COVID-19
Conditions
Keywords
COVID-19, Rehabilitation, Cardiopulmonary exercise testing
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.
Interventions
BEHAVIORALAdd-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
BEHAVIORALHome-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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Taiwan
Outcome results
None listed