End-Stage Renal Disease Intra-dialysis Lifestyle Education Study



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:7/8/2016
Start Date:July 2015
End Date:May 2017
Contact:Sujata Ghosh, MPH
Email:Sujata.Ghosh@vanderbilt.edu

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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.

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.

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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Gurjeet S Birdee, MD, MPH
Phone: 615-936-8489
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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