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Completed

NCT Number: NCT04385901

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

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.

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Key information

Conditions

SARS-CoV 2 SARS Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Missouri Orthopedic Institute

Columbia, Missouri, 65202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age of <18

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. Change in Peak Flow Meter Test

    Time frame: From 6 to 24 months post diagnosis

    Measures lung output capacity

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 13, 2020
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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