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Clinical Trials/NCT04751630
NCT04751630
Completed
Not Applicable

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

Universitat Internacional de Catalunya1 site in 1 country70 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Universitat Internacional de Catalunya
Enrollment
70
Locations
1
Primary Endpoint
Upper limb strength change
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
March 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Albert Pérez Bellmunt

Doctor

Universitat Internacional de Catalunya

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Upper limb strength change

Time Frame: Change from Baseline upper limb strength at 6 weeks

handgrip strength test

Secondary Outcomes

  • Physical Performance change(Change from Baseline physical performance at 6 weeks)
  • lower limb strength change(Change from Baseline lower limb strength at 6 weeks)
  • Fraility change(Change from Baseline fraility at 6 weeks)
  • Walking speed change(Change from Baseline walking speed at 6 weeks)

Study Sites (1)

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