Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-03-02 @ 4:10 AM
Study NCT ID:
NCT03920969
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2019-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sport and Self Esteem in Patients Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006679', 'term': 'HIV Seropositivity'}], '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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1169}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2019-04-16', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of self-esteem according to the sport activity of PLHIV', 'timeFrame': 'six months', 'description': 'Prevalence of self-esteem (Rosenberg questionnaire) among PLHIV, according to sport activity'}], 'secondaryOutcomes': [{'measure': 'Description of the sporting activity of an adult HIV population', 'timeFrame': 'Six months', 'description': 'Number and frequency of characteristics related to sports activity'}, {'measure': 'Description of factors associated with sports activity: fatigue', 'timeFrame': 'Six months', 'description': 'Prevalence of fatigue symptoms'}, {'measure': 'Description of factors associated with sports activity: pain', 'timeFrame': 'Six months', 'description': 'Prevalence of pain symptoms'}, {'measure': 'Description of factors associated with sports activity: sleep', 'timeFrame': 'Six months', 'description': 'Prevalence of sleep disorders'}, {'measure': 'Search for a correlation between physical activity and HIV activity', 'timeFrame': '6 months', 'description': 'Measure of the correlation between the measured physical activity and CD4 levels and HIV load.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sport', 'HIV', 'Self Esteem'], 'conditions': ['HIV Seropositivity']}, 'descriptionModule': {'briefSummary': 'Adapted athletic activity has shown benefits in patients with certain chronic diseases, including improving fatigue and pain in patients with cancer, and improving the symptoms of severe depression.\n\nAmong Patients Living with Human Immunodeficiency Virus (PLHIV), sport appears to be less common than for people who do not live with HIV. In fact, 44% of PLHIV in a Swiss cohort (10,500 patients) were inactive in 2014, whereas this percentage was 26% in the general population in Switzerland. We did not find any French data on the prevalence of sports activity among PLHIV.\n\nThe benefits of sport in PLHIV are numerous: meta-analyzes on interventional studies of aerobic and resistance exercises show a significant improvement in maximum oxygen consumption, muscle strength, percentage of body fat, quality of life and symptoms of depression. An improvement in cognitive function was noted in a randomized study. An Iranian randomized study of 2017 showed an improvement in the CD4 count, after 8 weeks of resistive exercise, but two meta-analyzes of 2016 and 2017 did not find a significant change in CD4 or viral load with physical exercise.\n\nOn the other hand, several studies have shown that sports practice improves self-esteem. In addition, an Australian randomized study in 2006 showed an improvement in self-efficacy in PLHIVs after a six-month exercise (aerobic and resistance) program. Furthermore, self-esteem (defined as positive self-esteem) is a factor facilitating adherence to antiretroviral therapy.\n\nThe objective of this descriptive study is to evaluate the prevalence of sports activity in a French adult population infected with HIV and to seek an association with self-esteem. In addition, the investigators will look for an association between sport and fatigue, pain, sleep, lymphocyte T CD4 cell levels, viral load.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of all HIV-infected patients followed in one of the COREVIH centers of Pays de la Loire participating in this study. Participation in the study will be offered to patients during a usual visit as part of the follow-up of their pathology. The annual number of patients in 2017 being 4300, it is estimated that the number of patients included will be between 1000 and 2000 over 6 months of inclusion with a response rate of at least 50%.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with HIV\n* aged over 18\n* Patient followed by a physician in one of the participating centers of the Regional coordination of the fight against HIV infection (COREVIH) Pays de la Loire\n\nExclusion Criteria:\n\n* Refusal or unability to answer the self-questionnaire.\n* Patient Under guardianship'}, 'identificationModule': {'nctId': 'NCT03920969', 'briefTitle': 'Sport and Self Esteem in Patients Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'Assessment of Self-esteem According to the Practice of a Sport Activity in a Population of Adults Living With HIV', 'orgStudyIdInfo': {'id': 'CHM-2018-S10/002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sports activity', 'type': 'BEHAVIORAL', 'description': 'Evaluation of physical activity using the International Physical Activity Questionnaire (IPAQ) short version.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72 000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Centre Hospitalier Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'overallOfficials': [{'name': 'Lucia Perez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Le Mans'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'collaborators': [{'name': 'COordination REgionale de lutte contre les IST et le VIH (COREVIH) des Pays de la Loire', 'class': 'UNKNOWN'}, {'name': 'Nantes University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, {'name': 'Hospital, La Roche sur Yon', 'class': 'UNKNOWN'}, {'name': 'Hospital, Saint Nazaire', 'class': 'UNKNOWN'}, {'name': 'Centre Hospitalier de Cholet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}