End-Stage Renal Disease Intra-dialysis Lifestyle Education Study

End-stage Renal Disease Clinical Trial

— END-IDLE  

Official title:

End-Stage Renal Disease Intra-dialysis Lifestyle Education Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361268
• Other study ID #: 141325
• Secondary ID: K23AT006965
• Status: Completed
• Phase: N/A
• First received: January 29, 2015
• Last updated: July 13, 2017
• Start date: July 2015
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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.
• 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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional Assessment of Chronic Illness Therapy-Fatigue	Questionnaire to assess fatigue among chronic disease patients	Baseline, 6, 12, and 24 weeks
Secondary	Profile of Mood States	Questionnaire to assess emotional states	Baseline, 6, 12, and 24 weeks
Secondary	Center for Epidemiological Studies Depression	Questionnaire to assess depressive symptoms	Baseline, 6, 12, and 24 weeks
Secondary	End-stage renal disease: Patient satisfaction	Questionnaire to assess patient satisfaction with dialysis treatment	Baseline, 6, 12, and 24 weeks
Secondary	Pittsburgh Sleep Quality Index	Questionnaire to assess sleep quality	Baseline, 6, 12, and 24 weeks
Secondary	Self-efficacy for self-management	Questionnaire to assess self-efficacy for self-management	Baseline, 6, 12, and 24 weeks
Secondary	6-minute walk test	Assessment of physical performance	Baseline, 12, and 24 weeks
Secondary	Blood pressure		Baseline and weekly over 12 week study period
Secondary	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	Baseline and 12-weeks
Secondary	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	Baseline and 12-weeks
Secondary	Autonomic tone	Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability	Baseline and 12-weeks