CClinicalTrials.gg
Status unknownNCT04678700Updated Feb 3, 2021

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

An interventional study of Chest physiotherapy post-covid19 in Covid19- Coronavirus- Sars-cov-2, sponsored by European University of Madrid. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by European University of Madrid · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Covid19- Coronavirus- Sars-cov-2

Keywords

  • chest physiotherapy
  • covid19
  • pulmonary rehabilitation covid19
  • physical therapy
  • coronavirus
03

In context

COVID-19

7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 4,100 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

European University of Madrid is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Experimental groupe

    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

  • Other
    control groupe

    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

  • OtherChest physiotherapy post-covid19

    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.

06

What researchers measure

Primary outcomes

  1. 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".

    Time frame: 1 week

  2. 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".

    Time frame: 4 week

  3. 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

    Time frame: 5 minutes before each session

  4. 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

    Time frame: 5 minutes after each session

  5. Respiratory rate

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

    Time frame: 5 minutes before each session

  6. Respiratory rate

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

    Time frame: 5 minutes after each session

  7. 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.

    Time frame: 1 week

  8. 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.

    Time frame: 4 week

  9. Anxiety

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

    Time frame: 1 week

  10. Anxiety

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

    Time frame: 4 week

  11. Level oxigen %

    pulxe-oximetry, the patient is sitting at rest

    Time frame: 1 week

  12. Level oxigen %

    pulxe-oximetry, the patient is sitting at rest

    Time frame: 4 week

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04678700
Lead sponsor
European University of Madrid
Responsible party
Marta de la Plaza (Physiotherapy teacher, PH student, European University of Madrid) — Principal investigator
First posted
Dec 22, 2020
Start date
Mar 1, 2021 (estimated)
Primary completion
Jun 1, 2021 (estimated)
Completion
Aug 1, 2021 (estimated)
Last update
Feb 3, 2021

Study contacts

Marta de la plaza, IP
Contact
marta_delaplaza@hotmail.com
0034659432984
Marta de la plaza, IP
Contact
marta_delaplaza@hotmail.com
Marta de la plaza
principal investigator · European University of Madrid

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion