Efficacy of Teletechnology-assisted Home-based Exercise Program for Severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Six-minute walk distance
研究概览
简要总结
The aim of this study was to investigate the efficacy of a home-based pulmonary rehabilitation program with the support of teletechnology in COVID-19 survivors. The main questions it aims to answer were:
- The change of six-minute walk distance
- The change of time of one-minute sit-to-stand test
- The change of maximal strength of upper-limb, lower-limb and respiratory muscle
- The change of quality of life Participants in the home-based pulmonary rehabilitation group received teletechnology-assisted consultations (either by videotelephony or telephone calls) for every 1-2 weeks during the intervention period, and participants in the usual care group did not receive teletechnology-assisted consultations during the intervention period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are 20 years or more with severe (severe pneumonia) to critical (acute respiratory distress syndrome, sepsis, or septic shock) COVID-19 during hospitalization after deisolation.
- •Patients are 65 years or more, or ever receiving oral antiviral treatment after deisolation.
- •Patient have the ability to ambulate on level surface without direct contact of another person, have telecommunication device(s), and provide consent to receive teletechnology-assisted rehabilitation.
排除标准
- •Patients are pregnant or planning for pregnancy.
- •Patients have cognitive dysfunction, learning disability, uncontrolled arrhythmia or hypertension, or any medical diagnosis other than COVID-19 that would prominently influence their ability to follow instructions and perform exercise.
研究组 & 干预措施
Home-based pulmonary rehabilitation group
The home-based pulmonary rehabilitation group received breathing exercise instructions using online learning materials soon after randomization. The participants received a home-based exercise plan, which comprised aerobic exercise and resistance exercise with instruction sheets. Teletechnology was incorporated into home-based pulmonary rehabilitation via videotelephony (or telephone calls if indicated). Time points for these teletechnology-assisted consultations were at day 7, day 14 after randomization and every 2 weeks after that until the completion of the study (week 12).
干预措施: Teletechnology-assisted home-based pulmonary rehabilitation (Behavioral)
Usual care group
The usual care group will receive breathing exercise instructions using online learning materials soon after randomization. The participants will also receive general exercise education and exercise safety principles but not any consultation about their physical activity/exercise during the study period.
干预措施: Teletechnology-assisted home-based pulmonary rehabilitation (Behavioral)
结局指标
主要结局
Six-minute walk distance
时间窗: Week 24
The distance of six-minute walk test
Six-minute walk distance
时间窗: Week 0
The distance of six-minute walk test
Six-minute walk distance
时间窗: Week 4
The distance of six-minute walk test
Six-minute walk distance
时间窗: Week 8
The distance of six-minute walk test
Six-minute walk distance
时间窗: Week 12
The distance of six-minute walk test
次要结局
- Maximal lower limb strength(Week 24)
- Quality of life score(Week 24)
- Maximal respiratory muscle strength(Week 24)
- Maximal upper limb strength(Week 24)
- Maximal upper limb strength(Week 0)
- Maximal upper limb strength(Week 4)
- Maximal upper limb strength(Week 8)
- Maximal upper limb strength(Week 12)
- Maximal lower limb strength(Week 0)
- Maximal lower limb strength(Week 4)
- Maximal lower limb strength(Week 8)
- Maximal lower limb strength(Week 12)
- Maximal respiratory muscle strength(Week 0)
- Maximal respiratory muscle strength(Week 4)
- Maximal respiratory muscle strength(Week 8)
- Maximal respiratory muscle strength(Week 12)
- Quality of life score(Week 0)
- Quality of life score(Week 4)
- Quality of life score(Week 8)
- Quality of life score(Week 12)
研究者
National Taiwan University Clinical Trial Center
Mr. Ping-Lun Hsieh
National Taiwan University Hospital