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

Not Applicable

Completed

• Conditions: SARS Pneumonia; SARS-CoV 2
• Interventions: Behavioral: Therapy Intervention

• Registration Number: NCT04385901
• Lead Sponsor: University of Missouri-Columbia

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 Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Study Start: 2020-05-19
• Primary Completion: 2020-09-19
• Study Completion: 2020-09-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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

Exclusion Criteria

• Age of <18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation Group	Therapy Intervention	These are patients who were diagnosed with COVID19 and participated in the physical and pulmonary rehabilitation program developed at MU Healthcare as described in the study design.

Primary Outcome Measures

Name	Time	Method
Change in 6 Minute Walk Test	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	From 6 to 24 months post diagnosis	Validated questionnaire assessing function and quality of life for patients with pulmonary function issues

Secondary Outcome Measures

Name	Time	Method
Change in Peak Flow Meter Test	From 6 to 24 months post diagnosis	Measures lung output capacity
Change in Strength testing	From 6 to 24 months post diagnosis	Use of grip dynamometer and isokinematic lower extremity testing to determine muscle capacity

Trial Locations

Locations (1)

Missouri Orthopedic Institute; 🇺🇸 Columbia, Missouri, United States