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Clinical Trials/NCT04385901
NCT04385901CompletedNot Applicable

Long Term Functional Outcomes of COVID-19 Patients Treated by Rehabilitation Services viaTelehealth

University of Missouri-Columbia2 sites in 1 country26 target enrollmentStarted: May 19, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
2
Primary Endpoint
Change in 6 Minute Walk Test

Study Overview

Brief Summary

This study seeks to assess the impact of physical and pulmonary rehabilitation on patients who have been diagnosed with COVID-19 in the short and long term in hopes of establishing a best practices protocol for treatment of future patients with this disease.

Detailed Description

The novel coronavirus that began in Wuhan, China in late 2019 made an appearance in the United States in January 2020. It is a respiratory disease spreading rapidly from person to person. Recent data shows that fibrosis is seen on the lungs, and possible myocardial damage. Data shows that physical therapy was not highly utilized in recovery for these patients due to high PPE demands, and increased risk of exposure. This study will be using telehealth services to assess and treat these patients so Physical Therapy guidance is provided for movement and returning to prior level of function. Currently there is no data showing the long term effects of the those who were able to utilize Physical Therapy in recovering from COVID-19 This study will be looking at the differences in outcomes of COVID-19 positive subjects who able to complete Physical Therapy Telehealth visits versus those who did not. All groups will be tested at multiple data points for lung capacity, upper and lower extremity strength, and overall endurance to determine the long term functional effects. The control group were diagnosed with COVID-19 and recovered before the Physical and Pulmonary protocol was implemented.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

Participants and care providers will know which group they are in, but data will be deidentified and blinded prior to analysis or viewing by the primary investigator

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • >Age of 18
  • Positive COVID-19 diagnosis in the last 6 months

Exclusion Criteria

  • Age of <18

Outcomes

Primary Outcomes

Change in 6 Minute Walk Test

Time Frame: From 6 to 24 months post diagnosis

Validated test demonstrating functional gait capacity and endurance; measuring change in capacity over time in 6 month increments.

Change in Short Form 35 (SF-36) Questionnaire

Time Frame: From 6 to 24 months post diagnosis

Validated questionnaire assessing function and quality of life for patients with pulmonary function issues

Secondary Outcomes

  • Change in Peak Flow Meter Test(From 6 to 24 months post diagnosis)
  • Change in Strength testing(From 6 to 24 months post diagnosis)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Y Stone

Manager, Clinical Rehabilitative Services

University of Missouri-Columbia

Study Sites (2)

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