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Clinical Trials/NCT04678700
NCT04678700
Unknown
N/A

Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance

European University of Madrid1 site in 1 country40 target enrollmentMarch 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19- Coronavirus- Sars-cov-2
Sponsor
European University of Madrid
Enrollment
40
Locations
1
Primary Endpoint
Respiratory rate
Last Updated
5 years ago

Overview

Brief Summary

The objective of this research project is to scientifically evidence a pulmonary rehabilitation program that was initiated altruistically during the confinement of those patients who had suffered from COVID-19, through an online platform.

Patients are connected telematically 3 times a week from April 6, 2020 to perform the physical therapy program. Due to the clinical improvements that have been referred by patients, they began to take objective data.

Our goal is to know if a telematic respiratory therapy program in post-covid 19 patient, improves the level of anxiety, dyspnea on effort, improves quality of life and oxygenation.

Detailed Description

Patients affected by COVID- 19 have long periods of convalescence at home. This fact, together with the measures of social isolation, has contributed to act from a new therapeutic paradigm with the implementation of telematic rehabilitation programs. On April 6, 2020 the online platform was born under the name "Respiratory Physiotherapy; telematic assistance in patients with COVID-19 sequelae". We want to quantify the Chest Physiotherapy online program. Hypothesis; An online respiratory physiotherapy program offers improvements in quality of life, dyspnea and anxiety to patients who have suffered COVID-19. Objectives; General objective; To improve the pulmonary function of patients who have suffered from COVID-19 infection through an online respiratory physiotherapy program. Secondary objectives; * To improve the sensation of dyspnea; quantified by the Malher and Borg scale * To Normalize Breathing Rate * To Improve oxigenation; pulse-oximetry * To Improve the quality of life; quantified Euroqol- 5D * To Improve the feeling of anxiety; quantified by the STAI questionnaire METHODOLOGY/STUDY DESIGN; This is a program that was born under a very special need and circumstance, as is the coronavirus pandemic. The aim was to use respiratory tele-rehabilitation through an online platform with patients affected by coronavirus. The study is voluntary, the patient can stop the program at any time he or she considers appropriate. All of this is informed in the consent form that you give us, duly signed. I

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
August 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
European University of Madrid
Responsible Party
Principal Investigator
Principal Investigator

Marta de la Plaza

Physiotherapy teacher, PH student

European University of Madrid

Eligibility Criteria

Inclusion Criteria

  • Patients in the recovery phase, hospitalised or at home.
  • Patients diagnosed with positive PCR for COVID-19
  • Patient with sensation of dyspnea
  • Patient able to sit still

Exclusion Criteria

  • Patients admitted to intensive care and/or hemodynamically unstable
  • Patients connected to mechanical ventilation
  • Patients who do not have integrated cognitive abilities
  • Patients who are receiving other respiratory rehabilitation programs
  • Patients without adecuate technologies ( WIFI, computer, email, zoom)

Outcomes

Primary Outcomes

Respiratory rate

Time Frame: 5 minutes after each session

breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.

Euroqol-5d european quality of life-5 dimensions

Time Frame: 4 week

The EQ-5D is a generic Quality of Life measurement instrument. The individual himself evaluates his state of health, first in levels of severity by dimensions. The descriptive system contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression) and each one has three levels of severity (no problems, some moderate problems or problems and serious problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to his or her state of health in each one of the dimensions, referring to the same day that he or she completes the questionnaire. In each dimension of the EQ-5D, the levels of severity are coded with a 1 if the answer option is "no (I have) problems"; with a 2 if the answer option is "some or moderate problems"; and with a 3 if the answer option is "many problems".

Dysnea scale Borg

Time Frame: 5 minutes after each session

The modified Borg scale is a visual analog scale standardized in Spanish that allows to evaluate the subjective perception of the breathing difficulty or the physical effort exercised. This variable is taken in sedation

Anxiety

Time Frame: 4 week

STAI, questionary of anxiety, we will take before the first session and at the end of the last session

Level oxigen %

Time Frame: 4 week

pulxe-oximetry, the patient is sitting at rest

Effort dysnea Scale

Time Frame: 4 week

Effort dyspnea scale, Malher Scale A multidimensional scale that measures 3 magnitudes of dyspnea at a given time: the difficulty of the task, the intensity of the effort and the functional impairment.

Study Sites (1)

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