Covid19- Coronavirus- Sars-cov-2NCT04678700
Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance
A study testing Chest physiotherapy post-covid19 in people with Covid19- Coronavirus- Sars-cov-2, run by European University of Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19- Coronavirus- Sars-cov-2
- What is being tested?
- Chest physiotherapy post-covid19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Marta de la plaza, IP contact
Spain1 site, 1 recruiting
- Recruiting
Marta de la plaza
Madrid, 28670
Marta de la plaza, IP, 659432984, marta_delaplaza@hotmail.com
About this study
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
- Conditions
- Covid19- Coronavirus- Sars-cov-2
- Being tested
- Chest physiotherapy post-covid19
- Keywords
- chest physiotherapy, covid19, pulmonary rehabilitation covid19, physical therapy, coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapy post-covid19Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Chest physiotherapy post-covid19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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
Measured: 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
Measured: 5 minutes after each session
Respiratory rate
breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.
Measured: 5 minutes before each session
Respiratory rate
breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.
Measured: 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.
Measured: 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.
Measured: 4 week
Anxiety
STAI, questionary of anxiety, we will take before the first session and at the end of the last session
Measured: 1 week
Anxiety
STAI, questionary of anxiety, we will take before the first session and at the end of the last session
Measured: 4 week
Level oxigen %
pulxe-oximetry, the patient is sitting at rest
Measured: 1 week
Level oxigen %
pulxe-oximetry, the patient is sitting at rest
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19- Coronavirus- Sars-cov-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta de la Plaza, European University of Madrid
- Investigators
- Marta de la plaza, Principal investigator, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678700
- Sponsor's protocol ID
- 20/139
- Status last verified
- Dec 2020
- First submitted
- 12 Dec 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance
- ClinicalTrials.gov ID
- NCT04678700
- Acronym / sponsor ID
- 20/139
- Conditions
- Covid19- Coronavirus- Sars-cov-2
- Keywords
- chest physiotherapy, covid19, pulmonary rehabilitation covid19, physical therapy, coronavirus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- European University of MadridUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental groupe | Experimental | Other: Chest physiotherapy post-covid19Intervention; 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. |
| control groupe | Other | Other: Chest physiotherapy post-covid19The 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest physiotherapy post-covid19The 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. | Other | Experimental groupe, control groupe |
Primary outcome
Euroqol-5d european quality of life-5 dimensions
Time frame: 1 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".
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 before 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
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
Respiratory rate
Time frame: 5 minutes before each session
breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.
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.
Effort dysnea Scale
Time frame: 1 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.
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.
Anxiety
Time frame: 1 week
STAI, questionary of anxiety, we will take before the first session and at the end of the last session
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: 1 week
pulxe-oximetry, the patient is sitting at rest
Level oxigen %
Time frame: 4 week
pulxe-oximetry, the patient is sitting at rest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta de la plaza, IP contact
Marta de la plaza principal investigator
European University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy post-covid19 in people with Covid19- Coronavirus- Sars-cov-2, run by European University of Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta de la plaza, IP (0034659432984, marta_delaplaza@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Euroqol-5d european quality of life-5 dimensions (time frame: 1 week). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.