Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 1:21 AM
Study NCT ID:
NCT07489105
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Forge AHEAD: Feasibility of Yoga to Improve Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-21', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceptions and experiences of yoga practice measured by the Essential Properties of Yoga Questionnaire.', 'timeFrame': 'After completion of 12-week intervention.', 'description': '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.'}, {'measure': 'Cognitive function measured by the Montreal Cognitive Assessment.', 'timeFrame': 'Baseline', 'description': 'Score range 0 to 30. Score ≥26: generally normal (context-dependent); 18-25: mild impairment range; \\<18: more likely moderate-severe impairment.'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life measured by the Minnesota Living with Heart Failure Questionnaire.', 'timeFrame': 'Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention.', 'description': 'Response scale: 0 (no impact) to 5 (very much). Score ranges from 0 to 105, with higher scores indicating worse quality of life.'}, {'measure': "Social factors of health measured by the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences.", 'timeFrame': 'Baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Rural Health', 'Engagement, Patient']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The aims of this study include:\n\nPhase 1: Engaging stakeholders and patients to develop the initial study protocol.\n\n1. Engage stakeholders and patients to develop the initial study protocol.\n2. Recruit the first 10 patients to complete a 12-week online yoga intervention and collect data before and after the yoga intervention.\n3. Evaluate the feasibility of yoga intervention and revise the initial study protocol with stakeholders based on the data collected from the patients.\n\nPhase 2: Pilot the revised protocol and finalize plans.\n\n1. 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.\n2. 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.\n3. Finalize the study protocol with stakeholders and disseminate findings with communities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart failure diagnosis\n* Aged 55 years or older\n\nExclusion Criteria:\n\n* Traumatic brain injury, co-existing neurological and psychiatric disorders\n* Implanted defibrillator or metal objects, left ventricular assist device placement, or cardiac transplant\n* Substance abuse\n* Unable to perform yoga due to physical limitations or severity of illness\n* Currently engaged in a yoga program'}, 'identificationModule': {'nctId': 'NCT07489105', 'acronym': 'Forge AHEAD', 'briefTitle': 'Forge AHEAD: Feasibility of Yoga to Improve Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'Auburn University'}, 'officialTitle': 'Engaging Stakeholders and Patients to Evaluate the Feasibility of Yoga to Improve Cognitive Function in Rural Heart Failure Patients in the Deep South', 'orgStudyIdInfo': {'id': 'AU-25-001'}, 'secondaryIdInfos': [{'id': '5P50MD017338-04', 'link': 'https://reporter.nih.gov/quickSearch/5P50MD017338-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Chair yoga intervention', 'interventionNames': ['Behavioral: Yoga group']}], 'interventions': [{'name': 'Yoga group', 'type': 'BEHAVIORAL', 'description': 'Chair yoga intervention', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36849', 'city': 'Auburn', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chin-Yen Lin', 'role': 'CONTACT', 'email': 'czl0194@auburn.edu', 'phone': '334-844-5619'}], 'facility': 'Auburn University', 'geoPoint': {'lat': 32.60986, 'lon': -85.48078}}], 'centralContacts': [{'name': 'Chin-Yen Lin, PhD, RN', 'role': 'CONTACT', 'email': 'czl0194@auburn.edu', 'phone': '334-844-5619'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Auburn University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chin-Yen Lin', 'investigatorAffiliation': 'Auburn University'}}}}