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Completed

NCT Number: NCT05032885

Early Physiotherapy in Covid Patients

Based on the hypothesis that early physiotherapy in patients hospitalized for COVID-19 improves their functional capacity, perceived quality of life and decreases anxiety. Our main objective is to analyze the differences between groups with respect to functional deterioration, need for oxygen therapy and anxiety when implementing an early physiotherapy program.

We propose a randomized clinical trial with two arms and single-center, to be developed in hospitalization units and intermediate respiratory care units (IRCU), with patients diagnosed with COVID. The sample will consist of an experimental group of 66 admitted patients with COVID-19 to whom an early physiotherapy program will be implemented from 48-72 hours after admission. The control group will be made up of another 66 admitted patients with COVID-19 who will receive the treatment according to the usual procedure of the hospital center.

Sociodemographic and clinical variables will be collected, including: modified MMRC dyspnea scale, amount of oxygen therapy, MRC-SS, sit to stand test, hand grip, Tinetti, HADS anxiety and depression questionnaire, SF-12 quality of life questionnaire, clinical frailty scale (CFS) and FRAIL scale. Patients in both groups will be re-evaluated two months after hospital discharge with the above variables in addition to the PCFS post-COVID patient functional status scale.

A basic descriptive analysis and logistic regression will be performed to determine the effect of the intervention.

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Key information

Conditions

Respiratory Insufficiency Anxiety Disorders Anxiety State Mental Disorders Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Susana Arias-Rivera

Getafe, Madrid, 28905, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients admitted to the hospitalization unit or intermediate respiratory care unit, diagnosed with COVID-19 pneumonia, of legal age and who consent to participate in the study. Pregnant patients or patients with dementia, terminal illnesses or those in which there are communication problems (language problems, comprehension ...) will not be included.

Exclusion criteria

  • Patients who are transferred to another acute hospital due to impossibility of completing the follow-up period, exitus during hospital admission and those who revoke consent.

Treatment and study plan

Physiotherapy

Other

Patients in the intervention group will receive early physiotherapy treatment. This intervention will consist of exercises and physiotherapy techniques commonly used and aimed at improving the patient's respiratory and motor conditioning.

At the respiratory level: diaphragmatic and costal targeted ventilation, pursed-lip breathing and bronchial hygiene techniques if required.

At the motor level: passive, active-assisted kinesitherapy and analytical and global potentiation of the upper and lower limbs that will allow the maintenance and improvement of the articular pathway and will prevent muscle weakness; retraining of transfers and balance; gait reeducation.

Primary outcomes

  1. Respiratory competence

    Time frame: 4 months

    Monitoring and assessment of the respiratory capacity of patients during hospital admission

  2. Motor competence

    Time frame: 4 months

    Monitoring and assessment of patients' motor skills during hospital admission

Secondary outcomes

  1. Anxiety state

    Time frame: 4 months

    assessment of the anxiety state of patients on admission and after discharge from hospital

  2. Variation in the level of quality of life

    Time frame: 4 months

    Assessment of patients' quality of life prior to hospital admission and two months after discharge

Sponsors and collaborators

Lead sponsor

Hospital Universitario Getafe

Other

Registry information

Official study title

RANDOMIZED CLINICAL TRIAL OF PHYSIOTHERAPY IN COVID PATIENTS ON THEIR PHYSICAL CONDITIONING, ANXIETY LEVEL AND THEIR QUALITY OF LIFE

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Mar 29, 2023

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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