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Sport and Self Esteem in Patients 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.
| Condition or disease | Intervention/treatment |
|---|---|
| HIV Seropositivity | Behavioral: Sports activity |
| Study Type : | Observational |
| Estimated Enrollment : | 2000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Assessment of Self-esteem According to the Practice of a Sport Activity in a Population of Adults Living With HIV |
| Actual Study Start Date : | February 1, 2019 |
| Estimated Primary Completion Date : | November 30, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
- 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
- Description of the sporting activity of an adult HIV population [ Time Frame: Six months ]Number and frequency of characteristics related to sports activity
- Description of factors associated with sports activity: fatigue [ Time Frame: Six months ]Prevalence of fatigue symptoms
- Description of factors associated with sports activity: pain [ Time Frame: Six months ]Prevalence of pain symptoms
- Description of factors associated with sports activity: sleep [ Time Frame: Six months ]Prevalence of sleep disorders
- 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.
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 16, 2019 | ||||
| First Posted Date | April 19, 2019 | ||||
| Last Update Posted Date | August 21, 2019 | ||||
| Actual Study Start Date | February 1, 2019 | ||||
| Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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%. | ||||
| Condition | HIV Seropositivity | ||||
| Intervention | Behavioral: Sports activity
Evaluation of physical activity using the International Physical Activity Questionnaire (IPAQ) short version.
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
2000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2019 | ||||
| Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03920969 | ||||
| Other Study ID Numbers | CHM-2018-S10/002 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Centre Hospitalier le Mans | ||||
| Study Sponsor | Centre Hospitalier le Mans | ||||
| Collaborators |
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| Investigators |
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| PRS Account | Centre Hospitalier le Mans | ||||
| Verification Date | May 2019 | ||||
