NCT03920969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,169

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

April 16, 2019

Last Update Submit

March 8, 2022

Conditions

Keywords

SportHIVSelf Esteem

Outcome Measures

Primary Outcomes (1)

  • Assessment of self-esteem according to the sport activity of PLHIV

    Prevalence of self-esteem (Rosenberg questionnaire) among PLHIV, according to sport activity

    six months

Secondary Outcomes (5)

  • Description of the sporting activity of an adult HIV population

    Six months

  • Description of factors associated with sports activity: fatigue

    Six months

  • Description of factors associated with sports activity: pain

    Six months

  • Description of factors associated with sports activity: sleep

    Six months

  • Search for a correlation between physical activity and HIV activity

    6 months

Interventions

Sports activityBEHAVIORAL

Evaluation of physical activity using the International Physical Activity Questionnaire (IPAQ) short version.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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%.

You may qualify if:

  • 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

You may not qualify if:

  • Refusal or unability to answer the self-questionnaire.
  • Patient Under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Mans

Le Mans, 72 000, France

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Lucia Perez, MD

    CH Le Mans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 19, 2019

Study Start

February 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations