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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385901
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Jennifer Y Stone, 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.

Condition or disease Intervention/treatment Phase
SARS-CoV 2 SARS Pneumonia Behavioral: Therapy Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (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
Primary Purpose: Treatment
Official Title: Long Term Functional Outcomes of COVID-19 Patients Treated by Rehabilitation Services viaTelehealth
Estimated Study Start Date : May 19, 2020
Estimated Primary Completion Date : April 19, 2022
Estimated Study Completion Date : April 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
No Intervention: Standard of Care
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
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
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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Change in Strength testing [ Time Frame: From 6 to 24 months post diagnosis ]
    Use of grip dynamometer and isokinematic lower extremity testing to determine muscle capacity

  2. Change in Peak Flow Meter Test [ Time Frame: From 6 to 24 months post diagnosis ]
    Measures lung output capacity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age of <18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385901


Locations
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United States, Missouri
Missouri Orthopedic Institute
Columbia, Missouri, United States, 65202
Contact: Chelsea Harrison, DPT    573-884-0655    harrisonch@health.missouri.edu   
Contact: Jennifer Y Stone    5738841587    stonejy@health.missouri.edu   
Principal Investigator: Jennifer Y Stone, PT, DPT, OCS         
Sponsors and Collaborators
University of Missouri-Columbia
Publications of Results:
Other Publications:
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Responsible Party: Jennifer Y Stone, Manager, Clinical Rehabilitative Services, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04385901    
Other Study ID Numbers: COVID19Recovery
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections