Clinical trial NCT04549337: Feasibility and Safety of High-intensity Exercise Training in Patients Surviving COVID-19
Official title: Investigator-blinded Randomized Controlled Trial Examining the Safety and Feasibility of Different Exercise Training Programs in Patients Who Have Survived COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study uses a randomized crossover trial testing the feasibility of 3 different training protocols.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 10-point Likert scale
timeFrame: Through study completion, an average of 3 months
measure: Participant adherence to the training dose
timeFrame: Through study completion, an average of 3 months
measure: Participant adherence to the training intensity
timeFrame: Through study completion, an average of 3 months
measure: Adverse effects
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Rate of perceived exertion
timeFrame: The secondary outcome measure will be evaluated through study completion, an average of 3 months
measure: Post COVID-19 Functional scale
timeFrame: The secondary outcome measure will be evaluated through study completion, an average of 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Center for Physical Activity Research, Rigshospitalet
name: Regitse Christensen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.