COVID-19
Conditions
Brief 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. 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.
Interventions
BEHAVIORALExercise training
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.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are randomly allocated following successful completion of the baseline measurements. A researcher, that is not involved in testing or training procedures, generates a computer-generated block randomization schedule with balanced permutations. To ascertain allocation concealment, the block sizes will not be disclosed. The schedule is forwarded to a research assistant, who is not involved in any study procedures and stored on a password protected computer. Following the baseline measurements, the participants are given consecutive numbers. These are forwarded to the research assistant, who returns the corresponding allocation sequence to the study coordinator. The participants are blinded for treatment allocation until treatment assignment. However, following the initial two treatments blinding of the participants is no longer possible. All study personal involved with data collection will be blinded during baseline testing.
Intervention model description
This study uses a randomized crossover trial testing the feasibility of 3 different training protocols.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10-point Likert scale | 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 | Through study completion, an average of 3 months | Percentage completed exercise of the total duration |
| Participant adherence to the training intensity | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of perceived exertion | The secondary outcome measure will be evaluated through study completion, an average of 3 months | 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. |
| Post COVID-19 Functional scale | The secondary outcome measure will be evaluated through study completion, an average of 3 months | 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). |
Countries
Denmark
Outcome results
None listed