Heart FailureForge AHEADNCT07489105
Forge AHEAD: Feasibility of Yoga to Improve Cognitive Function
A study testing Yoga group in people with Heart Failure and Rural Health, run by Auburn University at 1 site in United States.
Trial summary
The investigators will conduct a two-phase pilot study to test the feasibility and acceptability of a 12-week Chair Yoga intervention for 20 heart-failure patients. Using a patient-centered approach, investigators will involve stakeholders in designing the protocol, gather patient feedback, and refine the protocol… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Heart Failure, Rural Health, Engagement, Patient
- What is being tested?
- Yoga group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2025to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure diagnosis
- Aged 55 years or older
Who cannot join
- Traumatic brain injury, co-existing neurological and psychiatric disorders
- Implanted defibrillator or metal objects, left ventricular assist device placement, or cardiac transplant
- Substance abuse
- Unable to perform yoga due to physical limitations or severity of illness
- Currently engaged in a yoga program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Auburn University
Auburn, Alabama, 36849
Chin-Yen Lin, 334-844-5619, czl0194@auburn.edu
About this study
Official title: Engaging Stakeholders and Patients to Evaluate the Feasibility of Yoga to Improve Cognitive Function in Rural Heart Failure Patients in the Deep South
The investigators will conduct a two-phase pilot study to test the feasibility and acceptability of a 12-week Chair Yoga intervention for 20 heart-failure patients. Using a patient-centered approach, investigators will involve stakeholders in designing the protocol, gather patient feedback, and refine the protocol accordingly.
Read the detailed description
The aims of this study include:
Phase 1: Engaging stakeholders and patients to develop the initial study protocol.
- Engage stakeholders and patients to develop the initial study protocol.
- Recruit the first 10 patients to complete a 12-week online yoga intervention and collect data before and after the yoga intervention.
- Evaluate the feasibility of yoga intervention and revise the initial study protocol with stakeholders based on the data collected from the patients.
Phase 2: Pilot the revised protocol and finalize plans.
- Implement the revised study protocol for the next 10 patients, deliver a 12-week online yoga intervention, and collect data before and after the yoga intervention.
- Evaluate the pilot results on the feasibility of yoga intervention to enhance patient-centered outcomes and cognitive function based on the data collected from the patients.
- Finalize the study protocol with stakeholders and disseminate findings with communities.
- Conditions
- Heart Failure, Rural Health, Engagement, Patient
- Being tested
- Yoga group
- Medical subject headings
- Heart Failure, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga groupBehavioural
Chair yoga intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Chair yoga intervention Receives: Behavioral: Yoga group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions and experiences of yoga practice measured by the Essential Properties of Yoga Questionnaire.
Includes 62 items. Rated on Likert scales from 0 (not at all) to 4 (a very large amount). Score range converted to 0 to 100%, with higher scores indicating a stronger presence/intensity of the specific yoga property.
Measured: After completion of 12-week intervention.
Cognitive function measured by the Montreal Cognitive Assessment.
Score range 0 to 30. Score ≥26: generally normal (context-dependent); 18-25: mild impairment range; <18: more likely moderate-severe impairment.
Measured: Baseline
Secondary outcomes (2)
Health-related quality of life measured by the Minnesota Living with Heart Failure Questionnaire.
Response scale: 0 (no impact) to 5 (very much). Score ranges from 0 to 105, with higher scores indicating worse quality of life.
Measured: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention.
Social factors of health measured by the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences.
For each PRAPARE item, mark responses indicating unmet social need as "1" (risk) and acceptable/no-need responses as "0." Scores are calculated by summing each item; higher scores indicate more social needs.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start24 Jul 2025
- Primary completion31 Dec 2026 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Chin-Yen Lin, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489105
- Sponsor's protocol ID
- AU-25-001
- Other IDs
- 5P50MD017338-04
- Acronym
- Forge AHEAD
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 25 Mar 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Stakeholders and Patients to Evaluate the Feasibility of Yoga to Improve Cognitive Function in Rural Heart Failure Patients in the Deep South
- ClinicalTrials.gov ID
- NCT07489105
- Acronym / sponsor ID
- Forge AHEAD / AU-25-001
- Conditions
- Heart Failure, Rural Health, Engagement, Patient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Mar 2026 (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.
The investigators will conduct a two-phase pilot study to test the feasibility and acceptability of a 12-week Chair Yoga intervention for 20 heart-failure patients. Using a patient-centered approach, investigators will involve stakeholders in designing the protocol, gather patient feedback, and refine the protocol accordingly.
Detailed description
The aims of this study include:
Phase 1: Engaging stakeholders and patients to develop the initial study protocol.
- Engage stakeholders and patients to develop the initial study protocol.
- Recruit the first 10 patients to complete a 12-week online yoga intervention and collect data before and after the yoga intervention.
- Evaluate the feasibility of yoga intervention and revise the initial study protocol with stakeholders based on the data collected from the patients.
Phase 2: Pilot the revised protocol and finalize plans.
- Implement the revised study protocol for the next 10 patients, deliver a 12-week online yoga intervention, and collect data before and after the yoga intervention.
- Evaluate the pilot results on the feasibility of yoga intervention to enhance patient-centered outcomes and cognitive function based on the data collected from the patients.
- Finalize the study protocol with stakeholders and disseminate findings with communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Yoga groupChair yoga intervention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heart failure diagnosis
- Aged 55 years or older
Key exclusion criteria (5 listed)
- Traumatic brain injury, co-existing neurological and psychiatric disorders
- Implanted defibrillator or metal objects, left ventricular assist device placement, or cardiac transplant
- Substance abuse
- Unable to perform yoga due to physical limitations or severity of illness
- Currently engaged in a yoga program
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 groupChair yoga intervention | Behavioural | Intervention |
Primary outcome
Perceptions and experiences of yoga practice measured by the Essential Properties of Yoga Questionnaire.
Time frame: After completion of 12-week intervention.
Includes 62 items. Rated on Likert scales from 0 (not at all) to 4 (a very large amount). Score range converted to 0 to 100%, with higher scores indicating a stronger presence/intensity of the specific yoga property.
Cognitive function measured by the Montreal Cognitive Assessment.
Time frame: Baseline
Score range 0 to 30. Score ≥26: generally normal (context-dependent); 18-25: mild impairment range; <18: more likely moderate-severe impairment.
2 secondary outcomes
Health-related quality of life measured by the Minnesota Living with Heart Failure Questionnaire.
Time frame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention.
Social factors of health measured by the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences.
Time frame: Baseline
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 25 Mar 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.
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 group in people with Heart Failure and Rural Health, 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Mar 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. 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?
Contact Chin-Yen Lin, PhD, RN (334-844-5619, czl0194@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptions and experiences of yoga practice measured by the Essential Properties of Yoga Questionnaire. (time frame: After completion of 12-week intervention.). The study lists 2 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 25 Mar 2026.