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3R Rehabilitation Management of COVID-19 Survivors

2021년 5월 18일 업데이트: 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.

연구 개요

상태

모병

정황

코로나19

개입 / 치료

연구 유형

중재적

등록 (예상)

400

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Siu Ngor Fu, PhD
전화번호: 852-27666726
이메일: amy.fu@polyu.edu.hk

연구 장소

홍콩
- - Hong Kong, 홍콩
    - 모병
    - Pamela Youde Eastern Hospital
    - 연락하다:
      
      Loletta So
      
      전화번호: 852-25956411
      
      이메일: soky@ha.org.hk
  - Hong Kong, 홍콩
    - 모병
    - Princess Margaret Hospital
    - 연락하다:
      
      Yiu Cheong Yeung
      
      이메일: yeungyc@ha.org.hk
  - Hong Kong, 홍콩
    - 모병
    - Queen Elizabeth Hospital
    - 연락하다:
      
      Wu Tak Chiu
      
      전화번호: 852-35062049
      
      이메일: wutc@ha.org.hk
  - Hong Kong, 홍콩
    - 모병
    - Tuen Mun Hospital
    - 연락하다:
      
      Yuk Yung Ng
      
      이메일: ngyy3@ha.org.hk

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위화되지 않음
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: Centre-based Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks	다른: Cardiopulmonary exercise (centre-based) 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.
실험적: Online-based Online-based exercise cardiopulmonary rehabilitation program for 6 weeks	다른: Cardiopulmonary exercise (online-based) 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.
실험적: Combined Combined centre- and online-based exercise cardiopulmonary rehabilitation program for 6 weeks	다른: Cardiopulmonary exercise (centre-based) 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. 다른: Cardiopulmonary exercise (online-based) 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Fatigue measured by Fatigue Assessment Scale 기간: 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 기간: Baseline	The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test.	Baseline

2차 결과 측정

결과 측정	측정값 설명	기간
Muscle strength by 30-second double-leg sit-to-stand test (times) 기간: 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) 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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) 기간: 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) 기간: 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) 기간: 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) 기간: 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) 기간: 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) 기간: 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) 기간: Baseline	Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration	Baseline
Forced vital capacity (l) 기간: 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 기간: Baseline	Ratio of forced expiratory volume in one second and forced vital capacity	Baseline
FEV1/FVC 기간: 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) 기간: 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) 기간: 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) 기간: Baseline	Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.	Baseline
Exercise capacity (m) 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

The Hong Kong Polytechnic University

협력자

Queen Elizabeth Hospital, Hong Kong

Pamela Youde Nethersole Eastern Hospital, Hong Kong

Princess Margaret Hospital, Hong Kong

Tuen Mun Hospital Hong Kong

수사관

수석 연구원: Siu Ngor Fu, PhD, The Hong Kong Polytechnic University
수석 연구원: Loletta Kit-ying So, MD, Pamela Youde Eastern Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 10월 1일

기본 완료 (예상)

2022년 3월 31일

연구 완료 (예상)

2022년 3월 31일

연구 등록 날짜

최초 제출

2021년 3월 1일

QC 기준을 충족하는 최초 제출

2021년 5월 18일

처음 게시됨 (실제)

2021년 5월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 5월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 5월 18일

마지막으로 확인됨

2021년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

HSEARS20200912001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

코로나19에 대한 임상 시험

HealthQuilt

완전한

Nerium Oleander가 면역 기능에 미치는 영향

면역 기능 | Covid19 양성 환자 | Covid19 긴밀한 접촉

미국
Bahçeşehir University

완전한

포스트 코로나 증후군으로 인한 자율신경계 애정

긴 Covid19 | 자율신경장애

칠면조
Texas Woman's University
National Institutes of Health (NIH)

아직 모집하지 않음

프랑스어를 사용하는 아프리카 출생 이민자를 위한 맞춤형 COVID-19 검사 지원 계획

COVID19 테스트
Cairo University
Kasr El Aini Hospital

알려지지 않은

COVID-19 폐렴의 예후 표지자로서의 N-말단 Pro B-type Natriuretic Peptide와 비타민 D 수치

COVID19 폐렴

이집트
Assistance Publique - Hôpitaux de Paris

알려지지 않은

Corimmuno-19 코호트에 내포된 COVID-19 감염 환자에서 항응고제의 효능 및 안전성을 평가하는 시험 (CORIMMUNO-COAG)

COVID19 폐렴

프랑스
Aarhus University Hospital
University of Aarhus; Pharma Nord

완전한

장기 COVID-19 치료제로서의 코엔자임 Q10 (QVID)

코로나19 | 장기 Covid19

덴마크
Neuromed IRCCS

빼는

감별 백혈구 수 및 Covid-19 진단

SARS-CoV-2 감염 Covid19

이탈리아
Lumos Diagnostics
Rapid Pathogen Screening

완전한

Fingerstick 전혈에서 POC(Point-of-Care), SARS-CoV-2(COVID-19) IgG 항체 검사의 임상 평가

SARS-Cov-2, Covid19

미국
Vasomune Therapeutics, Inc.

완전한

건강한 피험자에서 AV-001에 대한 최초의 인간 연구

코로나19 | 급성호흡곤란증후군 | Covid19 관련 ARDS

미국
Enzychem Lifesciences Corporation

모병

중증 폐렴 또는 ARDS에 대한 COVID-19 감염 예방

Covid19 폐렴

미국

3R Rehabilitation Management of COVID-19 Survivors