ACTIVE NOT RECRUITING
NCT06139497
Implementation and Effectiveness of Physical Activity to Prevent Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire
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.
Gender: All
Ages: 50 Years - Any
HIV Infections
Cardiovascular Diseases
Insulin Resistance Syndrome X