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

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317975
• Other study ID #: 202106093RIND
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: Huey-Wen Liang, MD-PHD
• Phone: 00886-2-23123456
• Email: lianghw[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Add-on telerehabilitation and home-based rehabilitation
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
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.