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

Not Applicable

Active, not recruiting

• Conditions: HIV Infections; Cardiovascular Diseases; Insulin Resistance Syndrome X

• Registration Number: NCT06139497
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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 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.

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 intervention's effects. This study adopts a type II hybrid design assessing both the effectiveness of the intervention and the implementation outcomes to identify factors influencing its adoption by users, as well as its integration into healthcare practices

It starts with a baseline research combining a cross-sectional study and a qualitative formative research. The cross-sectional study comprises clinical evaluations, functional tests, as well as quantitative evaluations by questionnaire of disability (WHODAS, HDQ) and depression (PHQ-9). It includes 300 people living wiht HIV (PLHIV) receiving antiretroviral therapy and followed at the Avocatier health facility (FSU) and the El Rapha medical health centre (CMS), in the Abobo district, Abidjan. A comparison group of adults without HIV infection of similar sex and age distribution is included as a reference group (n = 150).

The qualitative research explores how the practice of physical activity is perceived culturally and socially and to determine the factors that may influence the implementation of this type of activity.

The intervention consists of a 48-week exercise programme including aerobic, resistance, balance and flexibility exercises twice to three times a week for at least 60 minutes. Two delivery approaches for the exercise programme are proposed. In the group-based arm, participants are invited to participate in group sessions directly supervised by a coach. The other sessions are unsupervised. During the first 24 weeks (active phase), the supervised group sessions are scheduled on a weekly basis while they are more spaced out, on a monthly basis, during the second part of the 48 weeks (maintenance phase). In the home-based arm, participants have to perform the same exercise programme at home. Participants are contacted by phone by a study staff every week to review the activities performed, collect information on their adherence to and perception of the programme and to provide positive feedback, help to addess challenges and reinforce their motivation. Participants of the control group are offered monthly health education sessions and a delayed participation to the programme.

Study Timeline

• Study Start: 2023-10-31
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-10
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Performance at the 6 minute step-up test	Baseline, Month 6 and Month 12	Number of ascent-descent cycles counted over 6 minutes

Secondary Outcome Measures

Name	Time	Method
Performance at the 6 minute walking test	Baseline and Month 12	Distance covered during a 6-minute period of rapid walking on a flat and hard surface
Performances at the 6 minute stand up test	Baseline, Month 6	Number of stand up - sit movements performed during a 6 minute period
Performances at the Y balance Test	Baseline	Sum of distances reached in each direction (the best is chosen for each direction) divided by 3 x length of lower limb (standardization) and multiplied by 100
Grip strength	Baseline, Month 6 and Month 12	Force in kg measured with a dynamometer, twice per limb
WHO Disability Assessment Schedule - 2.0 (WHODAS) score	Baseline and Month 12	Score ranging between 0 and 100. Higher score indicates higher levels of difficulties for functioning
HIV Disability Questionnaire - short form (HDQ-SF) score	Day 0	The higher the calculated score, the more significant the encountered difficulties
Short Physical Performance Battery (SPPB) score	Baseline and Month 12	Score between 0 and 12, with 0 indicating the worst performance and 12 the highest degree of functionality
Scores of the Neuroscreen app tests	Baseline and Month 12	Scores calculated by the application overall and for different cognitive domains: that higher scores indicated better performance.
Fasting blood glucose	Baseline and Month 12	Measured on capillary blood
IDIR test	Baseline, Month 6 and Month 12	Measure of urinary branched chain amino acid (BCCA) to detect insulin resistance
WHO-QoL	Baseline, Month 6 and Month 12	Quality of life brief questionnaire (WHO). It includes 26 items measured on 5 point scales.
PHQ-9	Baseline, Month 6 and Month 12	Short questionnaire on depression. Score ranging from 0 to 27. Higher score indicates depressive symptoms
Satisfaction and acceptability of physical activity	Week 12, Month 6 and Month 12	Questionnaire based on Sekhon's framework. Use 5-point Likert scales

Trial Locations

Locations (2)

Centre Médical Spécialisé El Rapha; Abidjan, Côte d’Ivoire

Formation semi urbaine (FSU) d'Abobo Avocatier; Abidjan, Côte d’Ivoire