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Early Physiotherapy in Covid Patients

Primary Purpose

Respiratory Insufficiency, Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
physiotherapy
Sponsored by
Hospital Universitario Getafe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Susana Arias-Rivera

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Respiratory competence
Monitoring and assessment of the respiratory capacity of patients during hospital admission
Motor competence
Monitoring and assessment of patients' motor skills during hospital admission

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2021
Last Updated
March 28, 2023
Sponsor
Hospital Universitario Getafe
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1. Study Identification

Unique Protocol Identification Number
NCT05032885
Brief Title
Early Physiotherapy in Covid Patients
Official Title
RANDOMIZED CLINICAL TRIAL OF PHYSIOTHERAPY IN COVID PATIENTS ON THEIR PHYSICAL CONDITIONING, ANXIETY LEVEL AND THEIR QUALITY OF LIFE
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Getafe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Anxiety State

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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.
Arm Title
B
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Respiratory competence
Description
Monitoring and assessment of the respiratory capacity of patients during hospital admission
Time Frame
4 months
Title
Motor competence
Description
Monitoring and assessment of patients' motor skills during hospital admission
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Anxiety state
Description
assessment of the anxiety state of patients on admission and after discharge from hospital
Time Frame
4 months
Title
Variation in the level of quality of life
Description
Assessment of patients' quality of life prior to hospital admission and two months after discharge
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Susana Arias-Rivera
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early Physiotherapy in Covid Patients

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