Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-29 @ 5:43 PM
Study NCT ID:
NCT06434168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Yoga on Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain structure', 'timeFrame': 'Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention', 'description': 'Using structural magnetic resonance imaging to examine brain structure between intervention and control groups. Less brain alteration is optimal.'}, {'measure': 'Brain functional connectivity', 'timeFrame': 'Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention', 'description': '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.'}, {'measure': 'Cognitive function', 'timeFrame': 'Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention', 'description': 'Using cognitive tests to examine cognitive function and performance between intervention and control groups. A higher score on cognitive tests indicates better cognitive function.'}, {'measure': 'Serum brain-derived neurotrophic factor', 'timeFrame': 'Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Yoga intervention', 'cognitive function'], 'conditions': ['Heart Failure', 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 55 years and older\n* Confirmed heart failure diagnosis with mild cognitive impairment\n* New York Heart Association functional class II-IV\n\nExclusion Criteria:\n\n* Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses\n* Have implanted defibrillator, left ventricular assist device placement or cardiac transplant\n* Have any other implanted metals that interfere with the MRI magnetic field for patient safety\n* Substance abuse\n* Pregnant\n* Unable to perform yoga due to physical limitations or severity of illness'}, 'identificationModule': {'nctId': 'NCT06434168', 'briefTitle': 'Impact of Yoga on Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'Auburn University'}, 'officialTitle': 'A Pilot and Feasibility Study of a Yoga Intervention in Heart Failure Patients With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'AU-24-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga intervention', 'interventionNames': ['Behavioral: Yoga intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control condition', 'interventionNames': ['Behavioral: Control condition']}], 'interventions': [{'name': 'Yoga intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Yoga intervention']}, {'name': 'Control condition', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Control condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36849', 'city': 'Auburn', 'state': 'Alabama', 'country': 'United States', 'contacts': [{'name': 'Chin-Yen Lin, RN, PhD', '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, RN, PhD', 'role': 'CONTACT', 'email': 'czl0194@auburn.edu', 'phone': '334-844-5619'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Auburn University', 'class': 'OTHER'}, 'collaborators': [{'name': 'VCOM, Auburn campus', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chin-Yen Lin', 'investigatorAffiliation': 'Auburn University'}}}}