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Physical Exercise in Postoperative Bariatric Surgery Patients

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ClinicalTrials.gov Identifier: NCT04235842
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Antonio Roberto Zamunér, Universidad Católica del Maule

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.

Condition or disease Intervention/treatment Phase
Physical Exercise Bariatric Surgery Morbid Obesity Other: Physical Exercise Other: High-intensity interval training performed at cycle ergometer. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial, single blinded.
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will be blinded to the study intervention the participants were submitted.
Primary Purpose: Treatment
Official Title: Effects of Physical Exercise in Postoperative Bariatric Surgery Patients
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Heart rate variability [ Time Frame: 16 weeks ]
    To determine the effects of HIIT and MCIT on cardiac autonomic control in supine and orthostatic positions.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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.

  2. Flowmeter (L/min) [ Time Frame: 16 weeks ]
    To determine the effects of HIIT and MCIT on the peak expiratory flow.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235842


Contacts
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Contact: Andrea Herrera, MSc, PT +56950978252 andrea.herrera.s@gmail.com
Contact: Antonio R Zamuner, PhD +56987447384 azamuner@ucm.cl

Locations
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Chile
Hospital San Juan de Dios de Curicó Recruiting
Curicó, Maule, Chile
Contact: Andrea Herrera, MSc, PT    +56950978252    andrea.herrera.s@gmail.com   
Sub-Investigator: Andrea Herrera, MSc, PT         
Sponsors and Collaborators
Universidad Católica del Maule
Investigators
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Study Director: Antonio R Zamunér, PhD Universidad Católica del Maule
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antonio Roberto Zamunér, Adjunct Professor - Principal Investigator, Universidad Católica del Maule
ClinicalTrials.gov Identifier: NCT04235842    
Other Study ID Numbers: 284/2019
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight