3R Rehabilitation Management of COVID-19 Survivors
2021年5月18日 更新者：The Hong Kong Polytechnic University
3R Rehabilitation Management of COVID-19 Survivors Using Centre-based and Online-based Approaches
It is to explore the temporal relationships between physical fitness, cognitive, psychosocial functions, and health-related quality of life (HRQoL) in COVID-19 survivors over the first 15 months; and to determine the effects of centre-based (CBR), online-based cardiopulmonary rehabilitation (OBR), and combined centre- and online-based rehabilitation (COBR) on survivors with initially suboptimal pulmonary functions.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (预期的)
400
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Siu Ngor Fu, PhD
- 电话号码：852-27666726
- 邮箱：amy.fu@polyu.edu.hk
学习地点
-
-
-
Hong Kong、香港
- 招聘中
- Pamela Youde Eastern Hospital
-
接触：
- Loletta So
- 电话号码：852-25956411
- 邮箱：soky@ha.org.hk
-
Hong Kong、香港
- 招聘中
- Princess Margaret Hospital
-
接触：
- Yiu Cheong Yeung
- 邮箱：yeungyc@ha.org.hk
-
Hong Kong、香港
- 招聘中
- Queen Elizabeth Hospital
-
接触：
- Wu Tak Chiu
- 电话号码：852-35062049
- 邮箱：wutc@ha.org.hk
-
Hong Kong、香港
- 招聘中
- Tuen Mun Hospital
-
接触：
- Yuk Yung Ng
- 邮箱：ngyy3@ha.org.hk
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- COVID survivor at hospital discharge or 6-month post-disease onset
- Medically stable with an Abbreviated Mental Test (AMT) scores of > 6 out of 10
Exclusion Criteria:
- Having contraindications to exercise
- Physical Activity Readiness Questionnaire (PAR-Q) reveals unsafety
- Cannot understand Cantonese
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 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 |
|---|---|
|
实验性的：Centre-based
Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks
|
Depending on the preference of participants, they can either choose to join three 60-minute centre-based sessions plus two sessions of 30-minute home exercise per week, or two 60-minute centre-based sessions plus four sessions of 30-minute home exercise per week.
Each session will include warm-up and cool-down exercises, aerobic exercises, and progressive strengthening exercises prescribed based on individual ability (Table 1).
Aerobic exercises will be performed at 60-75% (up to 85% for fit individuals) of the predicted maximum heart rate.
The respective rate of perceived exertion during exercise will be maintained between 4 and 6 out of 10 on the Borg CR scale [10], indicating moderate to strenuous exercise levels.
Additionally, physiotherapists will provide education related to COVID-19, energy conservation, and stress management during the program.
|
|
实验性的：Online-based
Online-based exercise cardiopulmonary rehabilitation program for 6 weeks
|
Participants in the OBR group will attend one face-to-face session to learn how to use a mobile application (app) followed by 6 weeks of home exercises.
The online treatments will be delivered via the Caspar Health e-system, a German-designed Internet-based system, is available for desktop PCs and as a mobile app for both iOS and Android smartphones.
This system will enable patients to follow their therapists' treatment plans in an asynchronous manner.
The OBR programme will last for 6 weeks.
Participants will be instructed to perform 40 minutes of structured exercises 6 times per week.
In the first week, six 40-minute online exercise sessions will be delivered through push notifications on the mobile app.
|
|
实验性的：Combined
Combined centre- and online-based exercise cardiopulmonary rehabilitation program for 6 weeks
|
Depending on the preference of participants, they can either choose to join three 60-minute centre-based sessions plus two sessions of 30-minute home exercise per week, or two 60-minute centre-based sessions plus four sessions of 30-minute home exercise per week.
Each session will include warm-up and cool-down exercises, aerobic exercises, and progressive strengthening exercises prescribed based on individual ability (Table 1).
Aerobic exercises will be performed at 60-75% (up to 85% for fit individuals) of the predicted maximum heart rate.
The respective rate of perceived exertion during exercise will be maintained between 4 and 6 out of 10 on the Borg CR scale [10], indicating moderate to strenuous exercise levels.
Additionally, physiotherapists will provide education related to COVID-19, energy conservation, and stress management during the program.
Participants in the OBR group will attend one face-to-face session to learn how to use a mobile application (app) followed by 6 weeks of home exercises.
The online treatments will be delivered via the Caspar Health e-system, a German-designed Internet-based system, is available for desktop PCs and as a mobile app for both iOS and Android smartphones.
This system will enable patients to follow their therapists' treatment plans in an asynchronous manner.
The OBR programme will last for 6 weeks.
Participants will be instructed to perform 40 minutes of structured exercises 6 times per week.
In the first week, six 40-minute online exercise sessions will be delivered through push notifications on the mobile app.
|
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 |
|---|---|---|
|
Fatigue measured by Fatigue Assessment Scale
大体时间：6 weeks after the start of intervention
|
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise
test.
|
6 weeks after the start of intervention
|
|
Fatigue measured by Fatigue Assessment Scale
大体时间：Baseline
|
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise
test.
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Muscle strength by 30-second double-leg sit-to-stand test (times)
大体时间：Baseline
|
Muscle strength will be assessed with the 30-second double-leg sit-to-stand test.
If the participant can perform the 30-second single leg sit-to-stand test with pain or difficulty, they will be invited to complete 30-second single-leg sit-to-stand test.
The number of completed repetitions will be counted.
|
Baseline
|
|
Muscle strength by 30-second double-leg sit-to-stand test (times)
大体时间：6 weeks after the start of intervention
|
Muscle strength will be assessed with the 30-second double-leg sit-to-stand test.
If the participant can perform the 30-second single leg sit-to-stand test with pain or difficulty, they will be invited to complete 30-second single-leg sit-to-stand test.
The number of completed repetitions will be counted.
|
6 weeks after the start of intervention
|
|
Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
大体时间：Baseline
|
A six-item digital self-administered self-efficacy questionnaire will be used to evaluate patients' confidence in performing exercise, managing their own symptoms and emotions and completing their daily tasks.
|
Baseline
|
|
Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
大体时间：6 weeks after the start of intervention
|
A six-item digital self-administered self-efficacy questionnaire will be used to evaluate patients' confidence in performing exercise, managing their own symptoms and emotions and completing their daily tasks.
|
6 weeks after the start of intervention
|
|
Self-perceived quality of life by The St. George's Respiratory Questionnaire-HK version
大体时间：Baseline
|
The St. George's Respiratory Questionnaire-HK version is a self-reported questionnaire.
This 50-item disease specific questionnaire assesses 3 domains (symptoms, activity, and impacts).
|
Baseline
|
|
Self-perceived quality of life by The St. George's Respiratory Questionnaire-HK version
大体时间：6 weeks after the start of intervention
|
The St. George's Respiratory Questionnaire-HK version is a self-reported questionnaire.
This 50-item disease specific questionnaire assesses 3 domains (symptoms, activity, and impacts).
|
6 weeks after the start of intervention
|
|
Self-perceived quality of life by The Hong Kong Chinese version Short Form-36
大体时间：Baseline
|
The Hong Kong Chinese version Short Form-36 is a concise 36-item health status questionnaire with good psychometric properties.
|
Baseline
|
|
Self-perceived quality of life by The Hong Kong Chinese version Short Form-36
大体时间：6 weeks after the start of intervention
|
The Hong Kong Chinese version Short Form-36 is a concise 36-item health status questionnaire with good psychometric properties.
|
6 weeks after the start of intervention
|
|
Cardiac output (L/min)
大体时间：Baseline
|
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall by a non-invasive measurement of cardiac output using the CardioScreen 1000 System.
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall bilaterally
|
Baseline
|
|
Cardiac output (L/min)
大体时间：6 weeks after the start of intervention
|
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall by a non-invasive measurement of cardiac output using the CardioScreen 1000 System.
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall bilaterally
|
6 weeks after the start of intervention
|
|
Cardiac stroke volume (ml/m2)
大体时间：Baseline
|
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall by a non-invasive measurement of cardiac output using the CardioScreen 1000 System.
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall bilaterally
|
Baseline
|
|
Cardiac stroke volume (ml/m2)
大体时间：6 weeks after the start of intervention
|
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall by a non-invasive measurement of cardiac output using the CardioScreen 1000 System.
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall bilaterally
|
6 weeks after the start of intervention
|
|
Forced expiratory volume in one second (l)
大体时间：Baseline
|
FEV1 is the volume of air that can forcibly be blown out in first 1 second, after full inspiration
|
Baseline
|
|
Forced expiratory volume in one second (l)
大体时间：6 weeks after the start of intervention
|
FEV1 is the volume of air that can forcibly be blown out in first 1 second, after full inspiration
|
6 weeks after the start of intervention
|
|
Forced vital capacity (l)
大体时间：Baseline
|
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
|
Baseline
|
|
Forced vital capacity (l)
大体时间：6 weeks after the start of intervention
|
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
|
6 weeks after the start of intervention
|
|
FEV1/FVC
大体时间：Baseline
|
Ratio of forced expiratory volume in one second and forced vital capacity
|
Baseline
|
|
FEV1/FVC
大体时间：6 weeks after the start of intervention
|
Ratio of forced expiratory volume in one second and forced vital capacity
|
6 weeks after the start of intervention
|
|
Peak expiratory flow rate (l/s)
大体时间：Baseline
|
Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration
|
Baseline
|
|
Peak expiratory flow rate (l/s)
大体时间：6 weeks after the start of intervention
|
Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration
|
6 weeks after the start of intervention
|
|
Exercise capacity (m)
大体时间：Baseline
|
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
|
Baseline
|
|
Exercise capacity (m)
大体时间：6 weeks after the start of intervention
|
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
|
6 weeks after the start of intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Siu Ngor Fu, PhD、The Hong Kong Polytechnic University
- 首席研究员：Loletta Kit-ying So, MD、Pamela Youde Eastern Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年10月1日
初级完成 (预期的)
2022年3月31日
研究完成 (预期的)
2022年3月31日
研究注册日期
首次提交
2021年3月1日
首先提交符合 QC 标准的
2021年5月18日
首次发布 (实际的)
2021年5月19日
研究记录更新
最后更新发布 (实际的)
2021年5月19日
上次提交的符合 QC 标准的更新
2021年5月18日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.