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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
67
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.
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
Vanderbilt University Medical Center
Nashville, Tennessee, United States
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.
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks
Functional Assessment of Chronic Illness Therapy-Fatigue
Questionnaire to assess fatigue among chronic disease patients
Time frame: Baseline, 6, 12, and 24 weeks
Profile of Mood States
Questionnaire to assess emotional states
Time frame: Baseline, 6, 12, and 24 weeks
Center for Epidemiological Studies Depression
Questionnaire to assess depressive symptoms
Time frame: Baseline, 6, 12, and 24 weeks
End-stage renal disease: Patient satisfaction
Questionnaire to assess patient satisfaction with dialysis treatment
Time frame: Baseline, 6, 12, and 24 weeks
Pittsburgh Sleep Quality Index
Questionnaire to assess sleep quality
Time frame: Baseline, 6, 12, and 24 weeks
Self-efficacy for self-management
Questionnaire to assess self-efficacy for self-management
Time frame: Baseline, 6, 12, and 24 weeks
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6-minute walk test
Assessment of physical performance
Time frame: Baseline, 12, and 24 weeks
Blood pressure
Time frame: 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
Time frame: 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
Time frame: Baseline and 12-weeks
Autonomic tone
Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability
Time frame: Baseline and 12-weeks