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

Primary Purpose

Covid19- Coronavirus- Sars-cov-2

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Chest physiotherapy post-covid19
Sponsored by
European University of Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19- Coronavirus- Sars-cov-2 focused on measuring chest physiotherapy, covid19, pulmonary rehabilitation covid19, physical therapy, coronavirus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Marta de la plazaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental groupe

control groupe

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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".
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".
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
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
Respiratory rate
breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.
Respiratory rate
breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.
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.
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.
Anxiety
STAI, questionary of anxiety, we will take before the first session and at the end of the last session
Anxiety
STAI, questionary of anxiety, we will take before the first session and at the end of the last session
Level oxigen %
pulxe-oximetry, the patient is sitting at rest
Level oxigen %
pulxe-oximetry, the patient is sitting at rest

Secondary Outcome Measures

Full Information

First Posted
December 12, 2020
Last Updated
February 1, 2021
Sponsor
European University of Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04678700
Brief Title
Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance
Official Title
Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European University of Madrid

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19- Coronavirus- Sars-cov-2
Keywords
chest physiotherapy, covid19, pulmonary rehabilitation covid19, physical therapy, coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental groupe
Arm Type
Experimental
Arm Description
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.
Arm Title
control groupe
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Chest physiotherapy post-covid19
Intervention Description
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.
Primary Outcome Measure Information:
Title
Euroqol-5d european quality of life-5 dimensions
Description
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".
Time Frame
1 week
Title
Euroqol-5d european quality of life-5 dimensions
Description
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".
Time Frame
4 week
Title
Dysnea scale Borg
Description
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
Time Frame
5 minutes before each session
Title
Dysnea scale Borg
Description
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
Time Frame
5 minutes after each session
Title
Respiratory rate
Description
breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.
Time Frame
5 minutes before each session
Title
Respiratory rate
Description
breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.
Time Frame
5 minutes after each session
Title
Effort dysnea Scale
Description
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.
Time Frame
1 week
Title
Effort dysnea Scale
Description
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.
Time Frame
4 week
Title
Anxiety
Description
STAI, questionary of anxiety, we will take before the first session and at the end of the last session
Time Frame
1 week
Title
Anxiety
Description
STAI, questionary of anxiety, we will take before the first session and at the end of the last session
Time Frame
4 week
Title
Level oxigen %
Description
pulxe-oximetry, the patient is sitting at rest
Time Frame
1 week
Title
Level oxigen %
Description
pulxe-oximetry, the patient is sitting at rest
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta de la plaza, IP
Phone
0034659432984
Email
marta_delaplaza@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marta de la plaza, IP
Email
marta_delaplaza@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta de la plaza
Organizational Affiliation
European University of Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marta de la plaza
City
Madrid
ZIP/Postal Code
28670
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta de la plaza, IP
Phone
659432984
Email
marta_delaplaza@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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