NCT06139497Active, not recruiting
Implementation and Effectiveness of Physical Activity to Prevent Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire
Feasibility and Effectiveness of a Pilot Program of Physical Activity to Improve Functional Limitations and Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
The overall objective of this research is to provide evidence on the effectiveness and implementation of two strategies deliver a structured programme of physical activity (PA) people living with HIV older than 50 years from Ivory Coast. The research will starts a baseline formative research including people with and without HIV infection. Participants are randomized 1:1:1 to one for the following group: (1) a reference arm receiving a group-based PA program supervised by a coach (n = 60), (2) an exploratory arm receiving a home-based PA program with remote supervision via phone calls and messaging apps (n = 60) and (3) a control arm receiving health education sessions (n = 60). The total follow-up period is 12 months, with an initial 6-month active phase and then a 6-month maintenance. The primary effectiveness outcome is the improvement at the 6-minute step-up test between baseline and 6 months. Secondary outcomes include changes in performance on other functional tests and improvement of cardio-metabolic risk factors. Implementation outcomes include acceptability, adoption, feasibility and sustainability of the intervention.Implementation outcomes will be assessed using mixed methods during the intervention. Effectiveness outcomes and patient-centered outcomes will be assessed at baseline, 6 and 12 months.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 180 (actual)
- First submitted
- 2 Nov 2023
- Start date
- 31 Oct 2023
- Primary completion date
- Oct 2026
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- HIV
- NCT number
- NCT06139497
What you commit to
- Study type: Interventional
- Participants enrolled: 180
- From 31 Oct 2023 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Another health condition requiring priority care.
- Eligibility criteria for the formative research:
- Participants living with HIV:
- HIV infection with HIV-2 type only
- Any clinical symptoms suggesting an acute infection
- Any clinical symptoms suggesting an acute infection
Other
- Medical contraindication to physical activity.
- Anticipated unavailability.
- Severe functional limitation (SPPB ≤ 3).
- Any life-threatening pathology in the short term or any pathology not allowing participation in the study
- Controls:
- Any life-threatening pathology in the short term or any pathology not allowing participation in the study
Who the study is looking for
- Age ≥50 years
- Documented HIV infection.
- Receiving antiretroviral therapy for ≥ 12 months.
- Residing in the Abobo district (Côte d'Ivoire).
- Presence of at least one functional limitation or disability criterion among the following:
- Performance in the 6-minute walk test ≤ 300 m.
- Handgrip strength ≤ 35 kg for men or ≤ 24 kg for women.
- WHODAS score ≥ 10.
- SPPB score between 4 and 9.
- Signed informed consent.
- People living with HIV:
- Age ≥40 years
- Documented HIV infection.
- Receiving antiretroviral therapy for ≥ 12 months.
- Controls:
- Age ≥40 years
- Negative HIV test within the last 12 months;
- Living in Abobo area
- Written consent to participate to the study
Criteria the registry did not label
- Eligibility criteria for the intervention :
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Médical Spécialisé El Rapha Coordinator of this site? Confirm its status | Abidjan | Côte d’Ivoire | Unknown status |
| Formation semi urbaine (FSU) d'Abobo Avocatier Coordinator of this site? Confirm its status | Abidjan | Côte d’Ivoire | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.