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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Add-on telerehabilitation and home-based rehabilitation
Home-based rehabilitation alone
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Rehabilitation, Cardiopulmonary exercise testing

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Add-on telerehabilitation combined with usual home-based rehabilitation

Stand-alone usual home-based rehabilitation

Usual care

Arm Description

Add-on telerehabilitation combined with usual home-based rehabilitation

Stand-alone usual home-based rehabilitation

Usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Quality of life evaluation
The investigators will assess the change in EuroQol-5D.
Grip strength
The investigators will assess the grip strength using a grip goniometer with the participants seated and the elbow flexed at 90 degree.

Full Information

First Posted
March 31, 2022
Last Updated
April 7, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05317975
Brief Title
The Effect of Home-based Rehabilitation Program After COVID-19 Infection
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Rehabilitation, Cardiopulmonary exercise testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Add-on telerehabilitation combined with usual home-based rehabilitation
Arm Type
Experimental
Arm Description
Add-on telerehabilitation combined with usual home-based rehabilitation
Arm Title
Stand-alone usual home-based rehabilitation
Arm Type
Experimental
Arm Description
Stand-alone usual home-based rehabilitation
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Add-on telerehabilitation and home-based rehabilitation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Home-based rehabilitation alone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of 6-minute walking test (6MWT) and exercise capacity
Description
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.
Time Frame
The change in 6MWT and peak oxygen uptake will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Secondary Outcome Measure Information:
Title
Dyspnea scale
Description
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.
Time Frame
The change in mMRC will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Title
Fatigue
Description
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.
Time Frame
The change in BFI will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Title
Depression and anxiety
Description
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.
Time Frame
The change in PHQ-9 and GAD-7 will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Title
Cognitive evaluation
Description
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.
Time Frame
The change in MoCA will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Title
Quality of life evaluation
Description
The investigators will assess the change in EuroQol-5D.
Time Frame
The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Title
Grip strength
Description
The investigators will assess the grip strength using a grip goniometer with the participants seated and the elbow flexed at 90 degree.
Time Frame
The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huey-Wen Liang, MD-PHD
Phone
00886-2-23123456
Ext
66697
Email
lianghw@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Jui Chuang, MD
Phone
00886-2-23123456
Ext
67034
Email
rexintwo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Jui Chuang, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Jui Chuang, MD
Phone
00886-2-23123456
Ext
67034
Email
Rexintwo@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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