The Effect of Home-based Rehabilitation Program After COVID-19 Infection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Add-on telerehabilitation combined with usual home-based rehabilitation Add-on telerehabilitation combined with usual home-based rehabilitation |
Behavioral: Add-on telerehabilitation and home-based rehabilitation
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.
Add-on telerehabilitation for instruction and supervision of exercise training
|
| Experimental: Stand-alone usual home-based rehabilitation Stand-alone usual home-based rehabilitation |
Behavioral: Home-based rehabilitation alone
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.
|
| No Intervention: Usual care Usual care |
Outcome Measures
Primary Outcome Measures
- Change of 6-minute walking test (6MWT) and exercise capacity [The change in 6MWT and peak oxygen uptake will be measured at baseline, 12 weeks, 6 and 12 months after intervention.]
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.
Secondary Outcome Measures
- Dyspnea scale [The change in mMRC will be measured at baseline, 12 weeks, 6 and 12 months after intervention.]
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.
- Fatigue [The change in BFI will be measured at baseline, 12 weeks, 6 and 12 months after intervention.]
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.
- Depression and anxiety [The change in PHQ-9 and GAD-7 will be measured at baseline, 12 weeks, 6 and 12 months after intervention.]
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.
- Cognitive evaluation [The change in MoCA will be measured at baseline, 12 weeks, 6 and 12 months after intervention.]
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.
- Quality of life evaluation [The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.]
The investigators will assess the change in EuroQol-5D.
- Grip strength [The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.]
The investigators will assess the grip strength using a grip goniometer with the participants seated and the elbow flexed at 90 degree.
Eligibility Criteria
Criteria
Inclusion criteria:
-
≥ 20 years of age.
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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.
Exclusion criteria:
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Unable to cooperate with rehabilitation or evaluation.
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Dependent in basic activities of living before infection (Premorbid Barthel index <80).
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End stage patient, with life expectancy less than 1 year.
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Having contraindications for exercise according to the evaluation of a physician.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Hung-Jui Chuang, MD, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202106093RIND