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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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SARS-CoV 2, SARS Pneumonia

Intervention / Treatment
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* Behavioral: Therapy Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >Age of 18 Positive COVID-19 diagnosis in the last 6 months Exclusion Criteria: Age of <18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients receiving care through the program developed by the University of Missouri Healthcare system will, if willing, return for follow up testing and be compared against a matched group that did not receive the rehabilitative treatment to see if there are short or long term differences.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>These are patients who were diagnosed with COVID19 and recovered with usual care prior to implementation of the rehabilitation program developed by MUHC therapists. These patients will be selected in such a way as to match the approximate demographics that exist within the treatment group. These patients received education and supportive care only. | |
| Experimental: Rehabilitation Group<br>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. | Behavioral: Therapy Intervention<br>* Patients receive 2-4 visits (based on patient presentation and need) of physical therapy, up to 4 visits of occupational therapy, up to 4 visits of speech therapy based on need. Treatment focuses on physical strengthening, pulmonary strengthening/breathing exercises, and cognitive rehabilitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 Minute Walk Test | Validated test demonstrating functional gait capacity and endurance; measuring change in capacity over time in 6 month increments. | From 6 to 24 months post diagnosis | 
| Change in Short Form 35 (SF-36) Questionnaire | Validated questionnaire assessing function and quality of life for patients with pulmonary function issues | From 6 to 24 months post diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Strength testing | Use of grip dynamometer and isokinematic lower extremity testing to determine muscle capacity | From 6 to 24 months post diagnosis | 
| Change in Peak Flow Meter Test | Measures lung output capacity | From 6 to 24 months post diagnosis |