Cardiovascular Diseases, HIV Infections, Insulin Resistance Syndrome X
Conditions
Keywords
HIV, Disabilities, Aging, Readaptation, Resource-limited countries, Physical activity, non-communicable disease
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.
Interventions
BEHAVIORALPhysical 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.
BEHAVIORALHome-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
Institut de Recherche pour le Développement (IRD)
Programme PAC-CI
Université Paris Cité
ANRS, Emerging Infectious Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Hybrid type 2 (dual focus on effectiveness and implementation outcomes)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance at the 6 minute step-up test | Baseline, Month 6 and Month 12 | Number of ascent-descent cycles counted over 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| WHO-QoL | Baseline, Month 6 and Month 12 | Quality of life brief questionnaire (WHO). It includes 26 items measured on 5 point scales. |
| 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 |
| 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 |
| 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 |
Countries
Côte d’Ivoire
Outcome results
None listed