Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT02361268
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Time frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess fatigue among chronic disease patients
Time frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess emotional states
Time frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess depressive symptoms
Time frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess patient satisfaction with dialysis treatment
Time frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess sleep quality
Time frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess self-efficacy for self-management
Time frame: Baseline, 12, and 24 weeks
Assessment of physical performance
Time frame: Baseline and weekly over 12 week study period
Time frame: Baseline and 12-weeks
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
Sub-set of patient will have this assessment of arterial stiffness as augmentation index
Time frame: Baseline and 12-weeks
Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability
Vanderbilt University Medical Center
Other
Acronym: END-IDLE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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