The Protective Potential of Exercise Training on the Cardiopulmonary Morbidity After COVID-19
NCT ID: NCT04647734
Last Updated: 2022-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2021-02-01
2022-02-10
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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High intensity interval training
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)
High intensity interval training
12 weeks of high intensity interval training on exercise bike for 38 minutes 3 times a week
Control group
This group will be allocated to standard care and therefore no supervised exercise regimen.
Standard care
standard care after discharge from hospital (control group)
Interventions
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High intensity interval training
12 weeks of high intensity interval training on exercise bike for 38 minutes 3 times a week
Standard care
standard care after discharge from hospital (control group)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
40 Years
ALL
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Regitse Christensen
Principal investigator
Principal Investigators
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Regitse Christensen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Center for Physical Activity Research, Rigshospitalet
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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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.
Other Identifiers
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H-20033733 v.2
Identifier Type: -
Identifier Source: org_study_id
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