Long COVIDNCT06379672
Resonance Breathing Training for Long Covid-related Myocardial Injury
A study testing Resonance breathing in people with Long COVID and Myocardial Injury, run by Chengdu Sport University.
Trial summary
An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Long COVID, Myocardial Injury
- What is being tested?
- Resonance breathing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2024to 5 Oct 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years;
- According to the WHO definition: one or more systemic involvement present 3 months after the diagnosis of a new crown infection, and at least 2 of these months cannot be explained by other diseases
- 2D-STE suggestive of GLSAVG: -17% ≤ men ≤ -10%, -18% ≤ women ≤ -10%;
- Consent for enrollment based on the degree of myocardial injury, as diagnosed by a clinician;
- Signing the informed consent form with the consent of the patient or his/her family members
Who cannot join
- (1) Previous history of coronary atherosclerotic heart disease and heart failure; (2) Combination of severe arrhythmia or cardiogenic shock; (3) Combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or higher grade, acute myocarditis or pericarditis; (4) Combination of any disease that severely affects limb movement, such as musculoskeletal system disease or severe hepatic or renal insufficiency; (5) Combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc; Those who have serious mental illness and are unable to cooperate
Trial locations and contacts
No sites are listed yet.
Rui Li contact
About this study
Official title: An Investigation of the Efficacy of Resonance Breathing Training in the Rehabilitation of Patients with Long Covid-related Myocardial Injury
An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury
- Conditions
- Long COVID, Myocardial Injury
- Being tested
- Resonance breathing
- Keywords
- 2D-STE, resonance breathing, Myocardial Injury, Long Covid-19
- 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.
Resonance breathingOther
Resonant breathing was used on the subjects, using nasal inhalation and oral exhalation, for a total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Subjects were asked to remain in a standing position with their feet shoulder-width apart. The right hand was placed on the chest and the left hand on the abdomen. Inhale to make the abdomen bulge and exhale to make the abdomen sink (inhale through the nose and exhale through the mouth). This was done 2 times a day, once in the morning and once in the afternoon. Complete 3 sets of 8 breaths each. Each breath lasts 10 seconds (4 seconds inhaling and 6 seconds exhaling). Receives: Other: Resonance breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
New YorkHeart Association (NYHA)
The scale is divided into four levels
Grade 1 is unrestricted activity. Daily physical activity does not cause significant shortness of breath, fatigue or palpitations Grade 2 is a mild limitation of activity. Asymptomatic at rest, daily activities may cause significant shortness of breath, fatigue or palpitations Grade 3 is marked limitation of activity. May be asymptomatic at rest, but may cause significant shortness of breath, fatigue, or palpitations with less than daily activity.
Grade 4 is symptomatic at rest, with discomfort associated with any physical activity. Class IVa for those who can move around indoors or at the bedside without intravenous drug administration; Class IVb for those who cannot get out of bed and require intravenous drug administration.
Measured: 12weeks
left ventricle global longitudinal strain, LVGLS
The magnitude of overall longitudinal myocardial strain in the left ventricle on two-dimensional speckle tracking echocardiograms as an average of the peak longitudinal strain in all myocardial segments. The normal range is (-25% to -17%) in men and (-25% to -18%) in women.
Measured: 12weeks
Secondary outcomes (2)
hypertension
Blood pressure included both systolic and diastolic blood pressure and was observed before and after the intervention for any reduction in blood pressure.
Measured: 12weeks
Average heart rate
One-minute average heart rate (at rest).
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start25 Aug 2024 (estimated)
- Primary completion25 Sep 2024 (estimated)
- Study completion5 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Yang, Chengdu Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379672
- Sponsor's protocol ID
- 2023[No.193]
- Status last verified
- Jul 2024
- First submitted
- 18 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Efficacy of Resonance Breathing Training in the Rehabilitation of Patients with Long Covid-related Myocardial Injury
- ClinicalTrials.gov ID
- NCT06379672
- Acronym / sponsor ID
- 2023[No.193]
- Conditions
- Long COVID, Myocardial Injury
- Keywords
- 2D-STE, resonance breathing, Myocardial Injury, Long Covid-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chengdu Sport UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (estimated)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 5 Oct 2024 (estimated)
- First posted
- 23 Apr 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.
An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Resonance breathingSubjects were asked to remain in a standing position with their feet shoulder-width apart. The right hand was placed on the chest and the left hand on the abdomen. Inhale to make the abdomen bulge and exhale to make the abdomen sink (inhale through the nose and exhale through the mouth). This was done 2 times a day, once in the morning and once in the afternoon. Complete 3 sets of 8 breaths each. Each breath lasts 10 seconds (4 seconds inhaling and 6 seconds exhaling). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 60 years;
- According to the WHO definition: one or more systemic involvement present 3 months after the diagnosis of a new crown infection, and at least 2 of these months cannot be explained by other diseases
- 2D-STE suggestive of GLSAVG: -17% ≤ men ≤ -10%, -18% ≤ women ≤ -10%;
- Consent for enrollment based on the degree of myocardial injury, as diagnosed by a clinician;
- Signing the informed consent form with the consent of the patient or his/her family members
Key exclusion criteria (1 listed)
- (1) Previous history of coronary atherosclerotic heart disease and heart failure; (2) Combination of severe arrhythmia or cardiogenic shock; (3) Combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or higher grade, acute myocarditis or pericarditis; (4) Combination of any disease that severely affects limb movement, such as musculoskeletal system disease or severe hepatic or renal insufficiency; (5) Combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc; Those who have serious mental illness and are unable to cooperate
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 |
|---|---|---|
| Resonance breathingResonant breathing was used on the subjects, using nasal inhalation and oral exhalation, for a total of 12 weeks. | Other | intervention group |
Primary outcome
New YorkHeart Association (NYHA)
Time frame: 12weeks
The scale is divided into four levels Grade 1 is unrestricted activity. Daily physical activity does not cause significant shortness of breath, fatigue or palpitations Grade 2 is a mild limitation of activity. Asymptomatic at rest, daily activities may cause significant shortness of breath, fatigue or palpitations Grade 3 is marked limitation of activity. May be asymptomatic at rest, but may cause significant shortness of breath, fatigue, or palpitations with less than daily activity. Grade 4 is symptomatic at rest, with discomfort associated with any physical activity. Class IVa for those who can move around indoors or at the bedside without intravenous drug administration; Class IVb for those who cannot get out of bed and require intravenous drug administration.
left ventricle global longitudinal strain, LVGLS
Time frame: 12weeks
The magnitude of overall longitudinal myocardial strain in the left ventricle on two-dimensional speckle tracking echocardiograms as an average of the peak longitudinal strain in all myocardial segments. The normal range is (-25% to -17%) in men and (-25% to -18%) in women.
2 secondary outcomes
hypertension
Time frame: 12weeks
Average heart rate
Time frame: 12weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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.
Rui Li contact
Questions about this trial
What is this clinical trial studying?
A study testing Resonance breathing in people with Long COVID and Myocardial Injury, run by Chengdu Sport University.
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 1 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 Jul 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?
Contact Rui Li (17711524016, wp100331@cdsu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New YorkHeart Association (NYHA) (time frame: 12weeks). The study lists 2 primary outcomes in all. 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 Jul 2024.