NCT06379672

Brief Summary

An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

August 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

April 18, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

2D-STEresonance breathingMyocardial InjuryLong Covid-19

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12weeks

Secondary Outcomes (2)

  • hypertension

    12weeks

  • Average heart rate

    12weeks

Study Arms (1)

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).

Other: Resonance breathing

Interventions

Resonant breathing was used on the subjects, using nasal inhalation and oral exhalation, for a total of 12 weeks.

intervention group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • D-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

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 23, 2024

Study Start

August 25, 2024

Primary Completion

September 25, 2024

Study Completion

October 5, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07