Clinical trial NCT04892979: 3R Rehabilitation Management of COVID-19 Survivors
Official title: 3R Rehabilitation Management of COVID-19 Survivors Using Centre-based and Online-based Approaches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Pamela Youde Nethersole Eastern Hospital, Hong Kong
name: Queen Elizabeth Hospital, Hong Kong
name: Princess Margaret Hospital, Hong Kong
name: Tuen Mun Hospital Hong Kong
First posted: 2021-05-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fatigue measured by Fatigue Assessment Scale
timeFrame: 6 weeks after the start of intervention
measure: Fatigue measured by Fatigue Assessment Scale
timeFrame: Baseline
Secondary outcomes:
measure: Muscle strength by 30-second double-leg sit-to-stand test (times)
timeFrame: Baseline
measure: Muscle strength by 30-second double-leg sit-to-stand test (times)
timeFrame: 6 weeks after the start of intervention
measure: Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
timeFrame: Baseline
measure: Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
timeFrame: 6 weeks after the start of intervention
measure: Self-perceived quality of life by The St. George's Respiratory Questionnaire-HK version
timeFrame: Baseline
measure: Self-perceived quality of life by The St. George's Respiratory Questionnaire-HK version
timeFrame: 6 weeks after the start of intervention
measure: Self-perceived quality of life by The Hong Kong Chinese version Short Form-36
timeFrame: Baseline
measure: Self-perceived quality of life by The Hong Kong Chinese version Short Form-36
timeFrame: 6 weeks after the start of intervention
measure: Cardiac output (L/min)
timeFrame: Baseline
measure: Cardiac output (L/min)
timeFrame: 6 weeks after the start of intervention
measure: Cardiac stroke volume (ml/m2)
timeFrame: Baseline
measure: Cardiac stroke volume (ml/m2)
timeFrame: 6 weeks after the start of intervention
measure: Forced expiratory volume in one second (l)
timeFrame: Baseline
measure: Forced expiratory volume in one second (l)
timeFrame: 6 weeks after the start of intervention
measure: Forced vital capacity (l)
timeFrame: Baseline
measure: Forced vital capacity (l)
timeFrame: 6 weeks after the start of intervention
measure: FEV1/FVC
timeFrame: Baseline
measure: FEV1/FVC
timeFrame: 6 weeks after the start of intervention
measure: Peak expiratory flow rate (l/s)
timeFrame: Baseline
measure: Peak expiratory flow rate (l/s)
timeFrame: 6 weeks after the start of intervention
measure: Exercise capacity (m)
timeFrame: Baseline
measure: Exercise capacity (m)
timeFrame: 6 weeks after the start of intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Siu Ngor Fu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamela Youde Eastern Hospital
name: Loletta Kit-ying So, MD
role: PRINCIPAL_INVESTIGATOR
References: