Early Physiotherapy in Covid Patients

NCT05032885 | Completed

• 1 other identifier: CEIm20758
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency; Anxiety State

Outcome Measures

Primary Outcomes (2)

• Respiratory competence

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

  4 months

• Motor competence

  Monitoring and assessment of patients' motor skills during hospital admission

  4 months

Secondary Outcomes (2)

• Anxiety state

  4 months

• Variation in the level of quality of life

  4 months

Study Arms (2)

A

EXPERIMENTAL

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.

Other: physiotherapy

B

NO INTERVENTION

48-72 hours after admission to the hospital, after the patient's baseline assessment, the patient will not receive physiotherapy and the usual referral to the Rehabilitation Service for physiotherapy treatment of hospitalized patients will be followed, if the patient's physician considers it necessary and requests it.

Interventions

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.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Getafe: lead

Study Sites (1)

Susana Arias-Rivera

Getafe, Madrid, 28905, Spain

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Anxiety Disorders

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 2, 2021
• Study Start: April 4, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 30, 2022
• Last Updated: March 29, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)