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

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intradialysis-yoga
Educational program
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring end-stage renal disease, hemodialysis, yoga, mind-body medicine, meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intra-dialysis yoga

Educational program

Arm Description

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

The active comparator for the study is an educational program.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional Assessment of Chronic Illness Therapy-Fatigue
Questionnaire to assess fatigue among chronic disease patients
Profile of Mood States
Questionnaire to assess emotional states
Center for Epidemiological Studies Depression
Questionnaire to assess depressive symptoms
End-stage renal disease: Patient satisfaction
Questionnaire to assess patient satisfaction with dialysis treatment
Pittsburgh Sleep Quality Index
Questionnaire to assess sleep quality
Self-efficacy for self-management
Questionnaire to assess self-efficacy for self-management
6-minute walk test
Assessment of physical performance
Blood pressure
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
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
Autonomic tone
Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability

Full Information

First Posted
January 29, 2015
Last Updated
July 13, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02361268
Brief Title
End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
Acronym
END-IDLE
Official Title
End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
end-stage renal disease, hemodialysis, yoga, mind-body medicine, meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-dialysis yoga
Arm Type
Experimental
Arm Description
The experimental intervention in this study is intra-dialysis yoga.
Arm Title
Educational program
Arm Type
Active Comparator
Arm Description
The active comparator for the study is an educational program.
Intervention Type
Behavioral
Intervention Name(s)
Intradialysis-yoga
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational program
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks.
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks, and 24 weeks
Secondary Outcome Measure Information:
Title
Functional Assessment of Chronic Illness Therapy-Fatigue
Description
Questionnaire to assess fatigue among chronic disease patients
Time Frame
Baseline, 6, 12, and 24 weeks
Title
Profile of Mood States
Description
Questionnaire to assess emotional states
Time Frame
Baseline, 6, 12, and 24 weeks
Title
Center for Epidemiological Studies Depression
Description
Questionnaire to assess depressive symptoms
Time Frame
Baseline, 6, 12, and 24 weeks
Title
End-stage renal disease: Patient satisfaction
Description
Questionnaire to assess patient satisfaction with dialysis treatment
Time Frame
Baseline, 6, 12, and 24 weeks
Title
Pittsburgh Sleep Quality Index
Description
Questionnaire to assess sleep quality
Time Frame
Baseline, 6, 12, and 24 weeks
Title
Self-efficacy for self-management
Description
Questionnaire to assess self-efficacy for self-management
Time Frame
Baseline, 6, 12, and 24 weeks
Title
6-minute walk test
Description
Assessment of physical performance
Time Frame
Baseline, 12, and 24 weeks
Title
Blood pressure
Time Frame
Baseline and weekly over 12 week study period
Title
Measure of endothelial function with flow-mediated vasodilatation
Description
Sub-set of patients will have this assessment of endothelial function which measures percentage change in diameter measured in millimeters
Time Frame
Baseline and 12-weeks
Title
Measure of arterial stiffness from radial artery based pulse wave analysis
Description
Sub-set of patient will have this assessment of arterial stiffness as augmentation index
Time Frame
Baseline and 12-weeks
Title
Autonomic tone
Description
Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability
Time Frame
Baseline and 12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gurjeet S Birdee, MD MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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End-Stage Renal Disease Intra-dialysis Lifestyle Education Study

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