Early Physiotherapy in Covid Patients

Not Applicable

Completed

• Conditions: Anxiety State; Respiratory Insufficiency
• Interventions: Other: physiotherapy

• Registration Number: NCT05032885
• Lead Sponsor: Hospital Universitario Getafe

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-04
• Primary Completion: 2021-09-01
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-02
• Status Verified: 2022-03
• Study Completion: 2022-09-30
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	physiotherapy	48-72 hours after hospital admission, following the baseline assessment of the patient, they will begin to receive physiotherapy treatment with respiratory techniques and motor training, adapted at all times to the clinical situation of the patient, until hospital discharge. If the patient's clinical condition worsens, treatment will be temporarily suspended until the patient improves to allow resumption of treatment.

Primary Outcome Measures

Name	Time	Method
Respiratory competence	4 months	Monitoring and assessment of the respiratory capacity of patients during hospital admission
Motor competence	4 months	Monitoring and assessment of patients' motor skills during hospital admission

Secondary Outcome Measures

Name	Time	Method
Anxiety state	4 months	assessment of the anxiety state of patients on admission and after discharge from hospital
Variation in the level of quality of life	4 months	Assessment of patients' quality of life prior to hospital admission and two months after discharge

Trial Locations

Locations (1)

Susana Arias-Rivera; 🇪🇸 Getafe, Madrid, Spain