Resonance Breathing Training for Long Covid-related Myocardial Injury

July 29, 2024 updated by: Ping Yang, Chengdu Sport University

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

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rui Li
  • Phone Number: 17711524016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 and 60 years;
  2. 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
  3. 2D-STE suggestive of GLSAVG: -17% ≤ men ≤ -10%, -18% ≤ women ≤ -10%;
  4. Consent for enrollment based on the degree of myocardial injury, as diagnosed by a clinician;
  5. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 25, 2024

Primary Completion (Estimated)

September 25, 2024

Study Completion (Estimated)

October 5, 2024

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 21, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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