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

NCT04549337 | Completed

• 2 other identifiers: H-2003373375068
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• 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

• Participant adherence to the training dose

  Percentage completed exercise of the total duration

  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

  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)

  Through study completion, an average of 3 months

Secondary Outcomes (2)

• Rate of perceived exertion

  The secondary outcome measure will be evaluated through study completion, an average of 3 months

• Post COVID-19 Functional scale

  The secondary outcome measure will be evaluated through study completion, an average of 3 months

Study Arms (3)

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.

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.

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.

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

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.

10-20-30; 4X4; 6X1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34794987 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Regitse Christensen, MD PhD

  Center for Physical Activity Research, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This study uses a randomized crossover trial testing the feasibility of 3 different training protocols.

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 25, 2020
• Primary Completion: January 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

DK (1)