Feasibility and Safety of High-intensity Exercise Training in Patients Surviving COVID-19
- Conditions
- COVID-19
- Interventions
- Behavioral: Exercise training
- Registration Number
- NCT04549337
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 6X1 Exercise training 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. 10-20-30 Exercise training 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. 4X4 Exercise training 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.
- Primary Outcome Measures
Name Time Method 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)
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
- Secondary Outcome Measures
Name Time Method 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)".
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark