Clinical trial NCT02361268: End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
Official title: End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Keywords: end-stage renal disease
hemodialysis
yoga
mind-body medicine
meditation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-02-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks.
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks
Secondary outcomes:
measure: Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: Baseline, 6, 12, and 24 weeks
measure: Profile of Mood States
timeFrame: Baseline, 6, 12, and 24 weeks
measure: Center for Epidemiological Studies Depression
timeFrame: Baseline, 6, 12, and 24 weeks
measure: End-stage renal disease: Patient satisfaction
timeFrame: Baseline, 6, 12, and 24 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 6, 12, and 24 weeks
measure: Self-efficacy for self-management
timeFrame: Baseline, 6, 12, and 24 weeks
measure: 6-minute walk test
timeFrame: Baseline, 12, and 24 weeks
measure: Blood pressure
timeFrame: Baseline and weekly over 12 week study period
measure: Measure of endothelial function with flow-mediated vasodilatation
timeFrame: Baseline and 12-weeks
measure: Measure of arterial stiffness from radial artery based pulse wave analysis
timeFrame: Baseline and 12-weeks
measure: Autonomic tone
timeFrame: Baseline and 12-weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Gurjeet S Birdee, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: