3R Rehabilitation Management of COVID-19 Survivors
18 мая 2021 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
400
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Siu Ngor Fu, PhD
- Номер телефона: 852-27666726
- Электронная почта: amy.fu@polyu.edu.hk
Места учебы
-
-
-
Hong Kong, Гонконг
- Рекрутинг
- Pamela Youde Eastern Hospital
-
Контакт:
- Loletta So
- Номер телефона: 852-25956411
- Электронная почта: soky@ha.org.hk
-
Hong Kong, Гонконг
- Рекрутинг
- Princess Margaret Hospital
-
Контакт:
- Yiu Cheong Yeung
- Электронная почта: yeungyc@ha.org.hk
-
Hong Kong, Гонконг
- Рекрутинг
- Queen Elizabeth Hospital
-
Контакт:
- Wu Tak Chiu
- Номер телефона: 852-35062049
- Электронная почта: wutc@ha.org.hk
-
Hong Kong, Гонконг
- Рекрутинг
- Tuen Mun Hospital
-
Контакт:
- Yuk Yung Ng
- Электронная почта: ngyy3@ha.org.hk
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Fatigue measured by Fatigue Assessment Scale
Временное ограничение: 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
Временное ограничение: Baseline
|
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise
test.
|
Baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Muscle strength by 30-second double-leg sit-to-stand test (times)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Baseline
|
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
|
Baseline
|
|
Forced vital capacity (l)
Временное ограничение: 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
Временное ограничение: Baseline
|
Ratio of forced expiratory volume in one second and forced vital capacity
|
Baseline
|
|
FEV1/FVC
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Baseline
|
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
|
Baseline
|
|
Exercise capacity (m)
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: Siu Ngor Fu, PhD, The Hong Kong Polytechnic University
- Главный следователь: Loletta Kit-ying So, MD, Pamela Youde Eastern Hospital
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 октября 2020 г.
Первичное завершение (Ожидаемый)
31 марта 2022 г.
Завершение исследования (Ожидаемый)
31 марта 2022 г.
Даты регистрации исследования
Первый отправленный
1 марта 2021 г.
Впервые представлено, что соответствует критериям контроля качества
18 мая 2021 г.
Первый опубликованный (Действительный)
19 мая 2021 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
19 мая 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
18 мая 2021 г.
Последняя проверка
1 февраля 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HSEARS20200912001
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Нет
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .