- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04892979
3R Rehabilitation Management of COVID-19 Survivors
18 maj 2021 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
400
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Siu Ngor Fu, PhD
- Telefonnummer: 852-27666726
- E-post: amy.fu@polyu.edu.hk
Studieorter
-
-
-
Hong Kong, Hong Kong
- Rekrytering
- Pamela Youde Eastern Hospital
-
Kontakt:
- Loletta So
- Telefonnummer: 852-25956411
- E-post: soky@ha.org.hk
-
Hong Kong, Hong Kong
- Rekrytering
- Princess Margaret Hospital
-
Kontakt:
- Yiu Cheong Yeung
- E-post: yeungyc@ha.org.hk
-
Hong Kong, Hong Kong
- Rekrytering
- Queen Elizabeth Hospital
-
Kontakt:
- Wu Tak Chiu
- Telefonnummer: 852-35062049
- E-post: wutc@ha.org.hk
-
Hong Kong, Hong Kong
- Rekrytering
- Tuen Mun Hospital
-
Kontakt:
- Yuk Yung Ng
- E-post: ngyy3@ha.org.hk
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Experimentell: 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.
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Fatigue measured by Fatigue Assessment Scale
Tidsram: 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
Tidsram: Baseline
|
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise
test.
|
Baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Muscle strength by 30-second double-leg sit-to-stand test (times)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline
|
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
|
Baseline
|
Forced vital capacity (l)
Tidsram: 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
Tidsram: Baseline
|
Ratio of forced expiratory volume in one second and forced vital capacity
|
Baseline
|
FEV1/FVC
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline
|
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
|
Baseline
|
Exercise capacity (m)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Siu Ngor Fu, PhD, The Hong Kong Polytechnic University
- Huvudutredare: Loletta Kit-ying So, MD, Pamela Youde Eastern Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 oktober 2020
Primärt slutförande (Förväntat)
31 mars 2022
Avslutad studie (Förväntat)
31 mars 2022
Studieregistreringsdatum
Först inskickad
1 mars 2021
Först inskickad som uppfyllde QC-kriterierna
18 maj 2021
Första postat (Faktisk)
19 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 maj 2021
Senast verifierad
1 februari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HSEARS20200912001
Plan för individuella deltagardata (IPD)
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produkt tillverkad i och exporterad från U.S.A.
Nej
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