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Clinical Trials/NCT05632718
NCT05632718
Recruiting
Not Applicable

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

Universidade do Porto1 site in 1 country100 target enrollmentDecember 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery Patients
Sponsor
Universidade do Porto
Enrollment
100
Locations
1
Primary Endpoint
Percent fat mass
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2022
End Date
April 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tiago Montanha

MsC Principal Investigator

Universidade do Porto

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

Outcomes

Primary Outcomes

Percent fat mass

Time Frame: 16 weeks

Change in fat mass percentage measured by DXA at 0 and 16 weeks (pre and post intervention)

Resting metabolic rate

Time Frame: 16 weeks

Change in resting metabolic rate measured by indirect calorimetry at 0 and 16 weeks (pre and post intervention)

Secondary Outcomes

  • Pressure Pain Threshold lumbar paraspinal(16 weeks)
  • Lean body mass(16 weeks)
  • Spine mobility, posture and stability(16 weeks)
  • Trunk muscle strength(16 weeks)

Study Sites (1)

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