COVID-19, SARS-CoV2NCT04647734
The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19
A study testing High intensity interval training in people with COVID-19, SARS-CoV2, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
40 COVID-19 survivors that have been discharged from the hospital will be included in this investigator-blinded randomised study with a 12-week exercise intervention. Patients will be 1:1 block-randomised by sex to either a supervised high intensity interval-based exercise group or standard care (control group). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV2
- What is being tested?
- High intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2021to 10 Feb 2022
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years
- A laboratory-confirmed initial positive test followed by one negative tests of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 6 months after hospital discharge
- ≤10 L oxygen requirement during hospitalization
Who cannot join
- Present atrial fibrillation
- Diagnosed with acute myocarditis
- Health conditions that prevent participating in the exercise intervention
- Patients who cannot undergo MR scans (e.g. kidney disease or metallic implants)
- Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.
Trial locations and contacts
1 site in 1 country.
About this study
40 COVID-19 survivors that have been discharged from the hospital will be included in this investigator-blinded randomised study with a 12-week exercise intervention. Patients will be 1:1 block-randomised by sex to either a supervised high intensity interval-based exercise group or standard care (control group).
Read the detailed description
40 patients will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, Pulmonary function, VO2max, RM, plasma volume, AX3, CGM, echocardiography, cardiac MRI.
After baseline testing, participants will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, both groups will complete a series of follow-up tests (as baseline testing). A 1-year follow-up experimental day is also planned in order to evaluate fitness, cardiac and pulmonary structure and function.
- Conditions
- COVID-19, SARS-CoV2
- Being tested
- High intensity interval training, Standard care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
12 weeks of high intensity interval training on exercise bike for 38 minutes 3 times a week
Standard careBehavioural
standard care after discharge from hospital (control group)
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | The experimental group will on top of standard care undergo a 12 weeks supervised exercise high intensity interval exercise training on an ergometer bike three times a week for 38 minutes. The specific intervals will be determined from our ongoing pilot study (NCT04549337) Receives: Behavioral: High intensity interval training |
| Control group | Active comparator | This group will be allocated to standard care and therefore no supervised exercise regimen. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass
measured by MRI scan
Measured: Through study completion, an average of 12 months
Change in right ventricular volume
measured by MRI scan
Measured: Through study completion, an average of 12 months
Secondary outcomes (39)
Stroke volume
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
end-diastolic volume
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
IVS thickness (intact ventricular septum)
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
LVID (left ventricular internal dimensions)
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
PWT (posterior wall thickness)
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
LAVI (left atrial volume index)
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
LVEF
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
Global longitudinal strain
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
E/A ratio
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
E´
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
RV volumes
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
RVEF
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
TAPSE
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
Change in maximal tricuspid regurgitation velocity and pressure gradient
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
RV s´
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
Peak E velocity
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
Peak A velocity
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
Septal e´
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
Lateral e´
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
E/e´ septal
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
E/e´ lateral
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: Through study completion, an average of 12 months
Cardiac inflammation
measured with gadolinium and MRI scan
Measured: Through study completion, an average of 12 months
Vascular dysfunction
measured with gadolinium and MRI scan
Measured: Through study completion, an average of 12 months
Extracellular volume
measured with gadolinium and MRI scan
Measured: Through study completion, an average of 12 months
Diffuse fibrotic changes
measured with gadolinium and MRI scan
Measured: Through study completion, an average of 12 months
Blood and plasma volume
changes
Measured: Through study completion, an average of 12 months
Body composition analysis measured with DXA
easuring Lean mass, Fat mass and BMD
Measured: Through study completion, an average of 12 months
Cardiorespiratory fitness
Measured with an incremental VO2 protocol on exercise bike
Measured: Through study completion, an average of 12 months
Dynamic spirometri
Pulmonary function testing
Measured: Through study completion, an average of 12 months
Whole body plethymography
Pulmonary function testing
Measured: Through study completion, an average of 12 months
Diffusion capacity
Pulmonary function testing
Measured: Through study completion, an average of 12 months
Oral glucose tolerance test
75g of glucose taken while fasting
Measured: 2 hours at baseline and same after intervention
Continuous glucose monitoring
Three days of continuous glucose monitoring (CGM) is performed using enzyme-coated electrodes (iPro MMT- 7745WW; Medtronic, Northridge, CA, USA) placed subcutaneously in the abdominal wall. For calibration of the CGM system, finger-prick blood glucose measurements are performed by the participant four times daily.
Measured: 3 days at baseline and same after intervention
Axial accelerometer-based physical activity monitors
Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 4-day period
Measured: 4 days at baseline and same after intervention
Blood samples analysed for markers related to low grade inflammation
Including high-sensitivity C-reactive protein, tumour necrosis factor-α, IL-1RA, interferon-γ and interleukins (IL-6, IL-10 and others)
Following an overnight fast (10 hours), blood samples, are collected and processed by a trained laboratory technician and analysed according to standard procedures. Plasma is stored at - 80 °C prior to analysis.
Measured: Through study completion, an average of 12 months
Blood samples analysed for markers related to cardiometabolic biomarkers.
Including total troponins, D-dimer, creatinine kinase, total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, glycated haemoglobin, fasting insulin, fasting plasma glucose, pro-brain natriuretic peptide, haematology, electrolytes and liver and renal status.
Following an overnight fast (10 hours), blood samples, are collected and processed by a trained laboratory technician and analysed according to standard procedures. Plasma is stored at - 80 °C prior to analysis.
Measured: Through study completion, an average of 12 months
SF-36, King´s Brief Interstitial Lung Disease Questionnaire, Post-COVID-19 Functional Status
Questionnaires on quality of life will be filled in on baseline and after the intervention
Measured: Through study completion, an average of 12 months
King´s Brief Interstitial Lung Disease Questionnaire
Questionnaires on quality of life will be filled in on baseline and after the intervention
Measured: Through study completion, an average of 12 months
Post-COVID-19 Functional Status
Questionnaires on quality of life will be filled in on baseline and after the intervention
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Feb 2021
- Primary completion1 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19, SARS-CoV2Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regitse Christensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Regitse Christensen, MD, PhD, Principal investigator, Center for Physical Activity Research, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647734
- Sponsor's protocol ID
- H-20033733 v.2
- Status last verified
- Jun 2022
- First submitted
- 25 Nov 2020
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rasmussen IE, Foged F, Bjorn Budde J, Rasmussen RS, Rasmussen V, Lyngbaek M, Jonck S, Krogh-Madsen R, Lindegaard B, Ried-Larsen M, Jorgensen PG, Lund MAV, Kober L, Vejlstrup N, Pedersen BK, Berg RMG, Christensen RH. Protective potential of high-intensity interval training on cardiac structure and function after COVID-19: protocol and statistical analysis plan for an investigator-blinded randomised controlled trial. BMJ Open. 2021 Nov 18;11(11):e048281. doi: 10.1136/bmjopen-2020-048281.
PubMed 34794987
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19
- ClinicalTrials.gov ID
- NCT04647734
- Acronym / sponsor ID
- H-20033733 v.2
- Conditions
- COVID-19, SARS-CoV2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 1 Dec 2020 (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.
40 COVID-19 survivors that have been discharged from the hospital will be included in this investigator-blinded randomised study with a 12-week exercise intervention. Patients will be 1:1 block-randomised by sex to either a supervised high intensity interval-based exercise group or standard care (control group).
Detailed description
40 patients will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, Pulmonary function, VO2max, RM, plasma volume, AX3, CGM, echocardiography, cardiac MRI.
After baseline testing, participants will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, both groups will complete a series of follow-up tests (as baseline testing). A 1-year follow-up experimental day is also planned in order to evaluate fitness, cardiac and pulmonary structure and function.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Experimental | Behavioral: High intensity interval trainingThe experimental group will on top of standard care undergo a 12 weeks supervised exercise high intensity interval exercise training on an ergometer bike three times a week for 38 minutes. The specific intervals will be determined from our ongoing pilot study (NCT04549337) |
| Control group | Active comparator | Behavioral: Standard careThis group will be allocated to standard care and therefore no supervised exercise regimen. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 40 years
- A laboratory-confirmed initial positive test followed by one negative tests of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 6 months after hospital discharge
- ≤10 L oxygen requirement during hospitalization
Key exclusion criteria (5 listed)
- Present atrial fibrillation
- Diagnosed with acute myocarditis
- Health conditions that prevent participating in the exercise intervention
- Patients who cannot undergo MR scans (e.g. kidney disease or metallic implants)
- Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.
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 |
|---|---|---|
| High intensity interval training12 weeks of high intensity interval training on exercise bike for 38 minutes 3 times a week | Behavioural | High intensity interval training |
| Standard carestandard care after discharge from hospital (control group) | Behavioural | Control group |
Primary outcome
Change in left ventricular mass
Time frame: Through study completion, an average of 12 months
measured by MRI scan
Change in right ventricular volume
Time frame: Through study completion, an average of 12 months
measured by MRI scan
39 secondary outcomes
Stroke volume
Time frame: Through study completion, an average of 12 months
end-diastolic volume
Time frame: Through study completion, an average of 12 months
IVS thickness (intact ventricular septum)
Time frame: Through study completion, an average of 12 months
LVID (left ventricular internal dimensions)
Time frame: Through study completion, an average of 12 months
PWT (posterior wall thickness)
Time frame: Through study completion, an average of 12 months
LAVI (left atrial volume index)
Time frame: Through study completion, an average of 12 months
LVEF
Time frame: Through study completion, an average of 12 months
Global longitudinal strain
Time frame: Through study completion, an average of 12 months
E/A ratio
Time frame: Through study completion, an average of 12 months
E´
Time frame: Through study completion, an average of 12 months
RV volumes
Time frame: Through study completion, an average of 12 months
RVEF
Time frame: Through study completion, an average of 12 months
TAPSE
Time frame: Through study completion, an average of 12 months
Change in maximal tricuspid regurgitation velocity and pressure gradient
Time frame: Through study completion, an average of 12 months
RV s´
Time frame: Through study completion, an average of 12 months
Peak E velocity
Time frame: Through study completion, an average of 12 months
Peak A velocity
Time frame: Through study completion, an average of 12 months
Septal e´
Time frame: Through study completion, an average of 12 months
Lateral e´
Time frame: Through study completion, an average of 12 months
E/e´ septal
Time frame: Through study completion, an average of 12 months
E/e´ lateral
Time frame: Through study completion, an average of 12 months
Cardiac inflammation
Time frame: Through study completion, an average of 12 months
Vascular dysfunction
Time frame: Through study completion, an average of 12 months
Extracellular volume
Time frame: Through study completion, an average of 12 months
Diffuse fibrotic changes
Time frame: Through study completion, an average of 12 months
Blood and plasma volume
Time frame: Through study completion, an average of 12 months
Body composition analysis measured with DXA
Time frame: Through study completion, an average of 12 months
Cardiorespiratory fitness
Time frame: Through study completion, an average of 12 months
Dynamic spirometri
Time frame: Through study completion, an average of 12 months
Whole body plethymography
Time frame: Through study completion, an average of 12 months
Diffusion capacity
Time frame: Through study completion, an average of 12 months
Oral glucose tolerance test
Time frame: 2 hours at baseline and same after intervention
Continuous glucose monitoring
Time frame: 3 days at baseline and same after intervention
Axial accelerometer-based physical activity monitors
Time frame: 4 days at baseline and same after intervention
Blood samples analysed for markers related to low grade inflammation
Time frame: Through study completion, an average of 12 months
Blood samples analysed for markers related to cardiometabolic biomarkers.
Time frame: Through study completion, an average of 12 months
SF-36, King´s Brief Interstitial Lung Disease Questionnaire, Post-COVID-19 Functional Status
Time frame: Through study completion, an average of 12 months
King´s Brief Interstitial Lung Disease Questionnaire
Time frame: Through study completion, an average of 12 months
Post-COVID-19 Functional Status
Time frame: Through study completion, an average of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 34794987Rasmussen IE, Foged F, Bjorn Budde J, Rasmussen RS, Rasmussen V, Lyngbaek M, Jonck S, Krogh-Madsen R, Lindegaard B, Ried-Larsen M, Jorgensen PG, Lund MAV, Kober L, Vejlstrup N, Pedersen BK, Berg RMG, Christensen RH. Protective potential of high-intensity interval training on cardiac structure and function after COVID-19: protocol and statistical analysis plan for an investigator-blinded randomised controlled trial. BMJ Open. 2021 Nov 18;11(11):e048281. doi: 10.1136/bmjopen-2020-048281.
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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.
Regitse Christensen, MD, PhD principal investigator
Center for Physical Activity Research, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training in people with COVID-19, SARS-CoV2, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular mass (time frame: Through study completion, an average of 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647734, which also lists 1 linked publication.
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 8 Jun 2022.