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

Not Applicable

Recruiting

• Conditions: COVID-19
• Interventions: Behavioral: Home-based rehabilitation alone; Behavioral: Add-on telerehabilitation and home-based rehabilitation

• Registration Number: NCT05317975
• Lead Sponsor: National Taiwan University Hospital

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-15
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-14
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stand-alone usual home-based rehabilitation	Home-based rehabilitation alone	Stand-alone usual home-based rehabilitation
Add-on telerehabilitation combined with usual home-based rehabilitation	Add-on telerehabilitation and home-based rehabilitation	Add-on telerehabilitation combined with usual home-based rehabilitation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan