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| Name | Class |
|---|---|
| Institut de Recherche pour le Développement (IRD) | UNKNOWN |
| Programme PAC-CI | UNKNOWN |
| Université Paris Cité | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groupes-based arm | Experimental | 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). |
|
| Home-based arm | Experimental | Participants have to perform the same exercise programme at home. Start with two weeks of direct supervision to learn how to carry out safely the training and how to adapt the intensity of the exercise using the rated perceived exertion (RPE) and the heart rate self-monitored during exercise. |
|
| Control arm | No Intervention | Health education session every months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity programme | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance at the 6 minute step-up test | Number of ascent-descent cycles counted over 6 minutes | Baseline, Month 6 and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Performance at the 6 minute walking test | Distance covered during a 6-minute period of rapid walking on a flat and hard surface | Baseline and Month 12 |
| Performances at the 6 minute stand up test |
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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:
Signed informed consent.
Exclusion criteria
Eligibility criteria for the formative research:
Inclusion criteria:
People living with HIV:
Controls:
Exclusion Criteria:
Participants living with HIV:
Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Debeaudrap | IRD | Principal Investigator |
| Patrick Coffie | PAC-CI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Médical Spécialisé El Rapha | Abidjan | Côte d’Ivoire | ||||
| Formation semi urbaine (FSU) d'Abobo Avocatier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41494181 | Derived | Diadhiou N, Assoumou N, Tegbe J, Boa HE, Bao ML, Amador-Paz S, Vitiello D, Coffie P, Debeaudrap P. Effectiveness and Implementation of Adapted Physical Activity Delivery Strategies for Older Adults Living With HIV in Ivory Coast: Protocol for a Type 2 Hybrid Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 6;15:e84677. doi: 10.2196/84677. |
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Hybrid type 2 (dual focus on effectiveness and implementation outcomes)
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|
| Home-based physical activity | Behavioral | 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. |
|
Number of stand up - sit movements performed during a 6 minute period
| Baseline, Month 6 |
| Performances at the Y balance Test | 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 | Baseline |
| Grip strength | Force in kg measured with a dynamometer, twice per limb | Baseline, Month 6 and Month 12 |
| WHO Disability Assessment Schedule - 2.0 (WHODAS) score | Score ranging between 0 and 100. Higher score indicates higher levels of difficulties for functioning | Baseline and Month 12 |
| HIV Disability Questionnaire - short form (HDQ-SF) score | The higher the calculated score, the more significant the encountered difficulties | Day 0 |
| Short Physical Performance Battery (SPPB) score | Score between 0 and 12, with 0 indicating the worst performance and 12 the highest degree of functionality | Baseline and Month 12 |
| Scores of the Neuroscreen app tests | Scores calculated by the application overall and for different cognitive domains: that higher scores indicated better performance. | Baseline and Month 12 |
| Fasting blood glucose | Measured on capillary blood | Baseline and Month 12 |
| IDIR test | Measure of urinary branched chain amino acid (BCCA) to detect insulin resistance | Baseline, Month 6 and Month 12 |
| WHO-QoL | Quality of life brief questionnaire (WHO). It includes 26 items measured on 5 point scales. | Baseline, Month 6 and Month 12 |
| PHQ-9 | Short questionnaire on depression. Score ranging from 0 to 27. Higher score indicates depressive symptoms | Baseline, Month 6 and Month 12 |
| Satisfaction and acceptability of physical activity | Questionnaire based on Sekhon's framework. Use 5-point Likert scales | Week 12, Month 6 and Month 12 |
| Abidjan |
| Côte d’Ivoire |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D002318 | Cardiovascular Diseases |
| D024821 | Metabolic Syndrome |
| D009043 | Motor Activity |
| D000073296 | Noncommunicable Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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