- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06379672
Resonance Breathing Training for 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rui Li
- Phone Number: 17711524016
- Email: wp100331@cdsu.edu.cn
Study Contact Backup
- Name: Rui Li
- Phone Number: 17711524016
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- (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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
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).
|
Resonant breathing was used on the subjects, using nasal inhalation and oral exhalation, for a total of 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
12weeks
|
|
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.
|
12weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hypertension
Time Frame: 12weeks
|
Blood pressure included both systolic and diastolic blood pressure and was observed before and after the intervention for any reduction in blood pressure.
|
12weeks
|
|
Average heart rate
Time Frame: 12weeks
|
One-minute average heart rate (at rest).
|
12weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Chronic Disease
- Post-Infectious Disorders
- COVID-19
- Wounds and Injuries
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- 2023[No.193]
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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