Implementation and Effectiveness of Physical Activity to Prevent Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire

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 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.

Conditions

• HIV Infections
• Cardiovascular Diseases
• Insulin Resistance Syndrome X

Interventions

BEHAVIORAL

Physical activity programme

48-week exercise programme including aerobic, resistance, balance and flexibility exercises twice to three times per week. The sessions are supervised by a coach at least once a week during the first 6 months then monthly. The other session of the PA programme is performed at home and the overall weekly PA is reviewed with the coach at the end of the supervised session.

BEHAVIORAL

Home-based physical activity

48-week exercise programme including aerobic, resistance, balance and flexibility exercises twice to three times per week. Participants have to perform the exercise programme at home exclusively. They are called every week by a research assistant to review the activities performed, collect information on their adherence and perception on the programme.

Sponsors & Collaborators

• Institut de Recherche pour le Développement (IRD)

  collaborator UNKNOWN

• Programme PAC-CI

  collaborator UNKNOWN

• Université Paris Cité

  collaborator OTHER

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Principal Investigators

• Pierre Debeaudrap · IRD

• Patrick Coffie · PAC-CI

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-31

Primary Completion

2026-10-31

Completion

2027-05-31

Countries

• Côte d’Ivoire

Study Locations