Effects of COVID-19 Hospitalization on Physical Performance

Not Applicable

Completed

• Conditions: Physical Disability; Covid19

• Registration Number: NCT04751630
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

Coronavirus disease (COVID-19) has resulted in millions of hospital admissions. The physical consequences caused by COVID-19 hospitalization could jeopardize the overall health status of patients through a decrease in functional capacity. A therapeutic exercise program may reduce the adverse effects of COVID-19 on functional capacity and thereby improve the overall health status of these patients.

The objectives of this project are 1) to analyze the effect of a therapeutic exercise program in patients who have been hospitalized in Intensive Care Unit (ICU) for COVID-19.

Single-blind randomized clinical trial. 118 patients post-ICU for COVID-19 will be randomized into an intervention group and a control group. The intervention group will perform a therapeutic exercise program for eight weeks in telematic modality. Functional capacity will be analyzed using the grip strength, Short Physical Performance Battery, gait speed, lower extremity strength and the FRAIL scale at baseline, eight and twelve weeks. The main statistical analysis will be a comparison of means for independent samples assessing the effect of the intervention.

Given the high prevalence of patients hospitalized for COVID-19, establishing strategies to minimize the adverse effects of the virus on patients is a must for the healthcare setting. Assessing physical condition after COVID-19 will allow the magnitude of the problem to be established. Physiotherapy, through therapeutic exercise, could improve physical fitness in these patients and thus improve the overall health status after COVID-19.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-12
• Study Start: 2021-06-01
• Primary Completion: 2022-02-01
• Status Verified: 2022-03
• Study Completion: 2022-03-01
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age 18 years or older.
• Have been diagnosed COVID-19 positive at the time of hospital admission.
• Be able to use an online platform to conduct "meetings" with the healthcare professional or have the necessary personal assistance to do so.
• Be able to read the informed consent form and understand the objectives and conduct of the study.

Exclusion Criteria

• Diagnosed neurological or psychiatric disease.
• Contraindications to physical exercise.
• Failure to give informed consent for the study.
• Unavailability to perform the ET program twice a week.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Upper limb strength change	Change from Baseline upper limb strength at 6 weeks	handgrip strength test

Secondary Outcome Measures

Name	Time	Method
Physical Performance change	Change from Baseline physical performance at 6 weeks	Short Physical Performance Battery test
lower limb strength change	Change from Baseline lower limb strength at 6 weeks	5 times sit and reach test
Fraility change	Change from Baseline fraility at 6 weeks	FRAIL scale
Walking speed change	Change from Baseline walking speed at 6 weeks	4 meters walking speed

Trial Locations

Locations (1)

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain