Clinical trial NCT03920969: Sport and Self Esteem in Patients Living With HIV
Official title: Assessment of Self-esteem According to the Practice of a Sport Activity in a Population of Adults Living With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Seropositivity
Keywords: Sport
HIV
Self Esteem
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
Collaborators: name: COordination REgionale de lutte contre les IST et le VIH (COREVIH) des Pays de la Loire
name: Nantes University Hospital
name: University Hospital, Angers
name: Hospital, La Roche sur Yon
name: Hospital, Saint Nazaire
name: Centre Hospitalier de Cholet
First posted: 2019-04-19
Enrollment: 1169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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%.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of self-esteem according to the sport activity of PLHIV
timeFrame: six months
Secondary outcomes:
measure: Description of the sporting activity of an adult HIV population
timeFrame: Six months
measure: Description of factors associated with sports activity: fatigue
timeFrame: Six months
measure: Description of factors associated with sports activity: pain
timeFrame: Six months
measure: Description of factors associated with sports activity: sleep
timeFrame: Six months
measure: Search for a correlation between physical activity and HIV activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
Study officials:
affiliation: CH Le Mans
name: Lucia Perez, MD
role: PRINCIPAL_INVESTIGATOR
References: