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

February 17, 2025 updated by: National Taiwan University Hospital

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. ≥ 20 years of age.
  2. 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:

  1. Unable to cooperate with rehabilitation or evaluation.
  2. Dependent in basic activities of living before infection (Premorbid Barthel index <80).
  3. End stage patient, with life expectancy less than 1 year.
  4. Having contraindications for exercise according to the evaluation of a physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Add-on telerehabilitation combined with usual home-based rehabilitation
Behavioral: Add-on telerehabilitation and home-based rehabilitation
  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
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 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.
The change in mMRC will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Fatigue
Time Frame: 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.
The change in BFI will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Depression and anxiety
Time Frame: 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.
The change in PHQ-9 and GAD-7 will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Cognitive evaluation
Time Frame: 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.
The change in MoCA will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Quality of life evaluation
Time Frame: 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.
The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Grip strength
Time Frame: 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.
The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Hung-Jui Chuang, MD, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Actual)

February 17, 2024

Study Completion (Actual)

February 17, 2025

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202106093RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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