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Completed

NCT Number: NCT02361268

End-Stage Renal Disease Intra-dialysis Lifestyle Education Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intradialysis-yoga

Behavioral

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.

educational program

Behavioral

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

Primary outcomes

  1. Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks.

    Time frame: Baseline, 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.

Secondary outcomes

  1. Functional Assessment of Chronic Illness Therapy-Fatigue

    Time frame: Baseline, 6, 12, and 24 weeks

    Questionnaire to assess fatigue among chronic disease patients

  2. Profile of Mood States

    Time frame: Baseline, 6, 12, and 24 weeks

    Questionnaire to assess emotional states

  3. Center for Epidemiological Studies Depression

    Time frame: Baseline, 6, 12, and 24 weeks

    Questionnaire to assess depressive symptoms

  4. End-stage renal disease: Patient satisfaction

    Time frame: Baseline, 6, 12, and 24 weeks

    Questionnaire to assess patient satisfaction with dialysis treatment

  5. Pittsburgh Sleep Quality Index

    Time frame: Baseline, 6, 12, and 24 weeks

    Questionnaire to assess sleep quality

  6. Self-efficacy for self-management

    Time frame: Baseline, 6, 12, and 24 weeks

    Questionnaire to assess self-efficacy for self-management

  7. 6-minute walk test

    Time frame: Baseline, 12, and 24 weeks

    Assessment of physical performance

  8. Blood pressure

    Time frame: Baseline and weekly over 12 week study period

  9. Measure of endothelial function with flow-mediated vasodilatation

    Time frame: Baseline and 12-weeks

    Sub-set of patients will have this assessment of endothelial function which measures percentage change in diameter measured in millimeters

  10. Measure of arterial stiffness from radial artery based pulse wave analysis

    Time frame: Baseline and 12-weeks

    Sub-set of patient will have this assessment of arterial stiffness as augmentation index

  11. Autonomic tone

    Time frame: Baseline and 12-weeks

    Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: END-IDLE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2015
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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