COVID-19 PandemicNCT06231225
Study on the Effect of Incentive Spirometer-based Respiratory Training on the Long COVID-19
A study testing Incentive Spirometer respiratory training in people with COVID-19 Pandemic and Diabetes, run by National Taipei University of Nursing and Health Sciences.
Trial summary
The COVID-19 pandemic has emerged as the most significant public health crisis of the 21st century. As of the end of January 2023, global confirmed cases have exceeded 670 million, with a domestic cumulative total of 10.24 million cases, including occurrences of reinfection. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- COVID-19 Pandemic, Diabetes, Hypertension
- What is being tested?
- Incentive Spirometer respiratory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Aug 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who have contracted and recovered from COVID-19 within the past year must present proof of diagnosis, such as medical certificates or screening results. The ICD-10 diagnosis codes are: U07.1 for confirmed COVID-19 viral infection, and U09.0 for post-COVID-19 condition, unspecified. Recovery is defined as testing negative in a COVID-19 rapid test.
- Never diagnosed with hypertensive diseases (ICD-10 codes: I10.x or I11.x), diabetes (ICD-10 codes: E10.x or E11.x), or heart diseases (ICD-10 codes: I25.x, I50.x, I65.x, or I67.x and classified as Class I or II by the New York Heart Association functional classification).
- Exhibiting long-term respiratory symptoms related to COVID-19, such as post-exertional breathlessness, chest discomfort, cough, difficulty breathing, rapid breathing, etc., and meeting at least one of these criteria for inclusion.
- Aged between 20 - 90 years.
- Able to communicate in and understand Mandarin or Taiwanese, either verbally or non-verbally.
- Willing to participate in the study and agree to be assigned.
Who cannot join
- Patients with a functional status classified as level 5 or higher on the Modified Rankin Scale (MRS), indicating severe disability and bedridden status.
- Patients suffering from dementia, such as Alzheimer's, Parkinson's disease, etc.
- Patients with acute psychiatric symptoms who are unable to communicate.
- Individuals with a high risk of litigation.
- Patients suffering from Chronic Obstructive Pulmonary Disease (COPD) or any other respiratory system diseases.
- Patients with moderate or severe heart disease, classified as Class III or IV by the New York Heart Association functional classification.
- -
About this study
Official title: Study on the Effect of Incentive Spirometer-based Respiratory Training on the Long COVID-19 Symptoms in Chronic Disease Patients After Recovery From COVID-19
The COVID-19 pandemic has emerged as the most significant public health crisis of the 21st century. As of the end of January 2023, global confirmed cases have exceeded 670 million, with a domestic cumulative total of 10.24 million cases, including occurrences of reinfection. Beyond acute symptoms following infection, patients and society face the challenge of long-term complications associated with COVID-19. Termed 'Post COVID-19 condition' or 'Long COVID' by the World Health Organization (WHO), this encompasses symptoms appearing within three months of the initial infection. Symptoms of Long COVID reveal chronic damage inflicted by the virus on multiple organ systems, including fatigue, cognitive impairment, chest tightness, palpitations, difficulty breathing, and depression.
Despite continuous efforts by healthcare professionals to find suitable treatments, no medication has been confirmed to effectively prevent or reduce post-COVID-19 sequelae. These health issues impose significant burdens and disturbances on patients' quality of life, economies, and societies.
Read the detailed description
According to the Ministry of Health and Welfare's report on the top 10 causes of death in the 111th year, aside from the marked increase in COVID-19 cases, there have been significant increases in hypertensive diseases, Cardiac diseases, and diabetes .Therefore, addressing the post-COVID-19 sequelae among chronic disease patients is an essential global health issue in the post-pandemic era.
Current research indicates that respiratory training is safe and effective in improving the exercise capacity, lung function, and alleviating respiratory difficulties in COVID-19 recovered patients. The impact of respiratory training on patients' respiratory and physical function remains uncertain, especially considering that many present-day infections are among non-hospitalized individuals with mild symptoms. Thus, exploring simple and effective respiratory training methods to reduce COVID-19's long-term impact on patients warrants continuous investigation.
Therefore, this study will employ Incentive spirometer-based respiratory training to assist COVID-19 patients who has diabetes, hypertensive disease, or cardiac disease in respiratory training. Data collection before and after the intervention will involve oxygen demand, blood parameters, the post-COVID-19 Functional Status scale (PCFS scale), and lung function indices, to investigate and evaluate the effectiveness of intervention respiratory training in improving Long COVID symptoms.
- Conditions
- COVID-19 Pandemic, Diabetes, Hypertension, Cardiac Disease, Long COVID
- Being tested
- Incentive Spirometer respiratory training
- Keywords
- COVID-19, Post-Acute COVID-19 Syndrome, Long COVID-19, respiratory training, Hypertensive diseases, Cardiac diseases, Diabetes, Dyspnea, Incentive Spirometer
- Medical subject headings
- COVID-19, Diabetes Mellitus, Hypertension, Heart Diseases, 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.
Incentive Spirometer respiratory trainingBehavioural
The incentive spirometer is a handheld mechanical breathing device that uses a one-way valve to prevent exhalation. It consists of a corrugated tube and a nozzle connected to three consecutive plastic chambers, each containing a ball. The external chambers are marked with the minimum flow required to raise the ball internally. The ball rises when the patient performs slow, deep breathing through the nozzle. If the patient breathes too quickly, the balls in the chambers rise to the top, and if breathing is too slow, the balls fall to the bottom. The number of increasing balls measures the volume of inhaled air. When all three balls reach the top of the chambers, the patient's flow rate can reach 1200 ml/s. After the patient has maximized their inhalation, they are asked to hold the balls in the same position for more than 3 sec.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | not assign respiratory training |
| treatment group | Experimental | assign respiratory training Receives: Behavioral: Incentive Spirometer respiratory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-COVID-19 Functional Status scale
for check the effect of respiratory training
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Lung function indices
for check the effect of respiratory training
Measured: through study completion, an average of 1 year
Hemoglobin and oxygen levels
for check the effect of respiratory training
Measured: through study completion, an average of 1 year
Six-minute walk test (6MWT)
for check the effect of respiratory training
Measured: through study completion, an average of 1 year
Dyspnoea-12 (D-12) scale
for check the effect of respiratory training
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Principal investigator, Yu-Shan Hsieh, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231225
- Sponsor's protocol ID
- B202305165
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2024
- Last updated
- 30 Jan 2024
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Incentive Spirometer-based Respiratory Training on the Long COVID-19 Symptoms in Chronic Disease Patients After Recovery From COVID-19
- ClinicalTrials.gov ID
- NCT06231225
- Acronym / sponsor ID
- B202305165
- Conditions
- COVID-19 Pandemic, Diabetes, Hypertension, Cardiac Disease, Long COVID
- Keywords
- COVID-19, Post-Acute COVID-19 Syndrome, Long COVID-19, respiratory training, Hypertensive diseases, Cardiac diseases, Diabetes, Dyspnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 30 Jan 2024 (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.
The COVID-19 pandemic has emerged as the most significant public health crisis of the 21st century. As of the end of January 2023, global confirmed cases have exceeded 670 million, with a domestic cumulative total of 10.24 million cases, including occurrences of reinfection. Beyond acute symptoms following infection, patients and society face the challenge of long-term complications associated with COVID-19. Termed 'Post COVID-19 condition' or 'Long COVID' by the World Health Organization (WHO), this encompasses symptoms appearing within three months of the initial infection. Symptoms of Long COVID reveal chronic damage inflicted by the virus on multiple organ systems, including fatigue, cognitive impairment, chest tightness, palpitations, difficulty breathing, and depression.
Despite continuous efforts by healthcare professionals to find suitable treatments, no medication has been confirmed to effectively prevent or reduce post-COVID-19 sequelae. These health issues impose significant burdens and disturbances on patients' quality of life, economies, and societies.
Detailed description
According to the Ministry of Health and Welfare's report on the top 10 causes of death in the 111th year, aside from the marked increase in COVID-19 cases, there have been significant increases in hypertensive diseases, Cardiac diseases, and diabetes .Therefore, addressing the post-COVID-19 sequelae among chronic disease patients is an essential global health issue in the post-pandemic era.
Current research indicates that respiratory training is safe and effective in improving the exercise capacity, lung function, and alleviating respiratory difficulties in COVID-19 recovered patients. The impact of respiratory training on patients' respiratory and physical function remains uncertain, especially considering that many present-day infections are among non-hospitalized individuals with mild symptoms. Thus, exploring simple and effective respiratory training methods to reduce COVID-19's long-term impact on patients warrants continuous investigation.
Therefore, this study will employ Incentive spirometer-based respiratory training to assist COVID-19 patients who has diabetes, hypertensive disease, or cardiac disease in respiratory training. Data collection before and after the intervention will involve oxygen demand, blood parameters, the post-COVID-19 Functional Status scale (PCFS scale), and lung function indices, to investigate and evaluate the effectiveness of intervention respiratory training in improving Long COVID symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –not assign respiratory training |
| treatment group | Experimental | Behavioral: Incentive Spirometer respiratory trainingassign respiratory training |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals who have contracted and recovered from COVID-19 within the past year must present proof of diagnosis, such as medical certificates or screening results. The ICD-10 diagnosis codes are: U07.1 for confirmed COVID-19 viral infection, and U09.0 for post-COVID-19 condition, unspecified. Recovery is defined as testing negative in a COVID-19 rapid test.
- Never diagnosed with hypertensive diseases (ICD-10 codes: I10.x or I11.x), diabetes (ICD-10 codes: E10.x or E11.x), or heart diseases (ICD-10 codes: I25.x, I50.x, I65.x, or I67.x and classified as Class I or II by the New York Heart Association functional classification).
- Exhibiting long-term respiratory symptoms related to COVID-19, such as post-exertional breathlessness, chest discomfort, cough, difficulty breathing, rapid breathing, etc., and meeting at least one of these criteria for inclusion.
- Aged between 20 - 90 years.
- Able to communicate in and understand Mandarin or Taiwanese, either verbally or non-verbally.
Key exclusion criteria (7 listed)
- Patients with a functional status classified as level 5 or higher on the Modified Rankin Scale (MRS), indicating severe disability and bedridden status.
- Patients suffering from dementia, such as Alzheimer's, Parkinson's disease, etc.
- Patients with acute psychiatric symptoms who are unable to communicate.
- Individuals with a high risk of litigation.
- Patients suffering from Chronic Obstructive Pulmonary Disease (COPD) or any other respiratory system diseases.
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 |
|---|---|---|
| Incentive Spirometer respiratory trainingThe incentive spirometer is a handheld mechanical breathing device that uses a one-way valve to prevent exhalation. It consists of a corrugated tube and a nozzle connected to three consecutive plastic chambers, each containing a ball. The external chambers are marked with the minimum flow required to raise the ball internally. The ball rises when the patient performs slow, deep breathing through the nozzle. If the patient breathes too quickly, the balls in the chambers rise to the top, and if breathing is too slow, the balls fall to the bottom. The number of increasing balls measures the volume of inhaled air. When all three balls reach the top of the chambers, the patient's flow rate can reach 1200 ml/s. After the patient has maximized their inhalation, they are asked to hold the balls in the same position for more than 3 sec. | Behavioural | treatment group |
Primary outcome
Post-COVID-19 Functional Status scale
Time frame: through study completion, an average of 1 year
for check the effect of respiratory training
4 secondary outcomes
Lung function indices
Time frame: through study completion, an average of 1 year
Hemoglobin and oxygen levels
Time frame: through study completion, an average of 1 year
Six-minute walk test (6MWT)
Time frame: through study completion, an average of 1 year
Dyspnoea-12 (D-12) scale
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive Spirometer respiratory training in people with COVID-19 Pandemic and Diabetes, run by National Taipei University of Nursing and Health Sciences.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Post-COVID-19 Functional Status scale (time frame: through study completion, an average of 1 year). 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 30 Jan 2024.