Status:
ACTIVE_NOT_RECRUITING
Implementation and Effectiveness of Physical Activity to Prevent Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Institut de Recherche pour le Développement (IRD)
Programme PAC-CI
Conditions:
HIV Infections
Cardiovascular Diseases
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This is is a prospective, randomised, pilot trial with two phases: a 6-month active phase to implement the intervention and a 6-month maintenance phase to evaluate the sustainability of the interventi...
Eligibility Criteria
Inclusion
- Eligibility criteria for the intervention :
- Inclusion criteria:
- 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.
- Exclusion criteria
- Medical contraindication to physical activity.
- Anticipated unavailability.
- Severe functional limitation (SPPB ≤ 3).
- Another health condition requiring priority care.
- Eligibility criteria for the formative research:
- Inclusion criteria:
- 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
- Exclusion Criteria:
- Participants living with HIV:
- HIV infection with HIV-2 type only
- Any clinical symptoms suggesting an acute infection
- Any life-threatening pathology in the short term or any pathology not allowing participation in the study
- Controls:
- Any clinical symptoms suggesting an acute infection
- Any life-threatening pathology in the short term or any pathology not allowing participation in the study
Exclusion
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06139497
Start Date
October 31 2023
End Date
May 1 2027
Last Update
September 22 2025
Active Locations (2)
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1
Centre Médical Spécialisé El Rapha
Abidjan, Côte d’Ivoire
2
Formation semi urbaine (FSU) d'Abobo Avocatier
Abidjan, Côte d’Ivoire