NCT02361268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

January 29, 2015

Last Update Submit

July 13, 2017

Conditions

End-stage Renal Disease

Keywords

end-stage renal diseasehemodialysisyogamind-body medicinemeditation

Outcome Measures

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.

    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 Outcomes (11)

  • Functional Assessment of Chronic Illness Therapy-Fatigue

    Baseline, 6, 12, and 24 weeks

  • Profile of Mood States

    Baseline, 6, 12, and 24 weeks

  • Center for Epidemiological Studies Depression

    Baseline, 6, 12, and 24 weeks

  • End-stage renal disease: Patient satisfaction

    Baseline, 6, 12, and 24 weeks

  • Pittsburgh Sleep Quality Index

    Baseline, 6, 12, and 24 weeks

  • +6 more secondary outcomes

Study Arms (2)

Intra-dialysis yoga

EXPERIMENTAL

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

Behavioral: Intradialysis-yoga

Educational program

ACTIVE COMPARATOR

The active comparator for the study is an educational program.

Behavioral: Educational program

Interventions

Intradialysis-yogaBEHAVIORAL

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.

Intra-dialysis yoga
Educational programBEHAVIORAL

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

Educational program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • 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.

    PMID: 37651553DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gurjeet S Birdee, MD MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 11, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations

US(1)