Status unknownNCT06404411Updated May 13, 2024

The Efficacy of Aerobic Exercise in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury

An interventional study of Assigned interventions and conventional rehabilitation in Long COVID and Myocardial Injury, sponsored by Chengdu Sport University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-13.

Sponsored by Chengdu Sport University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Non-randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

A study of the efficacy of aerobic exercise based on cardiopulmonary exercise test in the rehabilitation of patients with COVID-19-related myocardial injury

Conditions studied

Long COVID
Myocardial Injury

Browse trials for

Post-Acute COVID-19 Syndrome 536

In context

Post-Acute COVID-19 Syndrome

536 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 187 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 369 interventional studies indexed under Post-Acute COVID-19 Syndrome.

Browse Post-Acute COVID-19 Syndrome studies →

Lead sponsor

Chengdu Sport University is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Between the ages of 18 and 65 years;
A history of new coronavirus infection;
Patients with a clinical diagnosis of COVID-19-related myocardial injury;
In the late stages of recovery from COVID-19-related myocardial injury, at least 3 months after diagnosis;
Negative cardiopulmonary exercise test;
After completing respiratory rehabilitation at our hospital in the previous period;
Normal blood biomarker tests and essentially normal 2D-STE, normal left ventricular systolic function, no spontaneous or inducible arrhythmias on electrocardiographic monitoring, and the patient's clinical status is stable, with most of the symptoms in significant remission, and the daily still activities are intolerant or do not reach the pre-disease exercise level;
Classification of nyha heart function of class I or II;
Voluntarily sign the informed consent form;
Not participating in other clinical trials.

Exclusion criteria

Exclusion Criteria:

a previous history of coronary atherosclerotic heart disease and heart failure;
a combination of severe arrhythmia or cardiogenic shock;
a combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or greater severity, acute myocarditis or pericarditis;
a combination of any disease that severely affects limb movement, such as musculoskeletal disorders or severe hepatic or renal insufficiency
a combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc;
those who have serious mental illness and are unable to cooperate
those with incomplete clinical data;
those who have dropped out or terminated the trial by themselves.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 40 participants (estimated)

Study arms

Experimental
intervention group
Other: Assigned interventions · Other: conventional rehabilitation
Active comparator
control group
Other: conventional rehabilitation

Interventions

OtherAssigned interventions
Combined aerobic endurance exercise in the control group: individualized exercise prescription, including 5-10 minutes of pre-exercise dynamic stretching and warm-up, 10-30 minutes of formal aerobic exercise, and 5-10 minutes of post-exercise stretching, formal aerobic exercise using a power bike starting from low-intensity and gradually increasing to medium-high-intensity, with a frequency of five times per week.
Also known as: aerobic endurance exercise
Otherconventional rehabilitation
Adoption of conventional rehabilitation, drug therapy, enhanced nutritional support and other conventional treatment

What researchers measure

Primary outcomes

VO2peak
All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).
Time frame: 12 weeks

Secondary outcomes

METpeak
All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).
Time frame: 12 weeks
AT
All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).
Time frame: 12 weeks
VEpeak
All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).
Time frame: 12 weeks
BR
All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).
Time frame: 12 weeks
VO2/HRpeak
All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).
Time frame: 12 weeks
Six-minute walk test distance, 6MWD
Select a 30-meter-long section of the corridor and post the location of the starting and ending points. Subjects were instructed to walk back and forth through the 30-meter passageway for 6 minutes, covering the longest distance as fast as they could.
Time frame: 12 weeks
SDNN
Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.
Time frame: 12 weeks
SDANN
Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.
Time frame: 12 weeks
RMSSD
Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.
Time frame: 12 weeks
physical composite scale，PCS
The SF-12v2 is a shortened version of the scale developed based on the SF-36, which is comprehensive, simple, and less time-consuming, and is used to evaluate subjects' quality of life with 12 entries and 8 dimensions: general health, somatic functioning, somatic functioning, bodily pain, vitality, social functioning, affective functioning, and mental health. The higher the score, the better the quality of life and functional status of the patient.
Time frame: 12 weeks
mental health composite scale，MCS
The SF-12v2 is a shortened version of the scale developed based on the SF-36, which is comprehensive, simple, and less time-consuming, and is used to evaluate subjects' quality of life with 12 entries and 8 dimensions: general health, somatic functioning, somatic functioning, bodily pain, vitality, social functioning, affective functioning, and mental health. The higher the score, the better the quality of life and functional status of the patient.
Time frame: 12 weeks

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2024; primary completion for Jun 2025, 12 months later.

Of 198 non-industry interventional studies with no phase under Post-Acute COVID-19 Syndrome, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's planned 12 months is below that.

Counting every sponsor, half of 207 studies reached it within 19 months; a quarter within 10 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered: May 7, 2024
First posted: May 8, 2024
StartEst.: Jun 30, 2024
Primary completionEst.: Jun 30, 2025
CompletionEst.: Dec 30, 2025
Last update: May 13, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06404411
Lead sponsor: Chengdu Sport University
Responsible party: Ping Yang (Clinical Professor, Chengdu Sport University) — Principal investigator
First posted: May 8, 2024
Start date: Jun 30, 2024 (estimated)
Primary completion: Jun 30, 2025 (estimated)
Completion: Dec 30, 2025 (estimated)
Last update: May 13, 2024

Study contacts

YIPING CHEN

Contact

836254592@qq.com

18066337119

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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