The Effect of Home-based Rehabilitation Program After COVID-19 Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: Add-on telerehabilitation and home-based rehabilitation
* Behavioral: Home-based rehabilitation alone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: ≥ 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. Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Add-on telerehabilitation combined with usual home-based rehabilitation<br>Add-on telerehabilitation combined with usual home-based rehabilitation | Behavioral: Add-on telerehabilitation and home-based rehabilitation<br>* 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<br>|
| Experimental: Stand-alone usual home-based rehabilitation<br>Stand-alone usual home-based rehabilitation | Behavioral: Home-based rehabilitation alone<br>* 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.<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Rehabilitation, Cardiopulmonary exercise testing