Study Stopped
Recruitment difficulties and insufficient funding.
The Effect of Home-based Rehabilitation Program After COVID-19 Infection
The Cardiopulmonary Function Outcome and the Effect of Two Modules of Home-based Rehabilitation Programs in Patients After COVID-19 Infection - A Randomized and Controlled Trial.
1 other identifier
interventional
13
1 country
1
Brief Summary
To follow up the cardiopulmonary function after coronavirus disease 2019 (CoVID-19) infection and compare the effect of a 12-week home-based cardiopulmonary with or without add-on remote rehabilitation on the cardiopulmonary function, emotion and quality of outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Jul 2021
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2021
CompletedFirst Submitted
Initial submission to the registry
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2025
CompletedFebruary 19, 2025
February 1, 2025
2.6 years
March 31, 2022
February 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of 6-minute walking test (6MWT) and exercise capacity
The distance of a 6-minute walking test and peak oxygen uptake according to cardiopulmonary exercise test will be assessed before intervention (12-week rehabilitation course), 12 weeks, 6 months and 12 months after intervention.
The change in 6MWT and peak oxygen uptake will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Secondary Outcomes (6)
Dyspnea scale
The change in mMRC will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Fatigue
The change in BFI will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Depression and anxiety
The change in PHQ-9 and GAD-7 will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Cognitive evaluation
The change in MoCA will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Quality of life evaluation
The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
- +1 more secondary outcomes
Study Arms (3)
Add-on telerehabilitation combined with usual home-based rehabilitation
EXPERIMENTALAdd-on telerehabilitation combined with usual home-based rehabilitation
Stand-alone usual home-based rehabilitation
EXPERIMENTALStand-alone usual home-based rehabilitation
Usual care
NO INTERVENTIONUsual care
Interventions
1. 12wk home-based rehabilitation including individualized exercise training and inspiratory muscle training with symptoms monitoring. Participants will be provided with a manual and routine telephone follow-up by a case manager. 2. Add-on telerehabilitation for instruction and supervision of exercise training
12wk home-based rehabilitation including individualized exercise training and inspiratory muscle training with symptoms monitoring. Participants will be provided with a manual and routine telephone follow-up by a case manager.
Eligibility Criteria
You may qualify if:
- ≥ 20 years of age.
- COVID-19 survivor after de-isolation at post-acute stage about to be discharged or already at outpatient follow-up who still have symptoms or exercise intolerance.
You may not qualify if:
- Unable to cooperate with rehabilitation or evaluation.
- Dependent in basic activities of living before infection (Premorbid Barthel index \<80).
- End stage patient, with life expectancy less than 1 year.
- Having contraindications for exercise according to the evaluation of a physician.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hung-Jui Chuang, MD
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2022
First Posted
April 8, 2022
Study Start
July 15, 2021
Primary Completion
February 17, 2024
Study Completion
February 17, 2025
Last Updated
February 19, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share