Physical Exercise in Postoperative Bariatric Surgery Patients

April 12, 2024 updated by: Antonio Roberto Zamunér, Universidad Católica del Maule

Effects of Physical Exercise in Postoperative Bariatric Surgery Patients

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Three groups will be studied:

  1. Control group (CG)
  2. Group of moderate intensity continuous aerobic exercise (GMICT)
  3. High intensity interval aerobic exercise group (GHIIT)

The CG will follow the usual protocol adopted by the hospital San Juan de Dios, Curicó, Chile. The protocol consists in delivering information about relevance of engage in regular physical exercise practice according to the World Health Organization (150 minutes of activity per week moderate physical or at least 75 minutes of intense physical activity), but do not include the patients in a supervised physical exercise program.

The GMICT will undergo a physical exercise program in which the aerobic component will be a moderate-intensity continuous exercise training (60% of the heart rate reserve).

The GHIIT will undergo the same exercise program of the GMICT, but the aerobic component will be a high-intensity interval exercise training (10 sets of 1 min at 90% of heart rate reserve, with 1 min of rest between sets).

All groups will receive a nutritional diet plan prescribed by a specialist bariatric nutritionist blinded to the participants group assignment.

At the end of the study, the CG will be invited to enjoy the exercise program showing to be more effective.

Outcomes will be assessed at four time points: 1) one week before surgery; 2) 21 days after surgery (baseline before start exercise program); 3) 8 weeks after the beginning of the exercise program; and 4) one week after the end of intervention.

Main outcomes are: 1) body composition; 2) heart rate variability; 3) six-minute walk test and 4) quality of life. Secondary outcomes will be: 1) maximal respiratory pressures; 2) flowmeter; 3) dynamometry of upper limb; and 4) squat test in 30 seconds.

All procedures will be performed in the Hospital of Curicó, Chile, at the Department of Physical Medicine and Rehabilitation Service.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Antonio R Zamuner, PhD
  • Phone Number: +56987447384
  • Email: azamuner@ucm.cl

Study Locations

  • Chile
    • Maule
      • Curicó, Maule, Chile
        • Hospital San Juan de Dios de Curicó

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group (CG)
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.
Experimental: Moderate-intensity continuous exercise training group (GMICT)
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
Moderate-intensity continuous exercise training performed at cycle ergometer.
Experimental: High-intensity interval training exercise group (GHIIT)
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.
High-intensity interval training performed at cycle ergometer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat (%)
Time Frame: 16 weeks
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)
Time Frame: 16 weeks
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)
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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)
Time Frame: 16 weeks
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)
Time Frame: 16 weeks
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)
Time Frame: 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal inspiratory and expiratory pressures (cmH2O)
Time Frame: 16 weeks
To determine the effects of HIIT and MCIT on the maximal inspiratory and expiratory pressures.
16 weeks
Flowmeter (L/min)
Time Frame: 16 weeks
To determine the effects of HIIT and MCIT on the peak expiratory flow.
16 weeks
Hand grip strength test (Kg)
Time Frame: 16 weeks
To determine the effects of HIIT and MCIT on the maximum prehensile force will be measured.
16 weeks
30-sec chair stand test (count)
Time Frame: 16 weeks
To determine the effects of HIIT and MCIT on cardiopulmonary function the number of squats in 30 seconds will be counted.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica del Maule

Investigators

  • Study Director: Antonio R Zamunér, PhD, Universidad Católica del Maule

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 284/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In order to protect the privacy, data will be stored and coded. At the end of the study, data may be available upon a reasonable request and ensuring the participants' data confidentiality will be preserved.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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