Effects of COVID-19 Hospitalization on Physical Performance

Covid19 Clinical Trial

Official title:

Effects of a Structured Online Therapeutic Exercise Program on Physical Performance in COVID-19 Patients at Discharge Time.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751630
• Other study ID #: CBAS-21-22
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Physical Disability

Intervention

Other:
• Therapeutic Exercise
Online and structured exercise therapeutic program based on flexibility, strength, balance and aerobic exercises. The program have been supervised by an expert on the field and it participants will perform it under the supervision of an expert physiotherapist.

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova	Lleida

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper limb strength change	handgrip strength test	Change from Baseline upper limb strength at 6 weeks
Secondary	Physical Performance change	Short Physical Performance Battery test	Change from Baseline physical performance at 6 weeks
Secondary	Walking speed change	4 meters walking speed	Change from Baseline walking speed at 6 weeks
Secondary	lower limb strength change	5 times sit and reach test	Change from Baseline lower limb strength at 6 weeks
Secondary	Fraility change	FRAIL scale	Change from Baseline fraility at 6 weeks