Feasibility of Telerehabilitation in HIV-patients
Feasibility and Benefit of a Telerehabilitation Program in Human Immunodeficiency Virus-infected Patients
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).
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years or older
- under HAART treatment
- native French speaker
Exclusion Criteria:
- AIDS diagnosis
- physical and/or psychiatric impairments that seriously impaired physical activity
- pregnant
- Unstable (defined by any modification of health outcomes during the last 6 months).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：控制组
日常护理
|
|
|
实验性的：Endurance and Resistance Training Exercise
|
Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment rate
大体时间：At study completion (after 6 weeks)
|
Number of eligible participants who enrolled in the program out of the number were recruited
|
At study completion (after 6 weeks)
|
|
Retention rate
大体时间：At study completion (after 6 weeks)
|
Percentage of patients lost to follow-up
|
At study completion (after 6 weeks)
|
|
Adverse events
大体时间：At study completion (after 6 weeks)
|
Percentage of patients who experienced one or more adverse events
|
At study completion (after 6 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weight
大体时间：Assessments at baseline and at 6 weeks
|
Weight (kg) is measured by using a bioelectrical impedance analysis
|
Assessments at baseline and at 6 weeks
|
|
Lean body mass
大体时间：Assessments at baseline and at 6 weeks
|
Lean body mass (kg) is measured by using a bioelectrical impedance analysis
|
Assessments at baseline and at 6 weeks
|
|
Fat body mass
大体时间：Assessments at baseline and at 6 weeks
|
Lean body mass (kg) is measured by using a bioelectrical impedance analysis
|
Assessments at baseline and at 6 weeks
|
|
C-reactive protein
大体时间：Assessments at baseline and at 12 weeks
|
C-reactive protein is measured by a blood test
|
Assessments at baseline and at 12 weeks
|
|
D-dimer
大体时间：Assessments at baseline and at 12 weeks
|
D-dimer is measured by a blood test
|
Assessments at baseline and at 12 weeks
|
|
CD4+ T cell counts
大体时间：Assessments at baseline and at 12 weeks
|
CD4+ T cell counts is measured by a blood test
|
Assessments at baseline and at 12 weeks
|
|
Viral load
大体时间：Assessments at baseline and at 12 weeks
|
Viral load is measured by a blood test
|
Assessments at baseline and at 12 weeks
|
|
Functional exercise capacity
大体时间：Assessments at baseline and at 6 weeks
|
Functional exercise capacity is measured by a 6-minute walk test
|
Assessments at baseline and at 6 weeks
|
|
Flexibility
大体时间：Assessments at baseline and at 6 weeks
|
Flexibility is measured by Toe touch test and sit and reach test
|
Assessments at baseline and at 6 weeks
|
|
Lower body muscular strength
大体时间：Assessments at baseline and at 6 weeks
|
Lower body muscular strength is measured by 30-s chair-stand test
|
Assessments at baseline and at 6 weeks
|
|
Upper limb strength
大体时间：Assessments at baseline and at 6 weeks
|
Upper limb strength is measured by hand grip strength tool
|
Assessments at baseline and at 6 weeks
|
|
Quality of life
大体时间：Assessments at baseline and at 6 weeks
|
Quality of life is measured by World Health Organization Quality of Life HIV Instrument
|
Assessments at baseline and at 6 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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