End-Stage Renal Disease Intra-dialysis Lifestyle Education Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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End-Stage Renal Disease Intra-dialysis Lifestyle Education Study

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Behavioral: Intradialysis-yoga
* Behavioral: Educational program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-dialysis yoga<br>The experimental intervention in this study is intra-dialysis yoga. | Behavioral: Intradialysis-yoga<br>* The experimental intervention in this study is intra-dialysis yoga. The intra-dialysis yoga protocol consists of yoga instruction and practice being offered three times a week for 12 weeks. Subjects will have the opportunity to participate in 15 to 60 minutes of yoga during dialysis.<br>|
| Active Comparator: Educational program<br>The active comparator for the study is an educational program. | Behavioral: Educational program<br>* The educational intervention in this study consists of 12 modules of an educational course, Kidney School, developed and maintained by the Medical Education Institute, Inc. Kidney School is a comprehensive, free, educational curriculum for people with kid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 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. | Baseline, 6 weeks, 12 weeks, and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Chronic Illness Therapy-Fatigue | Questionnaire to assess fatigue among chronic disease patients | Baseline, 6, 12, and 24 weeks | 
| Profile of Mood States | Questionnaire to assess emotional states | Baseline, 6, 12, and 24 weeks | 
| Center for Epidemiological Studies Depression | Questionnaire to assess depressive symptoms | Baseline, 6, 12, and 24 weeks | 
| End-stage renal disease: Patient satisfaction | Questionnaire to assess patient satisfaction with dialysis treatment | Baseline, 6, 12, and 24 weeks | 
| Pittsburgh Sleep Quality Index | Questionnaire to assess sleep quality | Baseline, 6, 12, and 24 weeks | 
| Self-efficacy for self-management | Questionnaire to assess self-efficacy for self-management | Baseline, 6, 12, and 24 weeks | 
| 6-minute walk test | Assessment of physical performance | Baseline, 12, and 24 weeks | 
| Blood pressure |  | Baseline and weekly over 12 week study period | 
| Measure of endothelial function with flow-mediated vasodilatation | Sub-set of patients will have this assessment of endothelial function which measures percentage change in diameter measured in millimeters | Baseline and 12-weeks | 
| Measure of arterial stiffness from radial artery based pulse wave analysis | Sub-set of patient will have this assessment of arterial stiffness as augmentation index | Baseline and 12-weeks | 
| Autonomic tone | Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability | Baseline and 12-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-stage renal disease, hemodialysis, yoga, mind-body medicine, meditation