Sit Less, Interact, Move More (SLIMM) Intervention Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in level of light physical activity, measured in minutes per day
研究概览
简要总结
In the past two decades, the prevalence of obesity in the US has increased from 23.2% to 32.9%. This epidemic is fueling the Chronic Kidney Disease (CKD) epidemic. This likely is the major challenge facing the nephrology community in the next decade and beyond. This pilot study is designed to test the feasibility of the Sit Less, Interact, Move More (SLIMM) intervention and to determine its preliminary impact on light physical activity (PA) levels. Increasing light PA may have significant impact on both obesity and slowing the progression of CDK.
详细描述
More than one-third of U.S. adults (35.7%) are obese (body mass index (BMI) > 30 kg/m2). In 2008, medical costs associated with obesity were estimated at $147 billion. Furthermore, there is a graded association of BMI and the risk of end stage renal disease (ESRD). Indeed, increasing prevalence of CKD in the US population is partly explained by increasing BMI. Hence, as a public health policy, it is imperative that obesity be targeted in order to decrease the morbidity, mortality and the healthcare costs burden associated with CKD and ESRD.
Physical inactivity plays a major role in obesity. Volitional exercise (VE), which includes moderate to vigorous physical activities (MVPA) such as sports and fitness-related activities, and non-volitional exercise, which includes low to light intensity physical activity (PA) such as activities of daily living, fidgeting, spontaneous muscle contraction, and maintaining posture in non-recumbent positions, represent two different ends of the PA spectrum. The current national recommendations are focused on MVPA (30 minutes of moderate PA five times a week or 25 minutes of vigorous activities three times a week). However, the relative importance of low and light activities and MVPA has not been established. As described in the preliminary data, the analyses of objectively measured PA in National Health And Nutrition Examination Survey (NHANES) suggest that a larger amount of light intensity PA is strongly associated with lower odds of proteinuria, lower odds of CKD and a lower hazard of death at any given level of MVPA. Furthermore, there appears to be a threshold effect for MVPA with mortality that plateaus at about half of the currently recommended levels of MVPA. Since physical function in the CKD population is low, 30 minutes of moderate PA five times a week or 25 minutes of vigorous activities three times a week might induce fatigue and paradoxically reduce light intensity PA. On the other hand, a lower target of MVPA might improve adherence with MVPA as well as not decrease light PA. This pilot intervention study will test the efficacy, feasibility and tolerability of the SLIMM intervention. The results of this intervention will be later used to determine if targeting obesity via the SLIMM intervention will slow kidney disease progression.
DESIGN:
This is a pilot intervention study that will examine the feasibility of and adherence to the SLIMM intervention to increase levels of light physical activity
Baseline visit: Baseline PA data will be collected by accelerometer in the week following the screening visit. Participants will be instructed on the importance of physical activity, the recommendations of 150 min/wk of moderate PA, or 75 min/wk of vigorous PA, and be provided with examples of physical activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 95 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be willing to participate in all study procedures and meet the criteria for one of the three groups listed below.
- •Are currently receiving chronic maintenance dialysis
- •Have CKD (eGFR 20 to 45 ml/min/1.73 m2 or eGFR > 45 and < 60 ml/min/1.73 m2)
- •Individuals with eGFR >60 ml/min/1.73 m2
排除标准
- •Age less than 18 years
- •Pregnant women
- •Prisoners
- •Diagnosis of glomerulonephritis
- •Life expectancy less than 1 year
- •Expected to undergo renal replacement therapy within 1 year
- •Enrolled in interventional trials using drugs or devices
- •Physical mobility limitations that preclude physical activity interventions
- •Individuals who are wheelchair bound, reliant on a walker or crutches for ambulation
- •Patients who self-report MVOA greater than 150 min/week or more
结局指标
主要结局
Change in level of light physical activity, measured in minutes per day
时间窗: baseline to 18 weeks
Determine the effect of SLIMM intervention as measured by the change in levels of light physical activity, measured by accelerometer
次要结局
未报告次要终点
研究者
Srinvasan Beddhu
MD
University of Utah
