End-Stage Renal Disease Intra-dialysis Lifestyle Education Study

NCT ID: NCT02361268

Last Updated: 2017-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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End-stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intra-dialysis yoga

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

Group Type EXPERIMENTAL

Intradialysis-yoga

Intervention Type 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

The active comparator for the study is an educational program.

Group Type ACTIVE_COMPARATOR

Educational program

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Gurjeet Birdee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gurjeet S Birdee, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

Reference Type DERIVED
PMID: 37651553 (View on PubMed)

Other Identifiers

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K23AT006965

Identifier Type: NIH

Identifier Source: secondary_id

View Link

141325

Identifier Type: -

Identifier Source: org_study_id

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