Reducing Sedentary Time in Post-bariatric Patients: The Take a STAND for Health Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Change from baseline to follow-up on sedentary behaviour
研究概览
简要总结
This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in post-bariatric patients. To this aim, we will conduct a crossover trial and a randomized controlled trial. The crossover trial aims to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition. The 4-month parallel-group randomized controlled trials aim to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light- (or very light-) intensity physical activity in these patients. A multitude of gold-standard techniques will be applied to evaluate the effects of the intervention on several outcomes, including sedentary time (primary outcome), physical activity levels, clinical parameters specific to each condition, cardiometabolic risk factors, immune function, and health-related quality of life.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women aged 20 to 50 years with BMI ≥ 35 kg / m2 and associated comorbidities, or BMI ≥ 40 kg / m2 who are about to undergo Roux-en-Y gastric bypass surgery at the Metabolic and Bariatric Surgery Unit of the Faculty of Medicine.
排除标准
- •Exclusion criteria will involve sedentary time (sitting / reclining) <8 hours per day; anemia; hypothyroidism; current malignancy or history of cancer within the past 5 years; cardiovascular disease; neurological disorders; any physical disabilities that could hamper physical testing; and being physically active (i.e., participation in ≥ 150 minutes per week of moderate-to-vigorous physical activity in bouts of ≥ 10 minutes, or ≥ 75 minutes per week of vigorous-intensity physical activity).
结局指标
主要结局
Change from baseline to follow-up on sedentary behaviour
时间窗: 4 months
Sedentary behaviour will be assessed by ActivPAL™
次要结局
- Change from baseline to follow-up on quality of life(4 months)
- Change from baseline to follow-up on food intake(4 months)
- Change from baseline to follow-up on physical activity levels(4 months)
- Change from baseline to follow-up on aerobic capacity(4 months)
- Change from baseline to follow-up on autonomic function(4 months)
- Change from baseline to follow-up on body composition(4 months)
- Change from baseline to follow-up on cardiovascular risk score(4 months)
- Change from baseline to follow-up on sleep apnea(4 months)
- Change from baseline to follow-up on office and ambulatory blood pressure(4 months (RCT) and 5 hours (crossover))
- Change from baseline to follow-up on functional capacity and fatigue(4 months)
- Change from baseline to follow-up on cardiovascular and respiratory chemoreflex control(4 months)
研究者
Bruno Gualano
Associate Professor
University of Sao Paulo