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Is Resistance Exercise More Effective Than Endurance in Reducing Obesity Relapse in Post-bariatric Surgery Patients (BariOptimize)

Primary Purpose

Bariatric Surgery Patients

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Exercise
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Patients focused on measuring Bariatric surgery, Resistance exercise, Resting metabolic rate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age between 18 and 65 years (until the end of intervention) Having performed primary bariatric surgery (gastric sleeve or RYGB methods) in the prior 18 to 24 months in S. João Hospital center. Willing to participate and commit to intervention Exclusion Criteria: Already taking part in a structured exercise programme. Presenting health condition contraindicating exercise practice Inability to commit with intervention

Sites / Locations

  • FADEUPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Resistance group

Endurance group

Control group

Arm Description

16 weeks of resistance exercise-training.

16 weeks of endurance exercise-training.

Does not enrole in exercise-training programme.

Outcomes

Primary Outcome Measures

Percent fat mass
Change in fat mass percentage measured by DXA at 0 and 16 weeks (pre and post intervention)
Resting metabolic rate
Change in resting metabolic rate measured by indirect calorimetry at 0 and 16 weeks (pre and post intervention)

Secondary Outcome Measures

Pressure Pain Threshold lumbar paraspinal
Change in Pressure Pain Threshold at 0 and 16 weeks (pre and post intervention)
Lean body mass
Change in lean body mass measured by DXA at 0 and 16 weeks (pre and post intervention)
Spine mobility, posture and stability
Change in spine mobility, posture and stability measured by algometer and Spinal Mouse and at 0 and 16 weeks (pre and post intervention)
Trunk muscle strength
Change in trunk muscle strength measured by dynamometry and expressed as peak torque relative to body weight at 0 and 16 weeks (pre and post intervention)

Full Information

First Posted
November 20, 2022
Last Updated
March 29, 2023
Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia, Research Centre in Physical Activity, Health and Leisure, Portugal, Laboratory for integrative and translational research in population health, Portugal
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1. Study Identification

Unique Protocol Identification Number
NCT05632718
Brief Title
Is Resistance Exercise More Effective Than Endurance in Reducing Obesity Relapse in Post-bariatric Surgery Patients
Acronym
BariOptimize
Official Title
Searching for the Optimal Exercise Training Regimen for Reducing Obesity Relapse in Post Bariatric Surgery Patients With Insufficient Weight Loss - BariOPTIMIZE Randomized Parallel-arm Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia, Research Centre in Physical Activity, Health and Leisure, Portugal, Laboratory for integrative and translational research in population health, Portugal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to compare the effects of resistance exercise and endurance in post-bariatric surgery patients with insuficcient weight loss. The main question it aims to answer is: Is resistance exercise more effective than endurance exercise in preventing obesity relapse in post-bariatric surgery patients with insuficcient weight loss? Is resistance exercise more effective than endurance exercise in increasing resting metabolic rate in post-bariatric surgery patients with insuficcient weight loss? Participants will be randomly assigned to one of the following groups: Resistance group: performing resistance exercise-training for 16 weeks Endurace group: performing endurance exercise-training for 16 weeks Control group: no intervention / standard medical care
Detailed Description
As lean body mass losses following bariatric surgery (BS) negatively affect resting metabolic rate (RMR), metabolic regulation and physical function, the researchers hypothesize that resistance exercise (REx) could more effectively prevent obesity relapse following BS. Also, the increased mechanical loading on lumbar spine intervertebral discs is associated with an ampered spinal health and low pressure pain threshold sensitvity in these patients. The main purpose of this project is to determine which exercise mode is best suited to prevent obesity and increase RMR of post-BS patients with insufficient weight loss. To accomplish this, the researchers will perform a single center 3-parallel-arm open-label randomized clinical trial to determine if resistance exercise is superior to endurance exercise in reducing obesity relapse in post-BS patients with insufficient weight loss. Aditionally we aim to investigate if resistance exercise is more effective than endurance exercise in producing changes in pressure pain threshold, spine mobility and thoracolumbar strength in post-BS patients with insufficient weight loss. Patients will be enrolled in 4 (possibly 5) consecutive cohorts of n=20. These must be between 18 and 65 years old and have performed bariatric surgery in the prior 18 to 24 months. Participants will be randomly assigned one of three groups: control (CON), resistance exercise (REx) and endurance exercise (EEx), while the latter two will be enrolling exercise-training programs. All the groups will be assessed in two moments: baseline and 16 weeks (end of exercise programme). Both the training sessions and the assessments will be performed at Porto Faculty of Sports (FADEUP). The study is expected to run for 2.5 years while including 5 cohorts of patients. Participants will be the chance to participate for free in exercise sessions (REx, EEx ) and to have free access to the results of health evaluations performed. Main risks for participants in the study will be the potential adverse events associated with exercise or physical evaluations and the burden of time spent in exercise sessions and evaluations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Patients
Keywords
Bariatric surgery, Resistance exercise, Resting metabolic rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center 3-parallel-arm open-label randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance group
Arm Type
Experimental
Arm Description
16 weeks of resistance exercise-training.
Arm Title
Endurance group
Arm Type
Experimental
Arm Description
16 weeks of endurance exercise-training.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Does not enrole in exercise-training programme.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Resistance and endurance supervised exercise-training. The training programme will last for 16 weeks. Training sessions will be held at Porto Faculty of Sports, 3 times per week with the duration of 1 hour.
Primary Outcome Measure Information:
Title
Percent fat mass
Description
Change in fat mass percentage measured by DXA at 0 and 16 weeks (pre and post intervention)
Time Frame
16 weeks
Title
Resting metabolic rate
Description
Change in resting metabolic rate measured by indirect calorimetry at 0 and 16 weeks (pre and post intervention)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold lumbar paraspinal
Description
Change in Pressure Pain Threshold at 0 and 16 weeks (pre and post intervention)
Time Frame
16 weeks
Title
Lean body mass
Description
Change in lean body mass measured by DXA at 0 and 16 weeks (pre and post intervention)
Time Frame
16 weeks
Title
Spine mobility, posture and stability
Description
Change in spine mobility, posture and stability measured by algometer and Spinal Mouse and at 0 and 16 weeks (pre and post intervention)
Time Frame
16 weeks
Title
Trunk muscle strength
Description
Change in trunk muscle strength measured by dynamometry and expressed as peak torque relative to body weight at 0 and 16 weeks (pre and post intervention)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18 and 65 years (until the end of intervention) Having performed primary bariatric surgery (gastric sleeve or RYGB methods) in the prior 18 to 24 months in S. João Hospital center. Willing to participate and commit to intervention Exclusion Criteria: Already taking part in a structured exercise programme. Presenting health condition contraindicating exercise practice Inability to commit with intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiago L Montanha, MSc
Phone
(+351) 918913418
Email
lmontanha@fade.up.pt
First Name & Middle Initial & Last Name or Official Title & Degree
Hélder R Fonseca, PhD
Email
hfonseca@fade.up.pt
Facility Information:
Facility Name
FADEUP
City
Porto
ZIP/Postal Code
4200-450
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélder R Fonseca, PhD
Email
hfonseca@fade.up.pt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Is Resistance Exercise More Effective Than Endurance in Reducing Obesity Relapse in Post-bariatric Surgery Patients

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