Nashville, Tennessee 37232


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02361268


Primary Contact:

Principal Investigator
Gurjeet S Birdee, MD MPH
Vanderbilt University

Sujata Ghosh, MPH
Email: Sujata.Ghosh@vanderbilt.edu


Backup Contact:

Email: gurjeet.birdee@vanderbilt.edu
Gurjeet S Birdee, MD MPH


Location Contact:

Nashville, Tennessee 37232
United States

Sujata Ghosh, MPH
Phone: 615-936-8489
Email: Sujata.Ghosh@vanderbilt.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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