COVID-19NCT04549337
Feasibility and Safety of High-intensity Exercise Training in Patients Surviving COVID-19
A study testing Exercise training in people with COVID-19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This current protocol encompasses an investigator-blinded randomized exercise intervention in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order. 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
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Sep 2020to 1 May 2021
- 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
Official title: Investigator-blinded Randomized Controlled Trial Examining the Safety and Feasibility of Different Exercise Training Programs in Patients Who Have Survived COVID-19
This current protocol encompasses an investigator-blinded randomized exercise intervention in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.
The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.
Read the detailed description
The study is a randomized crossover trial testing the feasibility and safety of three different training protocols in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.
The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.
The study consists of 4 visits with 1 baseline session (a medical screening and fitness test) and 3 different training sessions. Each training is separated by 1-week washout, to account for potential confounding by leisure activity performed just before the training, patients will be wearing activity watches (Polar).
Feasibility and safety evaluation will be based on 1) how tolerable and enjoyable the training was based on a subjective questionnaire (Likert Scale) 2) compliance to the prescribed exercise protocol with regard to duration and intensity and 3) experienced side effects.
- Conditions
- COVID-19
- Being tested
- Exercise training
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Feasibility and safety of 3 different training protocols will be tested. Therefore the intervention is three different exercise protocols (4X4, 6X1, and 10-20-30). The exercise workload is set according to the patients HRmax or wattmax from a VO2max test at the baseline testing. All training protocols have a duration of 38 minutes and start with a 10-minute warm up and a 3-7-minute cool-down period. The intervals in the training protocols are interspersed with a 3-minute active rest. Therefore the three exercise protocols are matched on duration, and they all fall within the category of high-intensity-interval training.
The accumulated time spend with a heart rate >85% of HR max will be evaluated to determine the intensity.
| Study group | Role | What they receive |
|---|---|---|
| 4X4 | Experimental | An exercise training protocol with a duration of 38 minutes consisting of a 10 minutes warm up with a heart rate of 60-70% of HRmax followed by 4 intervals of 4 minutes at an intensity that will induce at least 85% of HRmax (we will start with 75% of watt max).
Each interval is separated by 3-minute active pauses, biking at 50-70% of HRmax. Following this a 3-minute cooldown (at warm up intensity) will be performed. Receives: Behavioral: Exercise training |
| 6X1 | Active comparator | An exercise training protocol with a duration of 38 minutes consisting of a 10 minutes warm up on 30% of watt-max followed by 6 intervals of 1 minute at 100% of the watt-max.
Each interval is interspersed by 3-minute active pauses at 30% of watt-max. Following this a 7-minute cooldown (at warm up intensity) will be performed. Receives: Behavioral: Exercise training |
| 10-20-30 | Active comparator | An exercise training protocol with a duration of 38 minutes consisting of a 10 minutes warm up at 60-70% of HRmax followed by 3 intervals of 5 minutes interspersed by 3 minutes on 50-70% of HRmax.
Each interval consists of 5 minutes of 5 repeated 30-20-10 intervals, consisting of 30 seconds at easy pace, 20 seconds at medium pace and 10 seconds at all-out. Following this a 7-minute cooldown (at warm up intensity) will be performed. Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-point Likert scale
the 10-point Likert scale, which evaluates enjoyment and perceived tolerance of each training protocol at the end of each training session using a 10-point Likert scale, which is one of the most fundamental and frequently used psychometric tools in social science research. Patients have to indicate the degree to which they agreed with the following statement before training: "How motivated are you for today's training?" following two statements after the training: "How enjoyable have today´s training session been?" and "How tolerant has today´s training been?" A higher number describes better agreement.
Measured: Through study completion, an average of 3 months
Participant adherence to the training dose
Percentage completed exercise of the total duration
Measured: Through study completion, an average of 3 months
Participant adherence to the training intensity
Percentage of the exercise session spent at a heart rate above 85% of maximal heart rate
Measured: Through study completion, an average of 3 months
Adverse effects
Adverse effect which leads to termination of the exercise training, registered as a binary outcome (yes/no)
Measured: Through study completion, an average of 3 months
Secondary outcomes (2)
Rate of perceived exertion
Verification of training intensity is evaluated by rate of perceived exertion after each interval (6-20 Borg scale) and after completed training (1-10 Borg scale), and from accumulated minutes in the predefined heart rate zones.
Measured: The secondary outcome measure will be evaluated through study completion, an average of 3 months
Post COVID-19 Functional scale
Functional capacity of the patients is another outcome which is assessed with the Post COVID-19 Functional scale, which is a scale to measure the consequence of the disease beyond binary outcomes. The scale ranges from 0-4, where 4 describes "worst functional limitation (worse outcome)".
Measured: The secondary outcome measure will be evaluated through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start25 Sep 2020
- Primary completion1 Jan 2021
- Study completion1 May 2021
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-19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a randomized crossover trial testing the feasibility of 3 different training protocols.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 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
- NCT04549337
- Sponsor's protocol ID
- H-20033733
- Other IDs
- 75068
- Status last verified
- Apr 2023
- First submitted
- 9 Sep 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data that underlie the results reported in publications from this study (after deidentification), and the analytic code can be shared beginning 6 months after publication of pre-specified primary, and secondary outcomes and ending 5 years following this to researchers, who provide a methodologically sound proposal. Proposals should be directed to the corresponding or last author of this manuscript. To gain access, data requestors will need to sign a data access agreement.
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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-blinded Randomized Controlled Trial Examining the Safety and Feasibility of Different Exercise Training Programs in Patients Who Have Survived COVID-19
- ClinicalTrials.gov ID
- NCT04549337
- Acronym / sponsor ID
- H-20033733
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 16 Sep 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.
This current protocol encompasses an investigator-blinded randomized exercise intervention in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.
The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.
Detailed description
The study is a randomized crossover trial testing the feasibility and safety of three different training protocols in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.
The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.
The study consists of 4 visits with 1 baseline session (a medical screening and fitness test) and 3 different training sessions. Each training is separated by 1-week washout, to account for potential confounding by leisure activity performed just before the training, patients will be wearing activity watches (Polar).
Feasibility and safety evaluation will be based on 1) how tolerable and enjoyable the training was based on a subjective questionnaire (Likert Scale) 2) compliance to the prescribed exercise protocol with regard to duration and intensity and 3) experienced side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This study uses a randomized crossover trial testing the feasibility of 3 different training protocols.
| Arm | Type | Receives |
|---|---|---|
| 4X4 | Experimental | Behavioral: Exercise trainingAn exercise training protocol with a duration of 38 minutes consisting of a 10 minutes warm up with a heart rate of 60-70% of HRmax followed by 4 intervals of 4 minutes at an intensity that will induce at least 85% of HRmax (we will start with 75% of watt max). Each interval is separated by 3-minute active pauses, biking at 50-70% of HRmax. Following this a 3-minute cooldown (at warm up intensity) will be performed. |
| 6X1 | Active comparator | Behavioral: Exercise trainingAn exercise training protocol with a duration of 38 minutes consisting of a 10 minutes warm up on 30% of watt-max followed by 6 intervals of 1 minute at 100% of the watt-max. Each interval is interspersed by 3-minute active pauses at 30% of watt-max. Following this a 7-minute cooldown (at warm up intensity) will be performed. |
| 10-20-30 | Active comparator | Behavioral: Exercise trainingAn exercise training protocol with a duration of 38 minutes consisting of a 10 minutes warm up at 60-70% of HRmax followed by 3 intervals of 5 minutes interspersed by 3 minutes on 50-70% of HRmax. Each interval consists of 5 minutes of 5 repeated 30-20-10 intervals, consisting of 30 seconds at easy pace, 20 seconds at medium pace and 10 seconds at all-out. Following this a 7-minute cooldown (at warm up intensity) will be performed. |
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 |
|---|---|---|
| Exercise trainingFeasibility and safety of 3 different training protocols will be tested. Therefore the intervention is three different exercise protocols (4X4, 6X1, and 10-20-30). The exercise workload is set according to the patients HRmax or wattmax from a VO2max test at the baseline testing. All training protocols have a duration of 38 minutes and start with a 10-minute warm up and a 3-7-minute cool-down period. The intervals in the training protocols are interspersed with a 3-minute active rest. Therefore the three exercise protocols are matched on duration, and they all fall within the category of high-intensity-interval training. The accumulated time spend with a heart rate >85% of HR max will be evaluated to determine the intensity. | Behavioural | 10-20-30, 4X4, 6X1 |
Primary outcome
10-point Likert scale
Time frame: Through study completion, an average of 3 months
the 10-point Likert scale, which evaluates enjoyment and perceived tolerance of each training protocol at the end of each training session using a 10-point Likert scale, which is one of the most fundamental and frequently used psychometric tools in social science research. Patients have to indicate the degree to which they agreed with the following statement before training: "How motivated are you for today's training?" following two statements after the training: "How enjoyable have today´s training session been?" and "How tolerant has today´s training been?" A higher number describes better agreement.
Participant adherence to the training dose
Time frame: Through study completion, an average of 3 months
Percentage completed exercise of the total duration
Participant adherence to the training intensity
Time frame: Through study completion, an average of 3 months
Percentage of the exercise session spent at a heart rate above 85% of maximal heart rate
Adverse effects
Time frame: Through study completion, an average of 3 months
Adverse effect which leads to termination of the exercise training, registered as a binary outcome (yes/no)
2 secondary outcomes
Rate of perceived exertion
Time frame: The secondary outcome measure will be evaluated through study completion, an average of 3 months
Post COVID-19 Functional scale
Time frame: The secondary outcome measure will be evaluated through study completion, an average of 3 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 12 Apr 2023.
- 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.
- Individual participant dataSharing planned: Undecided. Individual participant data that underlie the results reported in publications from this study (after deidentification), and the analytic code can be shared beginning 6 months after publication of pre-specified primary, and secondary outcomes and ending 5 years following this to researchers, who provide a methodologically sound proposal. Proposals should be directed to the corresponding or last author of this manuscript. To gain access, data requestors will need to sign a data access agreement.
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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 Exercise training in people with COVID-19, 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 12 Apr 2023. 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?
10-point Likert scale (time frame: Through study completion, an average of 3 months). The study lists 4 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 NCT04549337, 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 12 Apr 2023.