Concurrent Exercise Effects in Post-Bariatric Patients

NCT07423780 | Recruiting

• 1 other identifier: CEC CBS /3-2025
• Study Type: interventional
• Target: 84
• 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, 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.

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

Intervention group undergoing a concurrent exercise program (aerobic and resistance training) during the postoperative period after bariatric surgery. Participants enter the study at postoperative week 4 and complete a baseline assessment before starting the program. The intervention lasts 5 weeks and includes 10 supervised in-person sessions (2 per week, approximately 60 minutes each) and one recommended weekly home-based session guided by a prescribed exercise plan. After completing the program, a 1-week period without supervised sessions is observed, and the post-intervention assessment is conducted at week 7 from baseline.

Behavioral: Concurrent Exercise Program

Usual Care

NO INTERVENTION

Control group that continues with usual clinical care as indicated by the healthcare team, without participating in a structured physical exercise program during the study period. Participants are assessed at the same time points as the intervention group (baseline and at 7 weeks).

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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, M. K., Ardelt-Gattinger, E., Lechner, H., & Oria, H. E. (2003). La validación del Cuestionario de Calidad de Vida Moorehead-Ardelt II. Cirugía de Obesidad, 13(5), 684-692. https://doi.org/10.1381/096089203322509237

  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-Ramírez, J., Troncoso-Ortiz, E. J., Pino, J., Olivares, M., Escaffi, M. J., Riffo, A., Podestá D, I., Vásquez M, M., & González-Rojas, L. (2019). Recomendaciones de actividad física y ejercicio en el paciente adulto sometido a cirugía bariátrica. Ejercicio y actividad física en adultos sometidos a cirugía bariátrica. Documento de consenso]. Revista médica de Chile, 147(11), 1468-1486. https://doi.org/10.4067/S0034-98872019001101468

  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

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: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking is used. This is an open-label, non-randomized study with two groups (intervention and control), in which both participants and study staff are aware of group allocation. Outcome assessments are performed without blinding.
• 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, non-randomized controlled study with two parallel groups (intervention and control). Participants will enter the study at postoperative week 4 and will be assessed at two time points: baseline and 7 weeks after baseline (following 5 weeks of intervention and 1 week of rest). The intervention group will complete a 5-week concurrent exercise program (aerobic and resistance training), consisting of two supervised in-person sessions per week (10 sessions total) and one recommended home-based session per week. The control group will continue with usual care without participating in a structured exercise program during the study period. Changes in outcomes will be analyzed both within and between groups. Additionally, adherence to the exercise program (attendance to supervised sessions) will be evaluated in the intervention group, and its association with the magnitude of changes in outcomes will be explored under a dose-response framewor

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: May 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)