End-stage Renal Disease
Conditions
Keywords
end-stage renal disease, hemodialysis, yoga, mind-body medicine, meditation
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.
Interventions
BEHAVIORALIntradialysis-yoga
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.
BEHAVIORALEducational program
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
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Profile of Mood States | Baseline, 6, 12, and 24 weeks | Questionnaire to assess emotional states |
| Center for Epidemiological Studies Depression | Baseline, 6, 12, and 24 weeks | Questionnaire to assess depressive symptoms |
| 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 |
| Self-efficacy for self-management | Baseline, 6, 12, and 24 weeks | Questionnaire to assess self-efficacy for self-management |
| Functional Assessment of Chronic Illness Therapy-Fatigue | Baseline, 6, 12, and 24 weeks | Questionnaire to assess fatigue among chronic disease patients |
| Blood pressure | Baseline and weekly over 12 week study period | — |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed