End-stage Renal DiseaseEND-IDLENCT02361268
End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
A study testing Intradialysis-yoga and Educational program in people with End-stage Renal Disease, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Intradialysis-yoga and Educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this 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.
Read the 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.
- Conditions
- End-stage Renal Disease
- Being tested
- Intradialysis-yoga, Educational program
- Keywords
- end-stage renal disease, hemodialysis, yoga, mind-body medicine, meditation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialysis-yogaBehavioural
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 programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intra-dialysis yoga | Experimental | The experimental intervention in this study is intra-dialysis yoga. Receives: Behavioral: Intradialysis-yoga |
| Educational program | Active comparator | The active comparator for the study is an educational program. Receives: Behavioral: Educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 12 weeks, and 24 weeks
Secondary outcomes (11)
Functional Assessment of Chronic Illness Therapy-Fatigue
Questionnaire to assess fatigue among chronic disease patients
Measured: Baseline, 6, 12, and 24 weeks
Profile of Mood States
Questionnaire to assess emotional states
Measured: Baseline, 6, 12, and 24 weeks
Center for Epidemiological Studies Depression
Questionnaire to assess depressive symptoms
Measured: Baseline, 6, 12, and 24 weeks
End-stage renal disease: Patient satisfaction
Questionnaire to assess patient satisfaction with dialysis treatment
Measured: Baseline, 6, 12, and 24 weeks
Pittsburgh Sleep Quality Index
Questionnaire to assess sleep quality
Measured: Baseline, 6, 12, and 24 weeks
Self-efficacy for self-management
Questionnaire to assess self-efficacy for self-management
Measured: Baseline, 6, 12, and 24 weeks
6-minute walk test
Assessment of physical performance
Measured: Baseline, 12, and 24 weeks
Blood pressure
Measured: Baseline and weekly over 12 week study period
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
Measured: Baseline and 12-weeks
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
Measured: Baseline and 12-weeks
Autonomic tone
Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Gurjeet Birdee, Vanderbilt University Medical Center
- Investigators
- Gurjeet S Birdee, MD MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361268
- Sponsor's protocol ID
- 141325
- Other IDs
- K23AT006965
- Acronym
- END-IDLE
- Status last verified
- Jul 2017
- First submitted
- 29 Jan 2015
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37651553
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
- ClinicalTrials.gov ID
- NCT02361268
- Acronym / sponsor ID
- END-IDLE / 141325
- Conditions
- End-stage Renal Disease
- Keywords
- end-stage renal disease, hemodialysis, yoga, mind-body medicine, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-dialysis yoga | Experimental | Behavioral: Intradialysis-yogaThe experimental intervention in this study is intra-dialysis yoga. |
| Educational program | Active comparator | Behavioral: Educational programThe active comparator for the study is an educational program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradialysis-yogaThe 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. | Behavioural | Intra-dialysis yoga |
| Educational programThe 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 | Behavioural | Educational program |
Primary outcome
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.
11 secondary outcomes
Functional Assessment of Chronic Illness Therapy-Fatigue
Time frame: Baseline, 6, 12, and 24 weeks
Profile of Mood States
Time frame: Baseline, 6, 12, and 24 weeks
Center for Epidemiological Studies Depression
Time frame: Baseline, 6, 12, and 24 weeks
End-stage renal disease: Patient satisfaction
Time frame: Baseline, 6, 12, and 24 weeks
Pittsburgh Sleep Quality Index
Time frame: Baseline, 6, 12, and 24 weeks
Self-efficacy for self-management
Time frame: Baseline, 6, 12, and 24 weeks
6-minute walk test
Time frame: Baseline, 12, and 24 weeks
Blood pressure
Time frame: Baseline and weekly over 12 week study period
Measure of endothelial function with flow-mediated vasodilatation
Time frame: Baseline and 12-weeks
Measure of arterial stiffness from radial artery based pulse wave analysis
Time frame: Baseline and 12-weeks
Autonomic tone
Time frame: Baseline and 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Derived from this study: PubMed 37651553Natale 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.
Related trials for End-stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gurjeet S Birdee, MD MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialysis-yoga and Educational program in people with End-stage Renal Disease, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.