An interventional study of Add-on telerehabilitation and home-based rehabilitation and Home-based rehabilitation alone in COVID-19, sponsored by National Taiwan University Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
The investigators will recruit the patients post-CoVID infection for a cardiopulmonary function evaluation and a home-based rehabilitation program. The investigators hypothesize that an add-on remote rehabilitation on a home-based rehabilitation has a better effect than a home-based rehabilitation alone on the compliance rate for the exercise, and also a better outcome in terms of cardiopulmonary function testing, 6-minute walking test, physical activities and quality of life, as well as less dyspnea, depression and anxiety.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 13 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion criteria:
Add-on telerehabilitation combined with usual home-based rehabilitation
Behavioral: Add-on telerehabilitation and home-based rehabilitation
Stand-alone usual home-based rehabilitation
Behavioral: Home-based rehabilitation alone
Usual care
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.
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.
Time frame: The change in 6MWT and peak oxygen uptake will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Dyspnea scale
The investigators will assess the change in the Modified Medical Research Council (mMRC) scale. The mMRC scale ranges from 0 to 4. Higher scores indicate worsen symptoms.
Time frame: The change in mMRC will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Fatigue
The investigators will assess the change in the Brief Fatigue Inventory (BFI). The total score of BFI ranges from 0 to 10. Higher scores indicate greater level of fatigue.
Time frame: The change in BFI will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Depression and anxiety
The investigators will assess the change in Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7). The PHQ-9 score ranges from 0-27 and the GAD-7 score ranges 0-21. Higher scores indicate worsen symptoms.
Time frame: The change in PHQ-9 and GAD-7 will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Cognitive evaluation
The investigators will assess the change in Montreal Cognitive Assessment (MoCA). The total score of MoCA ranges from 0 to 30. Higher scores indicate better cognitive function.
Time frame: The change in MoCA will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Quality of life evaluation
The investigators will assess the change in EuroQol-5D.
Time frame: The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Grip strength
The investigators will assess the grip strength using a grip goniometer with the participants seated and the elbow flexed at 90 degree.
Time frame: The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Plan to share: No
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This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital