Clinical trial NCT04751630: Effects of COVID-19 Hospitalization on Physical Performance
Official title: Effects of a Structured Online Therapeutic Exercise Program on Physical Performance in COVID-19 Patients at Discharge Time.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Physical Disability
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Upper limb strength change
timeFrame: Change from Baseline upper limb strength at 6 weeks
Secondary outcomes:
measure: Physical Performance change
timeFrame: Change from Baseline physical performance at 6 weeks
measure: Walking speed change
timeFrame: Change from Baseline walking speed at 6 weeks
measure: lower limb strength change
timeFrame: Change from Baseline lower limb strength at 6 weeks
measure: Fraility change
timeFrame: Change from Baseline fraility at 6 weeks
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Albert Pérez-Bellmunt, PhD
role: STUDY_DIRECTOR
References: