- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03920969
Sport and Self Esteem in Patients Living With HIV
Assessment of Self-esteem According to the Practice of a Sport Activity in a Population of Adults Living With HIV
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Le Mans, France, 72 000
- Centre Hospitalier Le Mans
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of self-esteem according to the sport activity of PLHIV
Time Frame: six months
|
Prevalence of self-esteem (Rosenberg questionnaire) among PLHIV, according to sport activity
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description of the sporting activity of an adult HIV population
Time Frame: Six months
|
Number and frequency of characteristics related to sports activity
|
Six months
|
|
Description of factors associated with sports activity: fatigue
Time Frame: Six months
|
Prevalence of fatigue symptoms
|
Six months
|
|
Description of factors associated with sports activity: pain
Time Frame: Six months
|
Prevalence of pain symptoms
|
Six months
|
|
Description of factors associated with sports activity: sleep
Time Frame: Six months
|
Prevalence of sleep disorders
|
Six months
|
|
Search for a correlation between physical activity and HIV activity
Time Frame: 6 months
|
Measure of the correlation between the measured physical activity and CD4 levels and HIV load.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lucia Perez, MD, CH Le mans
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHM-2018-S10/002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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