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Study protocol
Effect of physical exercise in bariatric surgery patients: protocol of a randomized controlled clinical trial.
Antonio Zamunér
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7480-3047
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Bariatric surgery is an effective approach to weight loss and long-term comorbidity resolution. Although recommended in several guidelines, supervised exercise has not been systematically prescribed after bariatric surgery. The aim of this study is to determine the effects of two types of exercise, moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT), on body composition, cardiopulmonary function and perceived quality of life in bariatric surgery patients.
Methods: This randomized controlled exploratory pilot trial will include 75 adults of both sexes scheduled for bariatric surgery. They will be randomly assigned to one of three groups: 1) MICT, 2) HIIT, or 3) a control group. The intervention will occur 2 days a week for 4 months. Outcomes will be assessed at four points: 1) one week before surgery; 2) 21 days after surgery (baseline before the exercise program); 3) 8 weeks after beginning the exercise program; and 4) one week after the end of intervention. Primary outcomes will include body composition, heart rate variability, and six-minute walk test and quality of life scores. Secondary outcomes will be maximal respiratory pressure, flowmeter, hand dynamometry, and 30-second sit-to-stand test results.
Discussion: Both exercise protocols in this study were developed according to evidence-based practice. It is expected that, after 16 weeks of intervention, body composition (measured by electrical bioimpedance), cardiopulmonary function (measured by heart rate variability, maximal inspiratory pressure, maximal expiratory pressure, peak expiratory flow, handgrip strength, and the six-minute walk test) and perceived quality of life (measured by the Moorehead-Ardelt quality of life questionnaire II and bariatric analysis and reporting outcome system scores) will improve, especially in the HIIT group.
Trial registration: ClinicalTrials.gov, NCT04235842, registered 22 January 2020.
Keywords
Physical Exercise, Bariatric Surgery, Morbid Obesity.
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CURRENT STATUS: Under Review
Version 2
Posted 13 Jan, 2021
No community comments so far
Review #1 received
Received 12 Jan, 2021
Reviewer #3 agreed
On 10 Jan, 2021
Review #3 received
Received 10 Jan, 2021
Reviewer #2 agreed
On 07 Jan, 2021
Review #2 received
Received 07 Jan, 2021
Reviewer #1 agreed
On 06 Jan, 2021
Reviewers invited
Invitations sent on 05 Jan, 2021
Editor assigned
On 29 Dec, 2020
Submission checks complete
On 29 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 29 Nov, 2020
Review #5 received
Received 25 Nov, 2020
Review #1 received
Received 20 Nov, 2020
Review #2 received
Received 19 Nov, 2020
Review #3 received
Received 19 Nov, 2020
Reviewer #5 agreed
On 14 Nov, 2020
Reviewer #4 agreed
On 09 Nov, 2020
Reviewer #3 agreed
On 08 Nov, 2020
Reviewer #2 agreed
On 07 Nov, 2020
Reviewers invited
Invitations sent on 07 Nov, 2020
Reviewer #1 agreed
On 07 Nov, 2020
Editor assigned
On 18 Jul, 2020
Submission checks complete
On 09 Jun, 2020
First submitted
On 27 Apr, 2020
Metrics
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Effect of physical exercise in bariatric surgery patients: protocol of a randomized controlled clinical trial.
Antonio Zamunér
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7480-3047
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 2
Posted 13 Jan, 2021
No community comments so far
Review #1 received
Received 12 Jan, 2021
Reviewer #3 agreed
On 10 Jan, 2021
Review #3 received
Received 10 Jan, 2021
Reviewer #2 agreed
On 07 Jan, 2021
Review #2 received
Received 07 Jan, 2021
Reviewer #1 agreed
On 06 Jan, 2021
Reviewers invited
Invitations sent on 05 Jan, 2021
Editor assigned
On 29 Dec, 2020
Submission checks complete
On 29 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 29 Nov, 2020
Review #5 received
Received 25 Nov, 2020
Review #1 received
Received 20 Nov, 2020
Review #2 received
Received 19 Nov, 2020
Review #3 received
Received 19 Nov, 2020
Reviewer #5 agreed
On 14 Nov, 2020
Reviewer #4 agreed
On 09 Nov, 2020
Reviewer #3 agreed
On 08 Nov, 2020
Reviewer #2 agreed
On 07 Nov, 2020
Reviewers invited
Invitations sent on 07 Nov, 2020
Reviewer #1 agreed
On 07 Nov, 2020
Editor assigned
On 18 Jul, 2020
Submission checks complete
On 09 Jun, 2020
First submitted
On 27 Apr, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Bariatric surgery is an effective approach to weight loss and long-term comorbidity resolution. Although recommended in several guidelines, supervised exercise has not been systematically prescribed after bariatric surgery. The aim of this study is to determine the effects of two types of exercise, moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT), on body composition, cardiopulmonary function and perceived quality of life in bariatric surgery patients.
Methods: This randomized controlled exploratory pilot trial will include 75 adults of both sexes scheduled for bariatric surgery. They will be randomly assigned to one of three groups: 1) MICT, 2) HIIT, or 3) a control group. The intervention will occur 2 days a week for 4 months. Outcomes will be assessed at four points: 1) one week before surgery; 2) 21 days after surgery (baseline before the exercise program); 3) 8 weeks after beginning the exercise program; and 4) one week after the end of intervention. Primary outcomes will include body composition, heart rate variability, and six-minute walk test and quality of life scores. Secondary outcomes will be maximal respiratory pressure, flowmeter, hand dynamometry, and 30-second sit-to-stand test results.
Discussion: Both exercise protocols in this study were developed according to evidence-based practice. It is expected that, after 16 weeks of intervention, body composition (measured by electrical bioimpedance), cardiopulmonary function (measured by heart rate variability, maximal inspiratory pressure, maximal expiratory pressure, peak expiratory flow, handgrip strength, and the six-minute walk test) and perceived quality of life (measured by the Moorehead-Ardelt quality of life questionnaire II and bariatric analysis and reporting outcome system scores) will improve, especially in the HIIT group.
Trial registration: ClinicalTrials.gov, NCT04235842, registered 22 January 2020.
Figure 1
Figure 2