Clinical Trials

MainTitle

Sport and Self Esteem in Patients Living With HIV

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2019 by Centre Hospitalier le Mans

Sponsor
Centre Hospitalier le Mans

Collaborator
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
ClinicalTrials.gov Identifier
NCT03920969

First received: April 16, 2019
Last updated: August 20, 2019
Last Verified: May 2019
History of Changes
Purpose

Purpose

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 Intervention
HIV Seropositivity

Behavioral : Sports activity

Study Type: Observational
Study Design: 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

Further study details as provided by Centre Hospitalier le Mans:

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
Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 2000
Study Start Date: February 1, 2019
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: November 30, 2019 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03920969

Contacts

Contact:   Christelle Jadeau, PD 0 (33) 2 43 43 43 43 ext 37482 cjadeau@ch-lemans.fr

Locations

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

Principal Investigator: Lucia Perez, MD CH Le Mans
More Information

More Information


Responsible Party: Centre Hospitalier le Mans  
ClinicalTrials.gov Identifier: NCT03920969   History of Changes  
Other Study ID Numbers: CHM-2018-S10/002  
Study First Received: April 16, 2019  
Last Updated: August 20, 2019  
Individual Participant Data    
Plan to Share IPD: Undecided  

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:
HIV Seropositivity

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.