Forge AHEAD: Feasibility of Yoga to Improve Cognitive Function (Forge AHEAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Engagement, Patient; Rural Health
• Intervention / Treatment: Behavioral: Yoga group

Detailed Description

The aims of this study include:

Phase 1: Engaging stakeholders and patients to develop the initial study protocol.

1. Engage stakeholders and patients to develop the initial study protocol.
2. Recruit the first 10 patients to complete a 12-week online yoga intervention and collect data before and after the yoga intervention.
3. 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.

1. 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.
2. 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.
3. Finalize the study protocol with stakeholders and disseminate findings with communities.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chin-Yen Lin, PhD, RN; Phone Number: 334-844-5619; Email: czl0194@auburn.edu

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Recruiting
      • Auburn University
      • Contact: Chin-Yen Lin; Phone Number: 334-844-5619; Email: czl0194@auburn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Heart failure diagnosis
• Aged 55 years or older

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Chair yoga intervention	Behavioral: Yoga group; Chair yoga intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Auburn University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Heart Failure; Patient Participation
• Other Study ID Numbers: AU-25-001; 5P50MD017338-04 (U.S. NIH Grant/Contract)

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