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

NCT04678700 | Unknown DMC

• 1 other identifier: 20/139
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19- Coronavirus- Sars-cov-2

Keywords

chest physiotherapy; covid19; pulmonary rehabilitation covid19; physical therapy; coronavirus

Outcome Measures

Primary Outcomes (12)

• Euroqol-5d european quality of life-5 dimensions

  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".

  1 week

• Euroqol-5d european quality of life-5 dimensions

  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".

  4 week

• Dysnea scale Borg

  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

  5 minutes before each session

• Dysnea scale Borg

  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

  5 minutes after each session

• Respiratory rate

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

  5 minutes before each session

• Respiratory rate

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

  5 minutes after each session

• Effort dysnea Scale

  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.

  1 week

• Effort dysnea Scale

  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.

  4 week

• Anxiety

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

  1 week

• Anxiety

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

  4 week

• Level oxigen %

  pulxe-oximetry, the patient is sitting at rest

  1 week

• Level oxigen %

  pulxe-oximetry, the patient is sitting at rest

  4 week

Study Arms (2)

Experimental groupe

EXPERIMENTAL

Intervention; 10 sessions telematics. Before starting and at the end of the respiratory physiotherapy program, the patient complete an online form which includes a quality of life questionnaire, an effort dyspnea questionnaire and an anxiety questionnaire. The intervention of the following study follow the recommendations of chest physiotherapy in the management of the patient post covid-19 (1)(17). Pre-session; respiratory frequency, dyspnea, oxigenation level are taken. Breathing techniques; * Abdominal-diaphragmatic breathing(1)(16). (10 times). * Costal expansion exercises with flexion and abduction of the upper limbs. (10 times)(1). * Self-passive stretching of the ribcage and neck muscles, accessory to inspiration(25)(26). * Jacobson's progressive relaxation(27). Post-session, respiratory frequency and the Borg's dyspnea index/ oxigenation level.

Other: Chest physiotherapy post-covid19

control groupe

OTHER

The control group will complete the same questionnaires before and after the intervention, which will give us an idea of whether our intervention has had any improvement. In order for all patients to be able to receive the therapy if they want to. The control group will be on the waiting list to perform the sessions.

Other: Chest physiotherapy post-covid19

Interventions

Chest physiotherapy post-covid19 OTHER

The sessions are divided into the following modules; * Directed abdominal-diaphragmatic ventilation (10 times). * Costal expansion exercises with the help of flexion and abduction of the upper limbs. (10 times)(1). * Self-passive stretching of the ribcage and neck muscles, accessory to inspiration. The purpose of the stretching will be to increase the flexibility of the muscles to improve the vital capacity as has already been evidenced in other respiratory diseases such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis (25)(26). Relaxation time;Jacobson's progressive relaxation; we scan the body's condition. Post-session evaluation by taking the respiratory frequency/ min and the Borg's dyspnea index, and level oxigen after the exercises.

Experimental groupe; control groupe

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• European University of Madrid: lead

Study Sites (1)

Marta de la plaza

Madrid, 28670, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marta de la plaza

  European University of Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta de la plaza, IP

CONTACT

0034659432984; marta_delaplaza@hotmail.com

Marta de la plaza, IP

CONTACT

marta_delaplaza@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy teacher, PH student

Model Details: Experimental study composed of an intervention group and a control group The control group will receive the intervention after finishing the intervention with the experimental group.

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 22, 2020
• Study Start: March 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 3, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)