NCT04647734

Brief Summary

40 COVID-19 survivors that have been discharged from the hospital will be included in this investigator-blinded randomised study with a 12-week exercise intervention. Patients will be 1:1 block-randomised by sex to either a supervised high intensity interval-based exercise group or standard care (control group).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

November 25, 2020

Last Update Submit

June 3, 2022

Conditions

COVID-19, SARS-CoV2

Outcome Measures

Primary Outcomes (2)

  • Change in left ventricular mass

    measured by MRI scan

    Through study completion, an average of 12 months

  • Change in right ventricular volume

    measured by MRI scan

    Through study completion, an average of 12 months

Secondary Outcomes (39)

  • Stroke volume

    Through study completion, an average of 12 months

  • end-diastolic volume

    Through study completion, an average of 12 months

  • IVS thickness (intact ventricular septum)

    Through study completion, an average of 12 months

  • LVID (left ventricular internal dimensions)

    Through study completion, an average of 12 months

  • PWT (posterior wall thickness)

    Through study completion, an average of 12 months

  • +34 more secondary outcomes

Study Arms (2)

High intensity interval training

EXPERIMENTAL

The experimental group will on top of standard care undergo a 12 weeks supervised exercise high intensity interval exercise training on an ergometer bike three times a week for 38 minutes. The specific intervals will be determined from our ongoing pilot study (NCT04549337)

Behavioral: High intensity interval training

Control group

ACTIVE COMPARATOR

This group will be allocated to standard care and therefore no supervised exercise regimen.

Behavioral: Standard care

Interventions

High intensity interval trainingBEHAVIORAL

12 weeks of high intensity interval training on exercise bike for 38 minutes 3 times a week

High intensity interval training
Standard careBEHAVIORAL

standard care after discharge from hospital (control group)

Control group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 34794987DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

High-Intensity Interval TrainingStandard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

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
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 1, 2020

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

February 10, 2022

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

DK(1)