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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03920969
Other study ID # CHM-2018-S10/002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date December 31, 2019

Study information

Verified date March 2022
Source Centre Hospitalier le Mans
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. Among 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. The 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. On 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. The 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.


Recruitment information / eligibility

Status Completed
Enrollment 1169
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient with HIV - aged over 18 - 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 Exclusion Criteria: - Refusal or unability to answer the self-questionnaire. - Patient Under guardianship

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sports activity
Evaluation of physical activity using the International Physical Activity Questionnaire (IPAQ) short version.

Locations

Country Name City State
France Centre Hospitalier Le Mans Le Mans

Sponsors (7)

Lead Sponsor Collaborator
Centre Hospitalier le Mans Centre Hospitalier de Cholet, COordination REgionale de lutte contre les IST et le VIH (COREVIH) des Pays de la Loire, Hospital, La Roche sur Yon, Hospital, Saint Nazaire, Nantes University Hospital, University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of self-esteem according to the sport activity of PLHIV Prevalence of self-esteem (Rosenberg questionnaire) among PLHIV, according to sport activity six months
Secondary Description of the sporting activity of an adult HIV population Number and frequency of characteristics related to sports activity Six months
Secondary Description of factors associated with sports activity: fatigue Prevalence of fatigue symptoms Six months
Secondary Description of factors associated with sports activity: pain Prevalence of pain symptoms Six months
Secondary Description of factors associated with sports activity: sleep Prevalence of sleep disorders Six months
Secondary Search for a correlation between physical activity and HIV activity Measure of the correlation between the measured physical activity and CD4 levels and HIV load. 6 months
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