Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT05965518
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to high-intensity interval training or continuous moderate exercise for 12 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participant Safety, Adherence to the Intervention, Retention', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Participant safety will be assessed based on the number of adverse events which leads to termination of the exercise training. This will be registered as a binary outcome (yes/no). Adherence to the intervention will be measured based on the percentage of the exercise sessions that the participants attend. Retention at assessments will be measured by trial condition for each primary outcome assessment (e.g., immediately post-intervention and 3-months post-intervention). Participants will be considered retained if they complete the assessment visit in its entirety. It will be expressed as a percentage of participants with available outcome assessments immediately post-intervention and 3-months post-intervention).'}], 'primaryOutcomes': [{'measure': 'Change in vascular function', 'timeFrame': 'Baseline, Up to 16 weeks, 3-months Post-Intervention', 'description': 'Arterial stiffness is a continuous measure of cardiovascular disease risk.'}, {'measure': 'Change in cognitive function', 'timeFrame': 'Baseline, Up to 16 weeks, 3-months Post-Intervention', 'description': 'Cognitive function will be measured using BRACE+, a neuropsychological battery'}], 'secondaryOutcomes': [{'measure': 'Barriers to Engagement in Exercise', 'timeFrame': 'Baseline', 'description': 'This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.'}, {'measure': 'Perceptions of the Study and Exercise Interventions', 'timeFrame': 'Up to 16 weeks', 'description': 'This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV', 'Arterial Stiffness', 'Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '41026763', 'type': 'DERIVED', 'citation': 'Jones R, Hankes MJ, Vickers JK, Kulik GL, Jankowski CM, Oliveira V, Khuu V, Cook PF, Li P, Vance DE, Ivankova NV, Erlandson KM, Webel AR, Buford TW, Fazeli PL. Examining High-Intensity Exercise on Cognitive and Vascular Outcomes in Older Adults Living With HIV-A Research Protocol: Design and Rationale From Two Harmonized Clinical Studies in the Deep South. J Assoc Nurses AIDS Care. 2025 Oct 1:10.1097/JNC.0000000000000591. doi: 10.1097/JNC.0000000000000591. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "This is a single site, randomized exercise trial with individuals at least 50 years of age living with HIV who experience suboptimal cognition. The overall goals of this proposal are to determine whether 16 weeks of structured high-intensity interval training (HIIT) can overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous moderate exercise. Additionally, investigator will seek to identify barriers to engagement in exercise and the participants' perceptions of the study and exercise interventions (Aim 2). This study will enroll 60 participants in Birmingham, Alabama. Data collection will occur at each visit, with baseline data collected at the initial visit with a 3-month follow-up occurring following completion of the intervention.", 'detailedDescription': "This is a single site, randomized exercise trial with individuals at least 50 years of age living with HIV who experience suboptimal cognition. The overall goals of this proposal are to determine whether 12 weeks of structured high-intensity interval training (HIIT) can overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous moderate exercise. Additionally, investigator will seek to identify barriers to engagement in exercise and the participants' perceptions of the study and exercise interventions (Aim 2). This study will enroll 60 participants in Birmingham, Alabama.\n\nVascular function will be measured using pulse wave velocity. Cognition will be assessed using the full neuropsychological battery. Additionally, perceptions of exercise and the study as well as barriers to engaging in exercise will be determined through the analysis qualitative interviews.\n\nThe overall hypothesis is that HIIT will result in greater enhancements in vascular and cognitive function. The investigators expect that individuals randomized to HIIT will result in greater satisfaction with the protocol. Based on the data collected, the investigators seek to develop tailored intervention to promote successful aging among older people living with HIV."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 years and older\n* Sedentary lifestyle, defined as \\< 150 min/wk moderate physical activity as assessed by CHAMPS questionnaire\n* Neurocognitive Impairment (as assessed using the BRACE+\n* Prescribed HIV ART for ≥ 12 months, with no current use of older drugs with established mitochondrial toxicity\n* Able to speak, read, and write in English\n* Willingness to participate in all study procedures\n\nExclusion Criteria:\n\n* Diagnosis of mitochondrial disease\n* Active substance abuse or factors preventing compliance or safety\n* Uncontrolled hypertension, defined as resting BP \\> 150/90 mmHG\n* Chronic kidney disease\n* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina\n* Acute myocardial infarction identified by medical history and ECG\n* Pulmonary disease requiring the use of supplemental oxygen\n* Poorly controlled diabetes\n* Neuropsychologically Intact\n* Orthopedic problems that limit ability to perform exercise\n* Simultaneous participation in another intervention trial'}, 'identificationModule': {'nctId': 'NCT05965518', 'briefTitle': 'High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Pilot Trial of High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Older Adults With HIV', 'orgStudyIdInfo': {'id': 'IRB-300011502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Intensity Interval Training', 'interventionNames': ['Behavioral: High-Intensity Interval Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Moderate Exercise', 'interventionNames': ['Behavioral: Continuous Moderate Exercise']}], 'interventions': [{'name': 'High-Intensity Interval Training', 'type': 'BEHAVIORAL', 'description': 'Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.', 'armGroupLabels': ['High-Intensity Interval Training']}, {'name': 'Continuous Moderate Exercise', 'type': 'BEHAVIORAL', 'description': 'Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak, followed by a 4 minute cool-down. The total exercise time is 50 minutes.', 'armGroupLabels': ['Continuous Moderate Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raymond Jones, Ph.D.', 'role': 'CONTACT', 'email': 'raymondjones@uabmc.edu', 'phone': '205-996-3569'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Raymond Jones, Ph.D.', 'role': 'CONTACT', 'email': 'raymondjones@uabmc.edu', 'phone': '205-996-3569'}], 'overallOfficials': [{'name': 'Raymond Jones, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be made available no later than the time of an associated publication or end of the funding period, whichever comes first. NACDA guarantees data will be made available for ≥10 years', 'ipdSharing': 'YES', 'description': 'Participant-level deidentified data will be preserved through deposition of the data in a controlled public repository. All aggregate datasets that can be shared publicly will be deposited in the NIH/NIA Repository, National Archive of Computerized Data on Aging (NACDA).', 'accessCriteria': 'De-identified individual participant data will be deposited into NACDA as restricted, which limits access to the data to qualified investigators with who must sign a data use agreement. NACDA requires users to submit a data use agreement. NACDA will review the data request for completeness and determine if an IRB approval is needed. Anyone who has submitted an approved data request and signed data use agreement on NACDA will be given access to the data without cost, for a set period.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Raymond Jones', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}