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

Primary Purpose

SARS-CoV 2, SARS Pneumonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapy Intervention
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Age of <18

Sites / Locations

  • Missouri Orthopedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Rehabilitation Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in 6 Minute Walk Test
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
Validated questionnaire assessing function and quality of life for patients with pulmonary function issues

Secondary Outcome Measures

Change in Strength testing
Use of grip dynamometer and isokinematic lower extremity testing to determine muscle capacity
Change in Peak Flow Meter Test
Measures lung output capacity

Full Information

First Posted
May 6, 2020
Last Updated
February 4, 2021
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04385901
Brief Title
Long Term Functional Outcomes of COVID-19 Patients Treated by Rehabilitation Services viaTelehealth
Official Title
Long Term Functional Outcomes of COVID-19 Patients Treated by Rehabilitation Services viaTelehealth
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
September 19, 2020 (Actual)
Study Completion Date
September 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV 2, SARS Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Rehabilitation Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapy Intervention
Intervention Description
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 Measure Information:
Title
Change in 6 Minute Walk Test
Description
Validated test demonstrating functional gait capacity and endurance; measuring change in capacity over time in 6 month increments.
Time Frame
From 6 to 24 months post diagnosis
Title
Change in Short Form 35 (SF-36) Questionnaire
Description
Validated questionnaire assessing function and quality of life for patients with pulmonary function issues
Time Frame
From 6 to 24 months post diagnosis
Secondary Outcome Measure Information:
Title
Change in Strength testing
Description
Use of grip dynamometer and isokinematic lower extremity testing to determine muscle capacity
Time Frame
From 6 to 24 months post diagnosis
Title
Change in Peak Flow Meter Test
Description
Measures lung output capacity
Time Frame
From 6 to 24 months post diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >Age of 18 Positive COVID-19 diagnosis in the last 6 months Exclusion Criteria: Age of <18
Facility Information:
Facility Name
Missouri Orthopedic Institute
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32164083
Citation
Yang F, Liu N, Hu JY, Wu LL, Su GS, Zhong NS, Zheng ZG. [Pulmonary rehabilitation guidelines in the principle of 4S for patients infected with 2019 novel coronavirus (2019-nCoV)]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):180-182. doi: 10.3760/cma.j.issn.1001-0939.2020.03.007. Chinese.
Results Reference
background
PubMed Identifier
23666438
Citation
Holland AE, Hill CJ, Rochford P, Fiore J, Berlowitz DJ, McDonald CF. Telerehabilitation for people with chronic obstructive pulmonary disease: feasibility of a simple, real time model of supervised exercise training. J Telemed Telecare. 2013 Jun;19(4):222-6. doi: 10.1177/1357633x13487100. Epub 2013 May 23.
Results Reference
result
PubMed Identifier
32150360
Citation
Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
Results Reference
result
PubMed Identifier
22588759
Citation
Busija L, Pausenberger E, Haines TP, Haymes S, Buchbinder R, Osborne RH. Adult measures of general health and health-related quality of life: Medical Outcomes Study Short Form 36-Item (SF-36) and Short Form 12-Item (SF-12) Health Surveys, Nottingham Health Profile (NHP), Sickness Impact Profile (SIP), Medical Outcomes Study Short Form 6D (SF-6D), Health Utilities Index Mark 3 (HUI3), Quality of Well-Being Scale (QWB), and Assessment of Quality of Life (AQoL). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S383-412. doi: 10.1002/acr.20541. No abstract available.
Results Reference
result

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

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