COVID-19NCT05317975
The Effect of Home-based Rehabilitation Program After COVID-19 Infection
A study testing Add-on telerehabilitation and home-based rehabilitation and Home-based rehabilitation alone in people with COVID-19, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Add-on telerehabilitation and home-based rehabilitation and Home-based rehabilitation alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2021to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Add-on telerehabilitation and home-based rehabilitation, Home-based rehabilitation alone
- Keywords
- COVID-19, Rehabilitation, Cardiopulmonary exercise testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Add-on telerehabilitation and home-based rehabilitationBehavioural
- 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 aloneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Add-on telerehabilitation combined with usual home-based rehabilitation | Experimental | Add-on telerehabilitation combined with usual home-based rehabilitation Receives: Behavioral: Add-on telerehabilitation and home-based rehabilitation |
| Stand-alone usual home-based rehabilitation | Experimental | Stand-alone usual home-based rehabilitation Receives: Behavioral: Home-based rehabilitation alone |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The change in 6MWT and peak oxygen uptake will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Secondary outcomes (6)
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.
Measured: The change in mMRC will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
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.
Measured: The change in BFI will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
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.
Measured: The change in PHQ-9 and GAD-7 will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
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.
Measured: The change in MoCA will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Quality of life evaluation
The investigators will assess the change in EuroQol-5D.
Measured: The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Grip strength
The investigators will assess the grip strength using a grip goniometer with the participants seated and the elbow flexed at 90 degree.
Measured: The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start15 Jul 2021
- Primary completion17 Feb 2024
- Study completion17 Feb 2025
Why it stopped: Recruitment difficulties and insufficient funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Jui Chuang, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317975
- Sponsor's protocol ID
- 202106093RIND
- Status last verified
- Feb 2025
- First submitted
- 31 Mar 2022
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05317975
- Acronym / sponsor ID
- 202106093RIND
- Conditions
- COVID-19
- Keywords
- COVID-19, Rehabilitation, Cardiopulmonary exercise testing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties and insufficient funding.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Add-on telerehabilitation combined with usual home-based rehabilitation | Experimental | Behavioral: Add-on telerehabilitation and home-based rehabilitationAdd-on telerehabilitation combined with usual home-based rehabilitation |
| Stand-alone usual home-based rehabilitation | Experimental | Behavioral: Home-based rehabilitation aloneStand-alone usual home-based rehabilitation |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Add-on telerehabilitation and home-based rehabilitation1. 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 | Behavioural | Add-on telerehabilitation combined with usual home-based rehabilitation |
| Home-based rehabilitation alone12wk 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. | Behavioural | Stand-alone usual home-based rehabilitation |
Primary outcome
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.
6 secondary outcomes
Dyspnea scale
Time frame: 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.
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.
Cognitive evaluation
Time frame: 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.
Grip strength
Time frame: The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.
Results and safety
The study was stopped early (reason given: Recruitment difficulties and insufficient funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Jui Chuang, MD principal investigator
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Add-on telerehabilitation and home-based rehabilitation and Home-based rehabilitation alone in people with COVID-19, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties and insufficient funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.