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Clinical Trials/NCT05317975
NCT05317975
Terminated
Not Applicable

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.

National Taiwan University Hospital1 site in 1 country13 target enrollmentJuly 15, 2021
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
National Taiwan University Hospital
Enrollment
13
Locations
1
Primary Endpoint
Change of 6-minute walking test (6MWT) and exercise capacity
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2021
End Date
February 17, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change of 6-minute walking test (6MWT) and exercise capacity

Time Frame: 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 Outcomes

  • Fatigue(The change in BFI 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.)
  • Dyspnea scale(The change in mMRC 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.)
  • Quality of life evaluation(The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.)
  • Grip strength(The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.)

Study Sites (1)

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