Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-28 @ 4:13 AM
Study NCT ID:
NCT04321603
Status:
WITHDRAWN
Last Update Posted:
2021-08-11
First Post:
2020-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This within-subjects design will allow each subject to be utilized as their own control pre-intervention. With expectation of great inter-person variability of oxygen consumption results, this design will incorporate less error than separately recruited controls and decrease the needed sample size.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'COVID-19 prevented us from doing this human subjects study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frailty Related Phenotype', 'timeFrame': 'Day 0, Week 6, Week 12 with intervention between weeks 6 and 12', 'description': 'Change in frailty phenotype score (0-5 with 3 to 5 indicating frailty) after a six-week walking intervention'}], 'primaryOutcomes': [{'measure': 'Mitochondrial Respiration PBMC and platelets', 'timeFrame': 'Day 0, Week 6, Week 12 with intervention between weeks 6 and 12', 'description': 'Change in mitochondrial respiratory capacity after a six-week walking intervention'}], 'secondaryOutcomes': [{'measure': 'Inflammation IL-1β', 'timeFrame': 'Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months', 'description': 'Change in IL-1β after a six-week walking intervention'}, {'measure': 'Inflammation IL-6', 'timeFrame': 'Day 0, Week 6, Week 12 with intervention between weeks 6 and 12', 'description': 'Change in IL-6 after a six-week walking intervention'}, {'measure': 'Inflammation IL-10', 'timeFrame': 'Day 0, Week 6, Week 12 with intervention between weeks 6 and 12', 'description': 'Change in IL-10 after a six-week walking intervention'}, {'measure': 'Inflammation TNF-α', 'timeFrame': 'Day 0, Week 6, Week 12 with intervention between weeks 6 and 12', 'description': 'Change in TNF-α after a six-week walking intervention'}, {'measure': 'Inflammation hsCRP', 'timeFrame': 'Day 0, Week 6, Week 12 with intervention between weeks 6 and 12', 'description': 'Change in hsCRP after a six-week walking intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'mitochondrial respiration', 'inflammation'], 'conditions': ['Hiv', 'Frailty Syndrome']}, 'descriptionModule': {'briefSummary': 'People living with HIV are living longer as their disease is controlled with antiretroviral medications. Yet they are experiencing frailty more often and more than ten years earlier than those without HIV. In elderly persons without HIV, frailty is associated with decreased muscle strength and chronic inflammation. Less is known about what is driving early frailty in HIV or effective prevention measures for aging adults with HIV.\n\nIt may be that having HIV infection impairs energy production by mitochondria within the cells and contributes to the muscle weakness and inflammation accompanying frailty in people living with HIV . This study will examine the impact of six weeks of moderately paced walking on energy production in the cells, inflammation markers and frailty scores in people living with well-controlled HIV who are aged 50 to 65.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 50 to 65\n* Documentation of HIV infection from Medical Provider\n* Currently receiving antiretrovirals\n* HIV viral load less than 50 iu/mL for at least six months\n* CD4 count at least 350 cell/mm3 for the last six months\n* Willing and able to walk at least 30 minutes 3 times weekly within 30 minutes of UMB\n* Speaks English\n\nExclusion Criteria:\n\n* Current smokers\n* Weight less than 110 pounds\n* Subjects taking long-term corticosteroids equivalent to 10mg/day or more, or immunomodulators\n* Subjects with conditions known to affect inflammatory or mitochondrial function other than HIV, such as rheumatoid arthritis, gout, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, Parkinson's disease, Alzheimer's disease, active hepatitis, sleep apnea or autoimmune diseases.\n* Current drug or alcohol use or dependence or unstable mental health conditions that, in the opinion of the investigator, would interfere with adherence to study requirements"}, 'identificationModule': {'nctId': 'NCT04321603', 'acronym': 'ALTER', 'briefTitle': 'Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65', 'orgStudyIdInfo': {'id': 'HP-00089501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'People living with HIV', 'description': 'Subjects will act as own control between Visit one and Visit two, then will complete six weeks of walking, 30 minutes per walk, three times weekly between Visit Two and Visit Three.', 'interventionNames': ['Behavioral: Walking']}], 'interventions': [{'name': 'Walking', 'type': 'BEHAVIORAL', 'otherNames': ['physical activity'], 'description': 'Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.', 'armGroupLabels': ['People living with HIV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jennifer Klinedinst, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jennifer Klinedinst', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}