Feasibility and Safety of High-intensity Exercise Training in Patients Surviving COVID-19

COVID-19 Clinical Trial

Official title:

Investigator-blinded Randomized Controlled Trial Examining the Safety and Feasibility of Different Exercise Training Programs in Patients Who Have Survived COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549337
• Other study ID #: H-20033733
• Secondary ID: 75068
• Status: Completed
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: April 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Exercise 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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 3 months
Primary	Participant adherence to the training dose	Percentage completed exercise of the total duration	Through study completion, an average of 3 months
Primary	Participant adherence to the training intensity	Percentage of the exercise session spent at a heart rate above 85% of maximal heart rate	Through study completion, an average of 3 months
Primary	Adverse effects	Adverse effect which leads to termination of the exercise training, registered as a binary outcome (yes/no)	Through study completion, an average of 3 months
Secondary	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.	The secondary outcome measure will be evaluated through study completion, an average of 3 months
Secondary	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)".	The secondary outcome measure will be evaluated through study completion, an average of 3 months