End-Stage Renal Disease Intra-dialysis Lifestyle Education Study (END-IDLE)

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 Overview

• Status: Completed
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Behavioral: Intradialysis-yoga; Behavioral: Educational program

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-dialysis yoga; The experimental intervention in this study is intra-dialysis yoga.	Behavioral: Intradialysis-yoga; 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.
Active Comparator: Educational program; The active comparator for the study is an educational program.	Behavioral: Educational program; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 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.	Baseline, 6 weeks, 12 weeks, and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Chronic Illness Therapy-Fatigue	Questionnaire to assess fatigue among chronic disease patients	Baseline, 6, 12, and 24 weeks
Profile of Mood States	Questionnaire to assess emotional states	Baseline, 6, 12, and 24 weeks
Center for Epidemiological Studies Depression	Questionnaire to assess depressive symptoms	Baseline, 6, 12, and 24 weeks
End-stage renal disease: Patient satisfaction	Questionnaire to assess patient satisfaction with dialysis treatment	Baseline, 6, 12, and 24 weeks
Pittsburgh Sleep Quality Index	Questionnaire to assess sleep quality	Baseline, 6, 12, and 24 weeks
Self-efficacy for self-management	Questionnaire to assess self-efficacy for self-management	Baseline, 6, 12, and 24 weeks
6-minute walk test	Assessment of physical performance	Baseline, 12, and 24 weeks
Blood pressure		Baseline and weekly over 12 week study period
Measure of endothelial function with flow-mediated vasodilatation	Sub-set of patients will have this assessment of endothelial function which measures percentage change in diameter measured in millimeters	Baseline and 12-weeks
Measure of arterial stiffness from radial artery based pulse wave analysis	Sub-set of patient will have this assessment of arterial stiffness as augmentation index	Baseline and 12-weeks
Autonomic tone	Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability	Baseline and 12-weeks

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Gurjeet S Birdee, MD MPH, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 11, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: meditation; yoga; end-stage renal disease; hemodialysis; mind-body medicine
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 141325; K23AT006965 (U.S. NIH Grant/Contract)