Physical Exercise in Postoperative Bariatric Surgery Patients

NCT04235842 | Suspended

• 1 other identifier: 284/2019
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effect of two types of exercise training on body composition, cardiopulmonary function and quality of life in people after undergoing bariatric surgery.

Conditions

Physical Exercise; Bariatric Surgery; Morbid Obesity

Outcome Measures

Primary Outcomes (7)

• Body fat (%)

  To determine the effects of HIIT and MCIT on body composition by measuring percent of body fat using a tetrapolar bioelectrical impedance.

  16 weeks

• Muscle mass (Kg)

  To determine the effects of HIIT and MCIT on body composition by measuring muscle mass using a tetrapolar bioelectrical impedance.

  16 weeks

• Bone mass (Kg)

  To determine the effects of HIIT and MCIT on body composition by measuring bone mass using a tetrapolar bioelectrical impedance.

  16 weeks

• Heart rate variability

  To determine the effects of HIIT and MCIT on cardiac autonomic control in supine and orthostatic positions.

  16 weeks

• Six minutes walk test (mts traveled)

  To determine the effects of HIIT and MCIT on functional capacity using the six-minute walk test.

  16 weeks

• Moorehead-Ardelt Quality of Life Questionnaire (MAQ II)

  To determine the effects of HIIT and MCIT on quality of life by the Moorehead-Ardelt Quality of Life Questionnaire. The score of each answer ranges from -0.5 (most unfavorable situation) to +0.5 (most favorable situation). According to the score obtained: -3 to -2.1: "very poor"; -2 to -1.1: "poor"; -1 to 1: "fair"; 1.1 to 2: "good"; and 2.1 to 3: "very good" quality of life.

  16 weeks

• Bariatric Analysis and Reporting Outcomes System (BAROS Score)

  To determine the effects of HIIT and MCIT on quality of life by the Bariatric Analysis and Reporting Outcomes System. Moorehead-Ardelt questionnaire incorporates the percentage of overweight lost or gained after surgery, resolution of comorbidities associated with morbid obesity, need for reoperation and complications. According to the score obtained, it is categorized as: ≤1: "failure"; \> 1 to 3: "fair"; \> 3 to 5: "good"; \> 5 to 7: "very good"; and \> 7 to 9: excellent.

  16 weeks

Secondary Outcomes (4)

• Maximal inspiratory and expiratory pressures (cmH2O)

  16 weeks

• Flowmeter (L/min)

  16 weeks

• Hand grip strength test (Kg)

  16 weeks

• 30-sec chair stand test (count)

  16 weeks

Study Arms (3)

Control Group (CG)

NO INTERVENTION

The CG will receive the standard indications routinely provided by the hospital which consists in information about practice of regular physical activity according to World Health Organization. A leaflet with illustrations and indications will be provided and will be explained by the principal investigator.

Moderate-intensity continuous exercise training group (GMICT)

EXPERIMENTAL

The GMICT will be submitted to a physical exercise program in which the aerobic component will be a moderate-intensity continuous exercise training, performed at 60% of the heart rate reserve, two days a week, for 30 minutes.

Other: Physical Exercise

High-intensity interval training exercise group (GHIIT)

EXPERIMENTAL

The GHIIT will be will be submitted to a physical exercise program in which the aerobic component will be a high-intensity interval exercise training, performed in a protocol consisted of four one-min sprint at 90% of the heart rate reserve, alternated with one-min rest (at week 1) and progressing until reach 10 bouts of one-min sprint alternated with one-min rest.

Other: High-intensity interval training performed at cycle ergometer.

Interventions

Physical Exercise OTHER

Moderate-intensity continuous exercise training performed at cycle ergometer.

Moderate-intensity continuous exercise training group (GMICT)

High-intensity interval training performed at cycle ergometer. OTHER

High-intensity interval training performed at cycle ergometer.

High-intensity interval training exercise group (GHIIT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons between 18 and 65 years old, both sexes, who have undergone bariatric surgery, with medical authorization to perform physical exercise, that the wound healing process operative is in the final phase, which have been administered with subsequent anti thrombus treatment to surgery, who have no plans to change their place of residence within the current year.

You may not qualify if:

• Persons who have had immediate complications after bariatric surgery (dehiscence anastomosis and operative wound dehiscence), presented any comorbidity decompensation after surgery, who are in the process of dialysis or who suffer from neuromotor disease.

Sponsors & Collaborators

• Universidad Católica del Maule: lead

Study Sites (1)

Hospital San Juan de Dios de Curicó

Curicó, Maule Region, Chile

Location

Related Publications (29)

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• Delgado Floody P, Caamano Navarrete F, Ovalle Elgueta H, Concha Diaz M, Jerez Mayorga D, Osorio Poblete A. Efectos de un programa de ejercicio fisico estructurado sobre los niveles de condicion fisica y el estado nutricional de obesos morbidos y obesos con comorbilidades. Nutr Hosp. 2016 Mar 25;33(2):107. doi: 10.20960/nh.107. Spanish.

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• Delgado Floody P, Caamano Navarrete F, Osorio Poblete A, Jerez Mayorga D. Variaciones en el estado nutricional, presion arterial y capacidad cardiorrespiratoria de obesos candidatos a cirugia bariatrica: beneficios del ejercicio fisico con apoyo multidisciplinar. Nutr Hosp. 2016 Feb 16;33(1):16. doi: 10.20960/nh.v33i1.16. Spanish.

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• Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.

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• Guiraud T, Nigam A, Gremeaux V, Meyer P, Juneau M, Bosquet L. High-intensity interval training in cardiac rehabilitation. Sports Med. 2012 Jul 1;42(7):587-605. doi: 10.2165/11631910-000000000-00000.

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• Herring LY, Stevinson C, Carter P, Biddle SJH, Bowrey D, Sutton C, Davies MJ. The effects of supervised exercise training 12-24 months after bariatric surgery on physical function and body composition: a randomised controlled trial. Int J Obes (Lond). 2017 Jun;41(6):909-916. doi: 10.1038/ijo.2017.60. Epub 2017 Mar 6.

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• Herrera-Santelices A, Tabach-Apraiz A, Andaur-Caceres K, Zamuner AR. Effect of physical exercise in bariatric surgery patients: protocol of a randomized controlled clinical trial. Trials. 2021 Feb 1;22(1):107. doi: 10.1186/s13063-021-05056-4.

  PMID: 33522950 DERIVED

Related Links

• Selection of candidates for bariatric surgery
• Epidemiology of obesity in Chile
• Historias de vida: una metodología de investigación cualitativa.
• Recomendaciones de la SECO para la práctica de la cirugía bariátrica y metabólica
• ¿Cómo analizar datos cualitativos?.
• Evaluación mediante score BAROS de los resultados del bypass gástrico en el tratamiento de la obesidad mórbida
• Alteraciones hepáticas en el paciente con obesidad mórbida sometido a cirugía bariátrica
• Tratamiento con cirugía bariátrica en el paciente obeso.
• Encuesta Nacional De Salud 2016-2017, primeros resultados
• Nota Descriptiva Obesidad y Sobrepeso
• Exercise reduces lean mass loss in obese patients undergoing bariatric surgery
• Evaluation of a structured program of physical exercise in morbidly obese patients awaiting bariatric surgery
• Quality of life: A theoretical review
• BODY COMPOSITION ASSESSMENT IN SPORTS MEDICINE. STATEMENT OF SPANISH GROUP OF KINANTHROPOMETRY OF SPANISH FEDERATION OF SPORTS MEDICINE

MeSH Terms

Conditions

Motor Activity; Obesity, Morbid

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Antonio R Zamunér, PhD

  Universidad Católica del Maule

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to the study intervention the participants were submitted.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor - Principal Investigator

Model Details: Randomized clinical trial, single blinded.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 22, 2020
• Study Start: December 2, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)