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

Vanderbilt University Medical Center

Status: Completed

Conditions: End-stage Renal Disease

Treatments: Behavioral: Intradialysis-yoga; Behavioral: Educational program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02361268

141325

K23AT006965 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

67 participants in 2 patient groups

Intra-dialysis yoga

Experimental group

Description:

The experimental intervention in this study is intra-dialysis yoga.

Treatment:

Behavioral: Intradialysis-yoga

Educational program

Active Comparator group

Description:

The active comparator for the study is an educational program.

Treatment:

Behavioral: Educational program