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
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV 2 SARS Pneumonia||Behavioral: Therapy Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|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|
|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|
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.
- 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
- 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
- Change in Peak Flow Meter Test [ Time Frame: From 6 to 24 months post diagnosis ]Measures lung output capacity
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
|United States, Missouri|
|Missouri Orthopedic Institute|
|Columbia, Missouri, United States, 65202|
|Contact: Chelsea Harrison, DPT 573-884-0655 email@example.com|
|Contact: Jennifer Y Stone 5738841587 firstname.lastname@example.org|
|Principal Investigator: Jennifer Y Stone, PT, DPT, OCS|