COVID-19NCT06165835
Study on Post-Acute COVID-19 Syndrome in Improvement of COVID-19 Rehabilitated Patients by Respiratory Training
A study testing breathing training in people with COVID-19 and Post-Acute COVID-19 Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Since the emergence of Corona Virus Disease 2019(COVID-19), it has spread rapidly around the world, And it has had a profound impact on the lives and health of people around the world, most of the COVID-19 positive patients are 3-4 weeks after the onset of infection patients can turn negative and recover, however… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Post-Acute COVID-19 Syndrome, Dyspnea
- What is being tested?
- breathing training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2023to 30 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients who have recovered from COVID-19
Who cannot join
- Have suffered from within one year. Those who have recovered from COVID-19 must present proof of diagnosis, such as a medical certificate or screening results, etc., and ICD10 when seeking medical treatment The diagnostic codes are: U07.1 Confirmed COVID-19 virus infection, U09.0 Severe specific infectious pneumonia (COVID-19), unspecified.
- adult, aged 20-90
- conscious mind and behavior normal mental state examination (Mini-Mental State Examination, MMSE) score > 21 points.
- Those who can communicate in verbal or non-verbal ways and understand Chinese and Taiwanese.
- are willing to participate in the research and agree to accept random machine dispatcher
Trial locations and contacts
1 site in 1 country.
About this study
Since the emergence of Corona Virus Disease 2019(COVID-19), it has spread rapidly around the world, And it has had a profound impact on the lives and health of people around the world, most of the COVID-19 positive patients are 3-4 weeks after the onset of infection patients can turn negative and recover, however, increasing observational data suggest that these patients long-term or recurring symptoms such as: fatigue, palpitations, cognitive impairment, dyspnea, anxiety, chest tightness and Pain, etc., symptoms may last at least two months or even longer (for example, up to 12 months), the patient's quality of life and The ability to work and social activities also decline accordingly. Therefore, in addition to the acute symptoms after infection, patients also face the same. The challenge of long-term health sequelae associated with COVID-19.
Read the detailed description
Relevant studies have shown that breathing training can improve the exercise capacity, lung function, and respiratory rate of patients who have recovered from COVID-19. Difficult and other aspects are safe and effective. However, because COVID-19 is an emerging disease, the clinical research literature so far has limited Clinical data are still insufficient, and the effect of respiratory training on the breathing and physical function of COVID-19 patients has not been determined, and most of the patients are not living in the hospital. How to carry out simple and effective breathing training to reduce the long-term impact of COVID-19 on patients is worthy of continuous discussion. This study will assist COVID-19 patients to perform respiratory training with incentive spirometer intervention, and collect patients before and after the intervention Oxygen requirements, blood draw values and Post-COVID-19 Functional Status scale(PCFS scale) and other data to explore and evaluate the effect of interventional breathing training on the improvement of symptoms of new coronary pneumonia, as a reference for future clinical treatment and improvement of symptoms of COVID-19.
- Conditions
- COVID-19, Post-Acute COVID-19 Syndrome, Dyspnea, Incentive Spirometer
- Being tested
- breathing training
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing trainingDevice
Also called Incentive Spirometer
Breathing training for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | No intervention | Patients who have recovered from COVID-19 |
| Three months after recovering from COVID-19 | Experimental | Patients who have from COVID-19 in three months Receives: Device: breathing training |
| Six months after recovering from COVID-19 | Experimental | Patients who have from COVID-19 in three to six months Receives: Device: breathing training |
| Nine months after recovering from COVID-19 | Experimental | Patients who have from COVID-19 in six to nine months Receives: Device: breathing training |
| Twelve months after recovering from COVID-19 | Experimental | Patients who have from COVID-19 in nine to twelve months Receives: Device: breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen requirements, blood draw values
Oxygen requirements, blood draw values
Measured: 6 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jul 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen, Yao-Hsiang, Tri-Service General Hospital (TSGH)
- Investigators
- Yao-Hsiang Chen, Principal investigator, Tri Service General Hospital Sonshan Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165835
- Sponsor's protocol ID
- A202305044
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen YH, Lin CH, Liu JH, Lin HA, Hsieh YS. Effects of incentive spirometer training on dyspnea and functional status in patients with long COVID. PLoS One. 2026 Jun 22;21(6):e0351553. doi: 10.1371/journal.pone.0351553. eCollection 2026.
PubMed 42330008
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Post-Acute COVID-19 Syndrome in Improvement of COVID-19 Rehabilitated Patients by Respiratory Training
- ClinicalTrials.gov ID
- NCT06165835
- Acronym / sponsor ID
- A202305044
- Conditions
- COVID-19, Post-Acute COVID-19 Syndrome, Dyspnea, Incentive Spirometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Dec 2023 (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.
Since the emergence of Corona Virus Disease 2019(COVID-19), it has spread rapidly around the world, And it has had a profound impact on the lives and health of people around the world, most of the COVID-19 positive patients are 3-4 weeks after the onset of infection patients can turn negative and recover, however, increasing observational data suggest that these patients long-term or recurring symptoms such as: fatigue, palpitations, cognitive impairment, dyspnea, anxiety, chest tightness and Pain, etc., symptoms may last at least two months or even longer (for example, up to 12 months), the patient's quality of life and The ability to work and social activities also decline accordingly. Therefore, in addition to the acute symptoms after infection, patients also face the same. The challenge of long-term health sequelae associated with COVID-19.
Detailed description
Relevant studies have shown that breathing training can improve the exercise capacity, lung function, and respiratory rate of patients who have recovered from COVID-19. Difficult and other aspects are safe and effective. However, because COVID-19 is an emerging disease, the clinical research literature so far has limited Clinical data are still insufficient, and the effect of respiratory training on the breathing and physical function of COVID-19 patients has not been determined, and most of the patients are not living in the hospital. How to carry out simple and effective breathing training to reduce the long-term impact of COVID-19 on patients is worthy of continuous discussion. This study will assist COVID-19 patients to perform respiratory training with incentive spirometer intervention, and collect patients before and after the intervention Oxygen requirements, blood draw values and Post-COVID-19 Functional Status scale(PCFS scale) and other data to explore and evaluate the effect of interventional breathing training on the improvement of symptoms of new coronary pneumonia, as a reference for future clinical treatment and improvement of symptoms of COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental | No intervention | –Patients who have recovered from COVID-19 |
| Three months after recovering from COVID-19 | Experimental | Device: breathing trainingPatients who have from COVID-19 in three months |
| Six months after recovering from COVID-19 | Experimental | Device: breathing trainingPatients who have from COVID-19 in three to six months |
| Nine months after recovering from COVID-19 | Experimental | Device: breathing trainingPatients who have from COVID-19 in six to nine months |
| Twelve months after recovering from COVID-19 | Experimental | Device: breathing trainingPatients who have from COVID-19 in nine to twelve months |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients who have recovered from COVID-19
Key exclusion criteria (5 listed)
- Have suffered from within one year. Those who have recovered from COVID-19 must present proof of diagnosis, such as a medical certificate or screening results, etc., and ICD10 when seeking medical treatment The diagnostic codes are: U07.1 Confirmed COVID-19 virus infection, U09.0 Severe specific infectious pneumonia (COVID-19), unspecified.
- adult, aged 20-90
- conscious mind and behavior normal mental state examination (Mini-Mental State Examination, MMSE) score > 21 points.
- Those who can communicate in verbal or non-verbal ways and understand Chinese and Taiwanese.
- are willing to participate in the research and agree to accept random machine dispatcher
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 |
|---|---|---|
| breathing trainingAlso: Incentive SpirometerBreathing training for six weeks. | Device | Nine months after recovering from COVID-19, Six months after recovering from COVID-19, Three months after recovering from COVID-19, Twelve months after recovering from COVID-19 |
Primary outcome
Oxygen requirements, blood draw values
Time frame: 6 WEEKS
Oxygen requirements, blood draw values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 42330008Chen YH, Lin CH, Liu JH, Lin HA, Hsieh YS. Effects of incentive spirometer training on dyspnea and functional status in patients with long COVID. PLoS One. 2026 Jun 22;21(6):e0351553. doi: 10.1371/journal.pone.0351553. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
Yao-Hsiang Chen principal investigator
Tri Service General Hospital Sonshan Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breathing training in people with COVID-19 and Post-Acute COVID-19 Syndrome, run by Tri-Service General Hospital (TSGH) 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 3 Apr 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxygen requirements, blood draw values (time frame: 6 WEEKS). 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 NCT06165835, which also lists 1 linked publication.
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 3 Apr 2025.