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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bariatric Surgery Patients

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center 3-parallel-arm open-label randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance group<br>16 weeks of resistance exercise-training. | Other: Exercise<br>* 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.<br>|
| Experimental: Endurance group<br>16 weeks of endurance exercise-training. | Other: Exercise<br>* 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.<br>|
| No Intervention: Control group<br>Does not enrole in exercise-training programme. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent fat mass | Change in fat mass percentage measured by DXA at 0 and 16 weeks (pre and post intervention) | 16 weeks | 
| Resting metabolic rate | Change in resting metabolic rate measured by indirect calorimetry at 0 and 16 weeks (pre and post intervention) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Threshold lumbar paraspinal | Change in Pressure Pain Threshold at 0 and 16 weeks (pre and post intervention) | 16 weeks | 
| Lean body mass | Change in lean body mass measured by DXA at 0 and 16 weeks (pre and post intervention) | 16 weeks | 
| 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) | 16 weeks | 
| 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) | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, Resistance exercise, Resting metabolic rate