- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06434168
Impact of Yoga on Cognitive Function
April 1, 2026 updated by: Chin-Yen Lin, Auburn University
A Pilot and Feasibility Study of a Yoga Intervention in Heart Failure Patients With Mild Cognitive Impairment
Mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life.
While yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown.
Therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
A prospective, 2-arm comparative feasibility design will be used.
The investigators will enroll 24 patients with a confirmed heart failure diagnosis with mild cognitive impairment.
Patients will be randomized equally into yoga intervention or control group.
Patients in the yoga intervention group will receive a 60-minute yoga session twice per week for 12-week.
Survey, cognitive function data, MRI scans, and blood samples will be collected at baseline and at 3 months (after completion of yoga intervention).
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Auburn, Alabama, United States, 36849
- Auburn University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 55 years and older
- Confirmed heart failure diagnosis with mild cognitive impairment
- New York Heart Association functional class II-IV
Exclusion Criteria:
- Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses
- Have implanted defibrillator, left ventricular assist device placement or cardiac transplant
- Have any other implanted metals that interfere with the MRI magnetic field for patient safety
- Substance abuse
- Pregnant
- Unable to perform yoga due to physical limitations or severity of illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control condition
|
Patients in the control group will receive care-as-usual from their healthcare providers and will be asked to avoid engaging in yoga during their 3 months in the study.
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Experimental: Yoga intervention
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Patients in the yoga group will receive a 60-minute session, twice per week over 12 weeks for a total of 24 sessions.
Each yoga session consists of a warm-up, yoga postures standing or seated depending on the capability of the patient, and relaxation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain structure
Time Frame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
|
Using structural magnetic resonance imaging to examine brain structure between intervention and control groups.
Less brain alteration is optimal.
|
Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
|
|
Brain functional connectivity
Time Frame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
|
Functional magnetic resonance imaging is used to examine functional connectivity between intervention and control groups.
A balance of activity across different brain regions is optimal.
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Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
|
|
Cognitive function
Time Frame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
|
Using cognitive tests to examine cognitive function and performance between intervention and control groups.
A higher score on cognitive tests indicates better cognitive function.
|
Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
|
|
Serum brain-derived neurotrophic factor
Time Frame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
|
A blood sample will be obtained using phlebotomy to measure the levels of serum brain-derived neurotrophic factor and reported in pg/mL.
Higher concentrations are optimal.
|
Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
May 21, 2024
First Submitted That Met QC Criteria
May 23, 2024
First Posted (Actual)
May 30, 2024
Study Record Updates
Last Update Posted (Actual)
April 6, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU-24-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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