus one autonomous home-based session per week guided by a prescribed exercise plan. Training is progressed weekly in intensity and volume according to individual tolerance and safety parameters. Aerobic intensity is monitored using the Borg Rating of Perceived Exertion scale, and resistance training load is progressed using relative intensity based on estimated 1RM. The program is delivered in the postoperative period after bariatric surgery, starting at postoperative week 4. After completion of the 5-week program, participants observe a 1-week period without supervised sessions, and post-intervention assessments are performed during the following week; therefore, outcomes are measured at baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest). Adherence
Clínica BUPA, Santiago
Santiago, Santiago Metropolitan, Chile
RECRUITINGChange 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).
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).
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).
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).
Adherence to the exercise program (supervised in-clinic sessions)
Attendance rate to supervised in-clinic sessions at Clínica BUPA during the intervention. Adherence will be calculated as: adherence (%) = (number of attended sessions / 10) × 100. For descriptive purposes, adherence will be categorized as high (8-10 sessions; ≥80%), moderate (6-7 sessions; 60-79%), and low (0-5 sessions; \<60%). Adherence ≥80% will be considered clinically acceptable.
Time frame: During the 5-week intervention period (calculated at the end of the program based on attendance to the 10 supervised sessions).
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).
Change in visceral fat area (cm²)
Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Visceral fat area (cm²) 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).
Change in basal metabolic rate (kcal/day)
Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Basal metabolic rate (kcal/day) 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).
Change in rectus femoris muscle thickness (cm)
ectus femoris muscle thickness (cm) will be assessed by ultrasound under standardized conditions 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).
Change in rectus femoris cross-sectional area (cm²)
Rectus femoris cross-sectional area (cm²) will be assessed by ultrasound under standardized conditions 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).
Change in fat infiltration measured by ultrasound in the rectus femoris (cm)
Fat infiltration will be assessed by ultrasound in the rectus femoris under standardized conditions at baseline and post-intervention. The measurement will be recorded in centimeters (cm), and 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).
Change in quality of life assessed by the Moorehead-Ardelt II questionnaire
Quality of life will be assessed using the Moorehead-Ardelt II questionnaire, a bariatric surgery-specific instrument that evaluates domains including self-esteem, physical well-being, social relationships, work, and sexuality. Total score (and domain scores, if applicable) will be compared before and after the intervention.
Time frame: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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