End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks.
研究概览
简要总结
The purpose of this study is to compare the effects of intra-dialysis yoga to an educational program among patients with end-stage renal disease. The investigators hypothesize that yoga as compared to the educational program will significantly improve quality of life.
详细描述
The investigators propose a prospective, randomized clinical trial among on maintenance hemodialysis to compare the effects of intra-dialysis yoga to an educational program. In a sample of 68 patients the investigators will compare the clinical effects of a 12-week program of yoga to a 12-week education program during dialysis. Outcome assessment of study participants will occur at baseline, 6-weeks, 12-weeks, and 24 weeks for: disease-related quality of life (physical component primary outcome of the study), physical performance, blood pressure, fatigue, satisfaction with dialysis, sleep quality, and mood. Among a sub-sample of 20 participants, the investigators will measure the potential effects of the interventions on endothelial function, arterial stiffness, and autonomic tone. The sub-study will collect outcomes at baseline and 12 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maintenance hemodialysis for ≥3 or months
- •Adequately dialyzed (Kt/V ≥1.2 measured within last 3 months)
- •Expected to remain in present hemodialysis shift for next 4 months
- •Expected to remain on hemodialysis for at least 6 months
- •18 years or older
排除标准
- •Acute or chronic medical conditions that would make intra-dialysis yoga potentially hazardous
- •Unstable cardiac disease e.g. angina, life threatening arrhythmia
- •Chronic lung disease that prevents gentle exercise or deep breathing exercises
- •Active cerebrovascular disease
- •Major depression
- •Chronic symptoms of nausea, vomiting, or diarrhea
- •Current participation in exercise or mind body program/practice
- •Cognitive impairment (MME ≤ 24) measured at baseline testing visit
研究组 & 干预措施
Intra-dialysis yoga
The experimental intervention in this study is intra-dialysis yoga.
干预措施: Intradialysis-yoga (Behavioral)
Educational program
The active comparator for the study is an educational program.
干预措施: Educational program (Behavioral)
结局指标
主要结局
Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks.
时间窗: Baseline, 6 weeks, 12 weeks, and 24 weeks
The Kidney Disease Quality of Life-36 instrument is a 36-item instrument that contains a generic core (Short Form-12) plus the burden of kidney disease, symptoms/problem of kidney disease, and effects of kidney disease scales.
次要结局
- Functional Assessment of Chronic Illness Therapy-Fatigue(Baseline, 6, 12, and 24 weeks)
- Profile of Mood States(Baseline, 6, 12, and 24 weeks)
- End-stage renal disease: Patient satisfaction(Baseline, 6, 12, and 24 weeks)
- Pittsburgh Sleep Quality Index(Baseline, 6, 12, and 24 weeks)
- Measure of endothelial function with flow-mediated vasodilatation(Baseline and 12-weeks)
- Center for Epidemiological Studies Depression(Baseline, 6, 12, and 24 weeks)
- Self-efficacy for self-management(Baseline, 6, 12, and 24 weeks)
- Blood pressure(Baseline and weekly over 12 week study period)
- Autonomic tone(Baseline and 12-weeks)
- 6-minute walk test(Baseline, 12, and 24 weeks)
- Measure of arterial stiffness from radial artery based pulse wave analysis(Baseline and 12-weeks)
研究者
Gurjeet Birdee
Assistant Professor
Vanderbilt University Medical Center