Early Physiotherapy in Covid Patients

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032885
• Other study ID #: CEIm20758
• Status: Completed
• Phase: N/A
• Start date: April 4, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2022
• Source: Hospital Universitario Getafe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety State
• Respiratory Insufficiency

Intervention

Other:
• physiotherapy
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.

Locations

Country	Name	City	State
Spain	Susana Arias-Rivera	Getafe	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory competence	Monitoring and assessment of the respiratory capacity of patients during hospital admission	4 months
Primary	Motor competence	Monitoring and assessment of patients' motor skills during hospital admission	4 months
Secondary	Anxiety state	assessment of the anxiety state of patients on admission and after discharge from hospital	4 months
Secondary	Variation in the level of quality of life	Assessment of patients' quality of life prior to hospital admission and two months after discharge	4 months