Heart FailureNCT06434168
Impact of Yoga on Cognitive Function
A study testing Yoga intervention in people with Heart Failure and Mild Cognitive Impairment, run by Auburn University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Heart Failure, Mild Cognitive Impairment
- What is being tested?
- Yoga intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55 years and older
- Confirmed heart failure diagnosis with mild cognitive impairment
- New York Heart Association functional class II-IV
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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).
- Conditions
- Heart Failure, Mild Cognitive Impairment
- Being tested
- Yoga intervention, Control condition
- Keywords
- Yoga intervention, cognitive function
- Medical subject headings
- Heart Failure, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga interventionBehavioural
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.
Control conditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga intervention | Experimental | Not described Receives: Behavioral: Yoga intervention |
| Control condition | Placebo comparator | Not described Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structure
Using structural magnetic resonance imaging to examine brain structure between intervention and control groups. Less brain alteration is optimal.
Measured: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Brain functional connectivity
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.
Measured: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Cognitive function
Using cognitive tests to examine cognitive function and performance between intervention and control groups. A higher score on cognitive tests indicates better cognitive function.
Measured: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Serum brain-derived neurotrophic factor
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.
Measured: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start16 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Edward Via College of Osteopathic Medicine, Auburn campus
- Responsible party
- Principal investigator, Chin-Yen Lin, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434168
- Sponsor's protocol ID
- AU-24-001
- Status last verified
- Sep 2025
- First submitted
- 21 May 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Study of a Yoga Intervention in Heart Failure Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06434168
- Acronym / sponsor ID
- AU-24-001
- Conditions
- Heart Failure, Mild Cognitive Impairment
- Keywords
- Yoga intervention, cognitive function
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Edward Via College of Osteopathic Medicine, Auburn campus
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 May 2024 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga intervention | Experimental | Behavioral: Yoga intervention |
| Control condition | Placebo comparator | Behavioral: Control condition |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 55 years and older
- Confirmed heart failure diagnosis with mild cognitive impairment
- New York Heart Association functional class II-IV
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Yoga interventionPatients 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. | Behavioural | Yoga intervention |
| Control conditionPatients 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. | Behavioural | Control condition |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga intervention in people with Heart Failure and Mild Cognitive Impairment, run by Auburn University 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 3 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Brain structure (time frame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.