Post Acute COVID-19 SyndromeCOVID-19NCT05539950
Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome
A study testing Cardiopulmonary rehabilitation and Health education in people with Post Acute COVID-19 Syndrome, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
In 2022, though the optimized acute medical treatment of COVID-19 was determined, patients often experience the sequelae (also known as post-acute COVID-19 syndrome, the patients might develop cough, breathlessness, fatigue, weakness, impaired activities of daily livings etc.). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Post Acute COVID-19 Syndrome
- What is being tested?
- Cardiopulmonary rehabilitation and Health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2022to 31 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be willing and able to provide written informed consent and comply with all procedures required by the protocol
- be 20 - 80 years of age at the time of signing the Informed Consent Form
- diagnosed with COVID-19 with PCR and admitted with at least moderate COVID-19 disease (with clinical symptoms or imaging evidence of low respiratory tract involvement)
- diagnosed with COVID-19 for over 4 weeks but less than 2 years with fatigue, shortness of breath, cough, weakness, or impairments of activities of daily life
- able to cooperate with the rehabilitation programs and cycling
Who cannot join
- Patients under 20-year-old or over 80-year-old, pregnant, prisoners
- Patients without national health insurance in Taiwan
- The patient cannot follow instructions or cycling
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
Taipei, 235
About this study
In 2022, though the optimized acute medical treatment of COVID-19 was determined, patients often experience the sequelae (also known as post-acute COVID-19 syndrome, the patients might develop cough, breathlessness, fatigue, weakness, impaired activities of daily livings etc.). Until now, there is no consensus for post-acute COVID-19 syndrome management. Previously, the cardiopulmonary rehabilitation revealed significant benefits in heart failure or chronic obstructive pulmonary disease. The aims of the study are demonstrating the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.
Read the detailed description
PURPOSE: To demonstrate the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.
METHODS: The participants will be divided into two groups: one with cardiopulmonary rehabilitations programs under the supervision of therapists 3 times a week, 12 weeks in total with lifestyle modification (experimental group); and the other with lifestyle modification and health education (active-controlled group). Before and after the interventions, several endpoints in interested are performed by the physicians or the research assistants, including cardiopulmonary exercise training (CPET), 6-minute-walk-test (6MWT), pulmonary function tests (PFT), and quality of life (QoL, we plan to use SF-36) questionnaire.
- Conditions
- Post Acute COVID-19 Syndrome
- Being tested
- Cardiopulmonary rehabilitation, Health education
- Keywords
- Long COVID, Cardiopulmonary rehabilitation
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary rehabilitationOther
Cardiopulmonary rehabilitation helps patients maximize functional potential due to progressive deconditioning or acute decompensation following an acute medical event. This intervention is medically supervised and individualized according to their results of the cardiopulmonary Exercise Testing (CPET).
Health educationOther
Individualized exercise prescription will be given according to their results of the cardiopulmonary Exercise Testing (CPET). Recommendations for lifestyle modification will also be given.
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary rehabilitation with health education | Experimental | The participants will participate in cardiopulmonary rehabilitations programs under the supervision of therapists 3 times a week, 12 weeks in total. Recommendations for individualized exercise prescription and lifestyle modification will be given to the participants as well. Receives: Other: Cardiopulmonary rehabilitation; Other: Health education |
| Health education | Active comparator | The participants will be given recommendations for individualized exercise prescription and lifestyle modification. Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cardiopulmonary exercise testing (CPET)
CPET is a non-invasive examination, which provides assessment of the integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems. It permits the evaluation of both submaximal and peak exercise responses. CPET is currently act as a clinical applications for the evaluation of undiagnosed exercise intolerance and for the objective determination of functional capacity and impairment.
Measured: Baseline, Week 12
Secondary outcomes (3)
Changes in 6 minutes walking test (6MWT)
6MWT is a commonly used test for the objective assessment of functional exercise capacity for the management of patients with moderate-to-severe pulmonary disease. This test does not require complex equipment or technical expertise. The participant is asked to walk as far as possible along a 30-m minimally trafficked corridor for a period of 6 min with the primary outcome measure being the 6-min walk distance (6MWD) measured in meters.
Measured: Baseline, Week 12
Changes in Pulmonary function test (PFT)
PFT is used in investigating and monitoring of patients with respiratory pathology. PFT allows physicians to quantify the severity of the pulmonary disease, follow it up over time, and assess its response to treatment.
Measured: Baseline, Week 12
Changes in 36-Item Short Form Survey (SF-36)
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. This questionnaire includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Unable to get funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Chou Chen, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539950
- Sponsor's protocol ID
- TMU-IJRB-N202208050
- Acronym
- COVID-19
- Status last verified
- Mar 2025
- First submitted
- 12 Sep 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albouaini K, Egred M, Alahmar A, Wright DJ. Cardiopulmonary exercise testing and its application. Postgrad Med J. 2007 Nov;83(985):675-82. doi: 10.1136/hrt.2007.121558.
PubMed 17989266Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.
PubMed 31689414Ponce MC, Sharma S. Pulmonary Function Tests. [Updated 2021 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482339/
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT05539950
- Acronym / sponsor ID
- COVID-19 / TMU-IJRB-N202208050
- Conditions
- Post Acute COVID-19 Syndrome
- Keywords
- Long COVID, Cardiopulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to get funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Sep 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.
In 2022, though the optimized acute medical treatment of COVID-19 was determined, patients often experience the sequelae (also known as post-acute COVID-19 syndrome, the patients might develop cough, breathlessness, fatigue, weakness, impaired activities of daily livings etc.). Until now, there is no consensus for post-acute COVID-19 syndrome management. Previously, the cardiopulmonary rehabilitation revealed significant benefits in heart failure or chronic obstructive pulmonary disease. The aims of the study are demonstrating the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.
Detailed description
PURPOSE: To demonstrate the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.
METHODS: The participants will be divided into two groups: one with cardiopulmonary rehabilitations programs under the supervision of therapists 3 times a week, 12 weeks in total with lifestyle modification (experimental group); and the other with lifestyle modification and health education (active-controlled group). Before and after the interventions, several endpoints in interested are performed by the physicians or the research assistants, including cardiopulmonary exercise training (CPET), 6-minute-walk-test (6MWT), pulmonary function tests (PFT), and quality of life (QoL, we plan to use SF-36) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary rehabilitation with health education | Experimental | Other: Cardiopulmonary rehabilitation, Other: Health educationThe participants will participate in cardiopulmonary rehabilitations programs under the supervision of therapists 3 times a week, 12 weeks in total. Recommendations for individualized exercise prescription and lifestyle modification will be given to the participants as well. |
| Health education | Active comparator | Other: Health educationThe participants will be given recommendations for individualized exercise prescription and lifestyle modification. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be willing and able to provide written informed consent and comply with all procedures required by the protocol
- be 20 - 80 years of age at the time of signing the Informed Consent Form
- diagnosed with COVID-19 with PCR and admitted with at least moderate COVID-19 disease (with clinical symptoms or imaging evidence of low respiratory tract involvement)
- diagnosed with COVID-19 for over 4 weeks but less than 2 years with fatigue, shortness of breath, cough, weakness, or impairments of activities of daily life
- able to cooperate with the rehabilitation programs and cycling
Key exclusion criteria (3 listed)
- Patients under 20-year-old or over 80-year-old, pregnant, prisoners
- Patients without national health insurance in Taiwan
- The patient cannot follow instructions or cycling
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 |
|---|---|---|
| Cardiopulmonary rehabilitationCardiopulmonary rehabilitation helps patients maximize functional potential due to progressive deconditioning or acute decompensation following an acute medical event. This intervention is medically supervised and individualized according to their results of the cardiopulmonary Exercise Testing (CPET). | Other | Cardiopulmonary rehabilitation with health education |
| Health educationIndividualized exercise prescription will be given according to their results of the cardiopulmonary Exercise Testing (CPET). Recommendations for lifestyle modification will also be given. | Other | Cardiopulmonary rehabilitation with health education, Health education |
Primary outcome
Changes in Cardiopulmonary exercise testing (CPET)
Time frame: Baseline, Week 12
CPET is a non-invasive examination, which provides assessment of the integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems. It permits the evaluation of both submaximal and peak exercise responses. CPET is currently act as a clinical applications for the evaluation of undiagnosed exercise intolerance and for the objective determination of functional capacity and impairment.
3 secondary outcomes
Changes in 6 minutes walking test (6MWT)
Time frame: Baseline, Week 12
Changes in Pulmonary function test (PFT)
Time frame: Baseline, Week 12
Changes in 36-Item Short Form Survey (SF-36)
Time frame: Baseline, Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Background: PubMed 17989266Albouaini K, Egred M, Alahmar A, Wright DJ. Cardiopulmonary exercise testing and its application. Postgrad Med J. 2007 Nov;83(985):675-82. doi: 10.1136/hrt.2007.121558.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 31689414Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.
- BackgroundPonce MC, Sharma S. Pulmonary Function Tests. [Updated 2021 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482339/
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary rehabilitation and Health education in people with Post Acute COVID-19 Syndrome, run by Taipei Medical University Shuang Ho 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Mar 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 withdrawn before enrolling participants, so there are no results.
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?
Changes in Cardiopulmonary exercise testing (CPET) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05539950, which also lists 4 linked publications.
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 26 Mar 2025.