NCT04913129

Brief Summary

This research study is being done to find out what the longer-term physiological consequences of COVID-19 are, and to determine if exercise therapy can help improve lung function, heart function and overall fitness, and reduce symptoms in people recovering from SARS-CoV-2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable covid19

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

May 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

May 31, 2021

Last Update Submit

March 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen update (VO2max) measured in mL/kg/min

    VO2max is the maximal oxygen consumed during an exhaustive exercise test

    8 weeks

Secondary Outcomes (7)

  • Peak exercise work rate (Wpeak) measured in Watts

    8 weeks

  • Forced vital capacity (FVC) measured in L

    8 weeks

  • Forced expiratory volume in 1 second (FEV1) measured in L

    8 weeks

  • Maximal inspiratory pressure (MIP) measured in cmH2O

    8 weeks

  • Maximal expiratory pressure (MEP) measured in cmH2O

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Standard physician-guided medical care after COVID-19

Interventional (exercise training) Group

EXPERIMENTAL

8 week home-based exercise training

Other: Exercise Training

Interventions

8 week home-based exercise therapy 4-5 times/week

Interventional (exercise training) Group

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 21 to 75 years.
  • History of RT-PCR proven SARS-CoV-2 infection.
  • Deemed 'recovered' from SARS-CoV-2 infection.
  • Not clinically obese (BMI ≥ 36) and/or suffer from musculoskeletal or other conditions that would limit exercise participation.
  • No evidence of cardiac ischemia at rest or during exertion (via ECG).
  • Able to provide written informed consent.

You may not qualify if:

  • Individuals less than 21 or more than 75 years old.
  • Not able to take part in structured exercise training due to injury or other conditions that would put person at risk during exercise.
  • Unable to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bryan Taylor, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 4, 2021

Study Start

November 4, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations