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NCT Number: NCT04751630

Effects of COVID-19 Hospitalization on Physical Performance

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Physical Disability Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Arnau de Vilanova

Lleida, 25003, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Therapeutic exercise

Other

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.

Primary outcomes

  1. Upper limb strength change

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

    handgrip strength test

Secondary outcomes

  1. Physical Performance change

    Time frame: Change from Baseline physical performance at 6 weeks

    Short Physical Performance Battery test

  2. Walking speed change

    Time frame: Change from Baseline walking speed at 6 weeks

    4 meters walking speed

  3. lower limb strength change

    Time frame: Change from Baseline lower limb strength at 6 weeks

    5 times sit and reach test

  4. Fraility change

    Time frame: Change from Baseline fraility at 6 weeks

    FRAIL scale

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2021
Registry last updated
Mar 11, 2022

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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