Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sport and Self Esteem in Patients Living With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03920969
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
COordination REgionale de lutte contre les IST et le VIH (COREVIH) des Pays de la Loire
Nantes University Hospital
University Hospital, Angers
Hospital, La Roche sur Yon
Hospital, Saint Nazaire
Centre Hospitalier Cholet
Information provided by (Responsible Party):
Centre Hospitalier le Mans

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 our 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, we 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

Layout table for study information
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 : July 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Description of the sporting activity of an adult HIV population [ Time Frame: Six months ]
    Number and frequency of characteristics related to sports activity

  2. Description of factors associated with sports activity: fatigue [ Time Frame: Six months ]
    Prevalence of fatigue symptoms

  3. Description of factors associated with sports activity: pain [ Time Frame: Six months ]
    Prevalence of pain symptoms

  4. Description of factors associated with sports activity: sleep [ Time Frame: Six months ]
    Prevalence of sleep disorders

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920969


Contacts
Layout table for location contacts
Contact: Christelle Jadeau, PD 0 (33) 2 43 43 43 43 ext 37482 cjadeau@ch-lemans.fr

Locations
Layout table for location information
France
Centre Hospitalier Le Mans Recruiting
Le Mans, France, 72 000
Contact: Christelle Jadeau, PD    0 (33) 2 43 43 43 43 ext 37 482    cjadeau@ch-lemans.fr   
Contact: Jean-Christophe Callahan, MD    0 (33) 2 43 43 43 43 ext 37 520    jccallahan@ch-lemans.fr   
Sponsors and Collaborators
Centre Hospitalier le Mans
COordination REgionale de lutte contre les IST et le VIH (COREVIH) des Pays de la Loire
Nantes University Hospital
University Hospital, Angers
Hospital, La Roche sur Yon
Hospital, Saint Nazaire
Centre Hospitalier Cholet
Investigators
Layout table for investigator information
Principal Investigator: Lucia Perez, MD CH Le Mans

Layout table for additonal information
Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT03920969     History of Changes
Other Study ID Numbers: CHM-2018-S10/002
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier le Mans:
Sport
HIV
Self Esteem

Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases