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 |
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.
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.
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
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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