Feasibility and Benefit of a Telerehabilitation Program in Human Immunodeficiency Virus-infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Retention rate
研究概览
简要总结
The aim of this study is to assess the feasibility and the effects of a 6-week telerehabilitation on the three domains of the International Classification of Functioning, Disability and Health in HIV-infected patients under highly active antiretroviral therapy (HAART).
HIV-infected patients were randomized either into an Endurance and Resistance Training Exercise (ERTE) group or a control (CON) group. Telerehabilitation was realized in a public fitness center, with online guidance and weekly telephone advice, 3 times per week for 6 weeks. Feasibility was determined by recruitment rate, retention rate and adverse events. Secondary outcomes were impact on body composition, inflammation and coagulation (C-reactive protein, D-dimer), physical fitness and quality of life (WHOQOL-HIV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •under HAART treatment
- •native French speaker
排除标准
- •AIDS diagnosis
- •physical and/or psychiatric impairments that seriously impaired physical activity
- •Unstable (defined by any modification of health outcomes during the last 6 months).
研究组 & 干预措施
Endurance and Resistance Training Exercise
干预措施: Endurance ad Resistance Training Exercise (Behavioral)
Control group
Usual care
结局指标
主要结局
Retention rate
时间窗: At study completion (after 6 weeks)
Percentage of patients lost to follow-up
Adverse events
时间窗: At study completion (after 6 weeks)
Percentage of patients who experienced one or more adverse events
Recruitment rate
时间窗: At study completion (after 6 weeks)
Number of eligible participants who enrolled in the program out of the number were recruited
次要结局
- Weight(Assessments at baseline and at 6 weeks)
- D-dimer(Assessments at baseline and at 12 weeks)
- Lean body mass(Assessments at baseline and at 6 weeks)
- Fat body mass(Assessments at baseline and at 6 weeks)
- C-reactive protein(Assessments at baseline and at 12 weeks)
- CD4+ T cell counts(Assessments at baseline and at 12 weeks)
- Viral load(Assessments at baseline and at 12 weeks)
- Lower body muscular strength(Assessments at baseline and at 6 weeks)
- Functional exercise capacity(Assessments at baseline and at 6 weeks)
- Flexibility(Assessments at baseline and at 6 weeks)
- Upper limb strength(Assessments at baseline and at 6 weeks)
- Quality of life(Assessments at baseline and at 6 weeks)
研究者
Caty
Principal Investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain