Concurrent Exercise Effects in Post-Bariatric Patients

NCT07423780 | Recruiting

• 1 other identifier: CEC CBS /4-2026
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Obesity & Overweight; Post-bariatric Surgery

Keywords

Muscle quality; Body composition; Functional capacity; Therapeutic exercise; Quality of life; concurrent exercise; one-minute sit-to-stand; ectus femoris ultrasound; bioelectrical impedance analysis

Outcome Measures

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.

  Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).

Secondary Outcomes (11)

• Change in percent body fat (%)

  Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).

• Change in fat mass (kg)

  Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).

• Change in skeletal muscle mass (kg)

  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)

  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)

  During the 5-week intervention period (calculated at the end of the program based on attendance to the 10 supervised sessions).

Study Arms (2)

Concurrent Physical Exercise Program

EXPERIMENTAL

Participants allocated to the intervention group will complete a structured, semi-supervised concurrent exercise program during the postoperative period following bariatric surgery. Participants will enter the study during postoperative week 4 and undergo a baseline assessment before starting the intervention. The program will last 5 weeks and will include 10 supervised in-person sessions (2 sessions/week, approximately 60 minutes each) and one complementary home-based session per week. After completion of the intervention, participants will remain one week without supervised exercise sessions before the week 7 follow-up assessment.

Behavioral: Concurrent Exercise Program

Usual Metabolic Rehabilitation Program

ACTIVE COMPARATOR

Participants allocated to the control group will receive the usual metabolic rehabilitation program at Clínica BUPA Santiago. The rehabilitation program will follow the FITT principle (Frequency, Intensity, Time, and Type of exercise) and will include two supervised sessions per week for 5 weeks consisting of continuous aerobic exercise, targeted muscle strengthening, and stretching according to the institutional protocol. All participants will undergo baseline and week 7 assessments.

Behavioral: Usual Metabolic Rehabilitation Program

Interventions

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.

Also known as: Concurrent Physical Exercise Program

Concurrent Physical Exercise Program

Usual Metabolic Rehabilitation Program BEHAVIORAL

Usual 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.

Usual Metabolic Rehabilitation Program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Able and willing to provide written informed consent.

You may not qualify if:

• 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.
• Dependence on supplemental oxygen.
• Bariatric surgery complications (e.g., leak, bleeding, stenosis, or intra-abdominal abscess).
• Liver failure, kidney failure, or any other clinical condition compromising safe participation in the exercise program.

Sponsors & Collaborators

• Universidad Autónoma de Chile: lead
• Clinica Bupa Santiago: collaborator

Study Sites (1)

Clínica BUPA, Santiago

Santiago, Santiago Metropolitan, 7820830, Chile

RECRUITING

Related Publications (12)

• Otto-Yanez M, Torres-Castro R, Barros-Poblete M, Barros M, Valencia C, Campos A, Jadue L, Puppo H, Seron P, Vilaro J. One-minute sit-to-stand test: Reference values for the Chilean population. PLoS One. 2025 Jan 29;20(1):e0317594. doi: 10.1371/journal.pone.0317594. eCollection 2025.

  PMID: 39879255 BACKGROUND

• Complicaciones a largo plazo y efectos secundarios de la cirugía bariátrica: una revisión sistemática. Journal of Negative and No Positive Results, 6(6), 582-589. https://doi.org/10.19230/jonnpr.1584

  BACKGROUND

• Moorehead MK, Ardelt-Gattinger E, Lechner H, Oria HE. The validation of the Moorehead-Ardelt Quality of Life Questionnaire II. Obes Surg. 2003 Oct;13(5):684-92. doi: 10.1381/096089203322509237.

  PMID: 14627461 RESULT

• Gonzalez-Molero I, Garcia Arnes JA, Dominguez Lopez M, Gallego JL. [Persistent hypoglycemia in a patient with bariatric surgery]. Med Clin (Barc). 2011 Oct 22;137(11):522-3. doi: 10.1016/j.medcli.2011.01.001. Epub 2011 Mar 10. No abstract available. Spanish.

  PMID: 21396666 RESULT

• National Institute of Diabetes and Digestive and Kidney Diseases. (2020). Efectos secundarios de la cirugía para adelgazar (bariátrica). Recuperado de https://www.niddk.nih.gov/health-information/informacion-de-la-salud/control-de-peso/cirugia-adelgazar-bariatrica/efectos-secundarios

  RESULT

• Muñoz, R., Hernández, J., Palacio, A., Maiz, C., & Pérez, G. (2016). El ejercicio físico disminuye la pérdida de masa magra en pacientes obesos sometidos a cirugía bariátrica. Revista Chilena de Cirugía, 68(6), 303-308. https://doi.org/10.1016/j.rchic.2016.05.007

  RESULT

• Alvero-Cruza, J. R., Correas Gómez, L., Ronconi, M., Fernández Vázquez, R., & Porta i Manzanido, J. (2011). La bioimpedancia eléctrica como método de estimación de la composición corporal, normas prácticas de utilización[Bioelectrical impedance analysis as a method of body composition

  RESULT

• Cancino-Ramirez J, Troncoso-Ortiz EJ, Pino J, Olivares M, Escaffi MJ, Riffo A, Podesta D I, Vasquez M M, Gonzalez-Rojas L. [Exercise and physical activity in adults who underwent bariatric surgery. Consensus document]. Rev Med Chil. 2019 Nov;147(11):1468-1486. doi: 10.4067/S0034-98872019001101468. Spanish.

  PMID: 32186608 RESULT

• McIver CM, Wycherley TP, Clifton PM. MTOR signaling and ubiquitin-proteosome gene expression in the preservation of fat free mass following high protein, calorie restricted weight loss. Nutr Metab (Lond). 2012 Sep 14;9(1):83. doi: 10.1186/1743-7075-9-83.

  PMID: 22974011 RESULT

• Tamboli RA, Hossain HA, Marks PA, Eckhauser AW, Rathmacher JA, Phillips SE, Buchowski MS, Chen KY, Abumrad NN. Body composition and energy metabolism following Roux-en-Y gastric bypass surgery. Obesity (Silver Spring). 2010 Sep;18(9):1718-24. doi: 10.1038/oby.2010.89. Epub 2010 Apr 22.

  PMID: 20414197 RESULT

• Pleticosic-Ramírez Y, Mecías Calvo M, Navarro-Patón R. Efectos de programas de ejercicio físico en la composición corporal, condición física y calidad de vida de personas mayores con sobrepeso u obesidad: Una revisión sistemática effects of physical exercise programs on body composition, physical fitness and quality of life in older people with overweight or obesity: A systematic review.

  RESULT

• Thomas-Lange J. Sobrepeso y obesidad en chile: Consideraciones para su abordaje en un contexto de inequidad social. Rev chil nutr. 2023;50(4):457. doi: 10.4067/s0717-75182023000400457.

  RESULT

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• María José Pabst Pérez, MSc

  Universidad Autónoma de Chile

  PRINCIPAL INVESTIGATOR

• Tomás Vergara Soria, Kinesiólogo

  Clínica BUPA Santiago

  PRINCIPAL INVESTIGATOR

• Sebastian Barrios Valenzuela, Kinesiólogo

  Clínica BUPA Santiago

  STUDY CHAIR

• Luis Astete, MSc

  Universidad Autónoma de Chile

  STUDY CHAIR

• Nicolas Arancibia Ramirez, Kinesiólogo

  Clinica Alemana

  STUDY CHAIR

• Erika Troncoso, MsC

  Clinica las Condes

  STUDY CHAIR

• Rosario Alonso Domínguez, PhD.

  Universidad de Salamanca. España

  STUDY DIRECTOR

• María de la Luz Tocino, PhD.

  University of Salamanca

  STUDY DIRECTOR

• Matias Otto Yañez, PhD.

  Universidad Autónoma de Chile. Chile

  STUDY DIRECTOR

• Paloma Lillo, MsC

  Universidad Silva Henriquez

  STUDY CHAIR

• Carla Martinez Dominguez, Kinesióloga

  Clinica Bupa Santiago

  STUDY CHAIR

• Karen Castañeda Lavin, MsC

  University of Americas

  STUDY CHAIR

Central Study Contacts

María José Pabst Perez, MSc

CONTACT

+56950023025; majose.pabst@gmail.com

Tomás Vergara Soria, Kinesiólogo

CONTACT

+56988289188; tomasvergarasoria21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and treating physical therapists cannot be blinded to group allocation. However, outcome assessors responsible for baseline and post-intervention evaluations will remain blinded to treatment allocation. Assessors will have no access to the randomization sequence, and participants will be instructed not to disclose their assigned intervention during outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Physiotherapist/Doctoral Candidate)

Model Details: This is a single-center, prospective, longitudinal, randomized controlled trial with two parallel groups (intervention and control). Participants will enter the study during the fourth postoperative week and will be assessed at baseline and at week 7. Both groups will receive exercise programs designed according to the FITT principle (Frequency, Intensity, Time, and Type of exercise). The intervention group will complete a structured, semi-supervised concurrent exercise program combining aerobic and resistance training with planned progression of exercise intensity and training volume. The control group will receive the usual institutional metabolic rehabilitation program at Clínica BUPA Santiago, including supervised continuous aerobic exercise, targeted muscle strengthening, and stretching according to the standard clinical protocol.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: February 20, 2026
• Study Start: August 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)