Feasibility and Effectiveness of a Pilot Program of Physical Activity to Improve Functional Limitations and Disability in HIV-infected Adults Older Than 50 From Côte d'Ivoire
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Performance at the 6 minute step-up test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •SPPB score between 4 and
- •Signed informed consent.
排除标准
- •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.
- •Age ≥40 years
- •Negative HIV test within the last 12 months;
- •Living in Abobo area
- •Written consent to participate to the study
- •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
- •Any clinical symptoms suggesting an acute infection
- •Any life-threatening pathology in the short term or any pathology not allowing participation in the study
研究组 & 干预措施
Groupes-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).
干预措施: Physical activity programme (Behavioral)
Home-based arm
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.
干预措施: Home-based physical activity (Behavioral)
Control arm
Health education session every months.
结局指标
主要结局
Performance at the 6 minute step-up test
时间窗: Baseline, Month 6 and Month 12
Number of ascent-descent cycles counted over 6 minutes
Performance at the 6 minute step-up test
时间窗: Baseline, Month 6 and Month 12
Number of ascent-descent cycles counted over 6 minutes
次要结局
- Satisfaction and acceptability of physical activity(Week 12, Month 6 and Month 12)
- Performance at the 6 minute walking test(Baseline and Month 12)
- Performances at the 6 minute stand up test(Baseline, Month 6)
- Performances at the Y balance Test(Baseline)
- Grip strength(Baseline, Month 6 and Month 12)
- WHO Disability Assessment Schedule - 2.0 (WHODAS) score(Baseline and Month 12)
- HIV Disability Questionnaire - short form (HDQ-SF) score(Day 0)
- Short Physical Performance Battery (SPPB) score(Baseline and Month 12)
- Scores of the Neuroscreen app tests(Baseline and Month 12)
- Fasting blood glucose(Baseline and Month 12)
- IDIR test(Baseline, Month 6 and Month 12)
- WHO-QoL(Baseline, Month 6 and Month 12)
- PHQ-9(Baseline, Month 6 and Month 12)
- PHQ-9(Baseline, Month 6 and Month 12)
- WHO-QoL(Baseline, Month 6 and Month 12)
- IDIR test(Baseline, Month 6 and Month 12)
- Performance at the 6 minute walking test(Baseline and Month 12)
- Performances at the 6 minute stand up test(Baseline, Month 6)
- Performances at the Y balance Test(Baseline)
- Grip strength(Baseline, Month 6 and Month 12)
- WHO Disability Assessment Schedule - 2.0 (WHODAS) score(Baseline and Month 12)
- HIV Disability Questionnaire - short form (HDQ-SF) score(Day 0)
- Short Physical Performance Battery (SPPB) score(Baseline and Month 12)
- Scores of the Neuroscreen app tests(Baseline and Month 12)
- Fasting blood glucose(Baseline and Month 12)
- Satisfaction and acceptability of physical activity(Week 12, Month 6 and Month 12)