Long COVIDNCT06404411
The Efficacy of Aerobic Exercise in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury
A study testing Assigned interventions and conventional rehabilitation in people with Long COVID and Myocardial Injury, run by Chengdu Sport University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID, Myocardial Injury
- What is being tested?
- Assigned interventions and conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 30 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study of the Efficacy of Aerobic Exercise Based on Cardiopulmonary Exercise Test in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury
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
- Long COVID, Myocardial Injury
- Being tested
- Assigned interventions, conventional rehabilitation
- 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.
Assigned interventionsOther
Also called aerobic endurance exercise
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.
conventional rehabilitationOther
Adoption of conventional rehabilitation, drug therapy, enhanced nutritional support and other conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Other: Assigned interventions; Other: conventional rehabilitation |
| control group | Active comparator | Not described Receives: Other: conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (11)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06404411
- Sponsor's protocol ID
- 2024058H
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy of Aerobic Exercise Based on Cardiopulmonary Exercise Test in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury
- ClinicalTrials.gov ID
- NCT06404411
- Acronym / sponsor ID
- 2024058H
- Conditions
- Long COVID, Myocardial Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chengdu Sport UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 May 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.
A study of the efficacy of aerobic exercise based on cardiopulmonary exercise test in the rehabilitation of patients with COVID-19-related myocardial injury
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Assigned interventions, Other: conventional rehabilitation |
| control group | Active comparator | Other: conventional rehabilitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Assigned interventionsAlso: aerobic endurance exerciseCombined 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. | Other | intervention group |
| conventional rehabilitationAdoption of conventional rehabilitation, drug therapy, enhanced nutritional support and other conventional treatment | Other | control group, intervention group |
Primary outcome
VO2peak
Time frame: 12 weeks
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).
11 secondary outcomes
METpeak
Time frame: 12 weeks
AT
Time frame: 12 weeks
VEpeak
Time frame: 12 weeks
BR
Time frame: 12 weeks
VO2/HRpeak
Time frame: 12 weeks
Six-minute walk test distance, 6MWD
Time frame: 12 weeks
SDNN
Time frame: 12 weeks
SDANN
Time frame: 12 weeks
RMSSD
Time frame: 12 weeks
physical composite scale，PCS
Time frame: 12 weeks
mental health composite scale，MCS
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned interventions and conventional rehabilitation 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 10 inclusion and 8 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 13 May 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 YIPING CHEN (18066337119, 836254592@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (time frame: 12 weeks). 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 13 May 2024.