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

NCT04385901 | Completed

• 1 other identifier: COVID19Recovery
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV 2; SARS Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Strength testing

  From 6 to 24 months post diagnosis

• Change in Peak Flow Meter Test

  From 6 to 24 months post diagnosis

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Rehabilitation Group

EXPERIMENTAL

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

Interventions

Therapy Intervention BEHAVIORAL

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.

Rehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age of \<18

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Orthopedic Institute

Columbia, Missouri, 65202, United States

Location

Related Publications (4)

• 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.

  PMID: 32164083 BACKGROUND

• 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.

  PMID: 23666438 RESULT

• 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; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/

  PMID: 32150360 RESULT

• 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.

  PMID: 22588759 RESULT

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager, Clinical Rehabilitative Services

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 13, 2020
• Study Start: May 19, 2020
• Primary Completion: September 19, 2020
• Study Completion: September 19, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)