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

SARS-CoV 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385901
• Other study ID #: COVID19Recovery
• Status: Completed
• Phase: N/A
• Start date: May 19, 2020
• Est. completion date: September 19, 2020

Study information

• Verified date: February 2021
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 19, 2020
• Est. primary completion date: September 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >Age of 18

• Positive COVID-19 diagnosis in the last 6 months

Exclusion Criteria:

• Age of <18

Related Conditions & MeSH terms

• Pneumonia
• SARS Pneumonia
• SARS-CoV 2

Intervention

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.

Locations

Country	Name	City	State
United States	Missouri Orthopedic Institute	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 Healt — View Citation

Cascella M, Rajnik M, Cuomo A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus. 2020 Oct 4. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Strength testing	Use of grip dynamometer and isokinematic lower extremity testing to determine muscle capacity	From 6 to 24 months post diagnosis
Secondary	Change in Peak Flow Meter Test	Measures lung output capacity	From 6 to 24 months post diagnosis