Clinical trial NCT04385901: 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
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV 2
SARS Pneumonia
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Age of \<18

Primary outcomes:
measure: Change in 6 Minute Walk Test
timeFrame: From 6 to 24 months post diagnosis
measure: Change in Short Form 35 (SF-36) Questionnaire
timeFrame: From 6 to 24 months post diagnosis
Secondary outcomes:
measure: Change in Strength testing
timeFrame: From 6 to 24 months post diagnosis
measure: Change in Peak Flow Meter Test
timeFrame: From 6 to 24 months post diagnosis
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopedic Institute
state: Missouri
Study officials:
References:
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.
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.
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; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
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.