Clinical trial NCT05317975: 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
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Rehabilitation
Cardiopulmonary exercise testing
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of 6-minute walking test (6MWT) and exercise capacity
timeFrame: The change in 6MWT and peak oxygen uptake will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Secondary outcomes:
measure: Dyspnea scale
timeFrame: The change in mMRC will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
measure: Fatigue
timeFrame: The change in BFI will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
measure: Depression and anxiety
timeFrame: The change in PHQ-9 and GAD-7 will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
measure: Cognitive evaluation
timeFrame: The change in MoCA will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
measure: Quality of life evaluation
timeFrame: The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
measure: Grip strength
timeFrame: The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
name: Hung-Jui Chuang, MD
role: PRINCIPAL_INVESTIGATOR
References: