End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
- Conditions
- End-stage Renal Disease
- Interventions
- Behavioral: Educational programBehavioral: Intradialysis-yoga
- Registration Number
- NCT02361268
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Educational program Educational program The active comparator for the study is an educational program. Intra-dialysis yoga Intradialysis-yoga The experimental intervention in this study is intra-dialysis yoga.
- Primary Outcome Measures
Name Time Method Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks. 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.
- Secondary Outcome Measures
Name Time Method Functional Assessment of Chronic Illness Therapy-Fatigue Baseline, 6, 12, and 24 weeks Questionnaire to assess fatigue among chronic disease patients
Profile of Mood States Baseline, 6, 12, and 24 weeks Questionnaire to assess emotional states
End-stage renal disease: Patient satisfaction Baseline, 6, 12, and 24 weeks Questionnaire to assess patient satisfaction with dialysis treatment
Pittsburgh Sleep Quality Index Baseline, 6, 12, and 24 weeks Questionnaire to assess sleep quality
Measure of endothelial function with flow-mediated vasodilatation Baseline and 12-weeks Sub-set of patients will have this assessment of endothelial function which measures percentage change in diameter measured in millimeters
Center for Epidemiological Studies Depression Baseline, 6, 12, and 24 weeks Questionnaire to assess depressive symptoms
Self-efficacy for self-management Baseline, 6, 12, and 24 weeks Questionnaire to assess self-efficacy for self-management
Blood pressure Baseline and weekly over 12 week study period Autonomic tone Baseline and 12-weeks Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability
6-minute walk test Baseline, 12, and 24 weeks Assessment of physical performance
Measure of arterial stiffness from radial artery based pulse wave analysis Baseline and 12-weeks Sub-set of patient will have this assessment of arterial stiffness as augmentation index
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States