Preliminary Situational Analysis of a Pilot Rehabilitation Intervention Based on Physical Exercise for People Living With HIV in Ivory Coast
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Functional capacity
研究概览
简要总结
The goal of this study is to document the impairment, functional and activity limitation and disability associated with HIV infection in an African urban context.
It will combine quantitative and a qualitative methods.
The quantitative evaluation will include 300 adults living with HIV of age ≥40 years receiving antiretroviral therapy and followed at the infectious disease department (SMIT), CHU de Treichville, Abidjan, and 200 adults without HIV infection of similar age and sex (control group). This cross-sectional evaluation will combine clinical, functional and cognitive evaluations and questionnaire on disability, depression and physical activity.
The qualitative research will be based on semi-directed interviews and will examine disability perception and biographic reconstruction.
详细描述
Background With the scale up of antiretroviral therapy (ART), people living with HIV (PLWHIV) life expectancy has increased dramatically over the last decades and HIV has become a chronic disease. However, the long-term infection with HIV is often associated with a number of health related challenges responsible of impairments and functional limitations. To achieve the ambitious objective that most of the PLWHIV receive ART and have a good quality of life, it is therefore necessary to address the HIV-related disability.
Objectives This research aims to provide a comprehensive analysis of the frequency and nature of the impairments and functional limitation occurring in PLWHIV, and of their impact on participants lives. It will also assess the level of physical activity and the acceptability of an intervention based on physical activity.
It will adopt a multidisciplinary approach, which will combine objective and subjective measurements of disability including bio-clinical data, epidemiological data and qualitative data reflecting PLWHIV's perspective. It will also include an evaluation of the a priori acceptability of using physical exercise with PLWHIV.
Three dimensions of disability will be considered in the analysis: 1) impairment and morbidities (neurological, motor and cognitive), 2) activities (or functional) limitations, 3) social participation restrictions. The evaluation of acceptability will cover perceived relevance, adequacy, perceived efficacy and easiness of use of the intervention.
Design and methods The quantitative evaluation will include 300 PLWHIV receiving ART and followed at the infectious disease department (SMIT), CHU de Treichville, Abidjan. A control group of HV uninfected adults will also be included (n = 150). This cross-sectional evaluation will combine clinical, functional and cognitive evaluations and questionnaire on disability (WHODAS, HDQ), depression (PHQ-9) and physical exercise acceptability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥40 years
- •HIV-1 infection (or negative HIV test within the last 12 months if control)
- •Ongoing antiretroviral treatment if HIV-infected participant
排除标准
- •Clinical symptoms suggesting an acute infection
- •Any severe condition not allowing participation in the study
结局指标
主要结局
Functional capacity
时间窗: Baseline
Short Physical Performance battery (SPPB)
次要结局
- Comorbidities: diabetes(Baseline)
- Comorbidities: obesity(Baseline)
- Neurologic outcomes CNS(Baseline)
- Neurologic outcomes BNPS(Baseline)
- Other functional scores: gate speed(Baseline)
- Physical activity(Baseline)
- Cognitive tests: memory(Baseline)
- Disability: Instrumental Activities of Daily Life (IADL)(Baseline)
- Cognitive tests: Digit symbol substitution test (DSST)(Baseline)
- Other functional scores: fine motricity(Baseline)
- Cognitive tests: color trail(Baseline)
- Cognitive tests: fluency test(Baseline)
- Disability: HIV Disability Questionnaire (HDQ)(Baseline)
- Mental health: depression(Baseline)
- Acceptability and preference for an intervention(Baseline)
- Other functional scores: strength(Baseline)
- Comorbidities: blood pressure(Baseline)
- Cognitive tests: digit span test (DST)(Baseline)
- Disability: WHO Disability Assessment Schedule 2 (WHODAS)(Baseline)