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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percent fat mass
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Already taking part in a structured exercise programme.
- •Presenting health condition contraindicating exercise practice
- •Inability to commit with intervention
结局指标
主要结局
Percent fat mass
时间窗: 16 weeks
Change in fat mass percentage measured by DXA at 0 and 16 weeks (pre and post intervention)
Resting metabolic rate
时间窗: 16 weeks
Change in resting metabolic rate measured by indirect calorimetry at 0 and 16 weeks (pre and post intervention)
次要结局
- Pressure Pain Threshold lumbar paraspinal(16 weeks)
- Lean body mass(16 weeks)
- Spine mobility, posture and stability(16 weeks)
- Trunk muscle strength(16 weeks)
研究者
Tiago Montanha
MsC Principal Investigator
Universidade do Porto