Covid19- Coronavirus- Sars-cov-2 Clinical Trial
Official title:
Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance
| NCT number | NCT04678700 |
| Other study ID # | 20/139 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 1, 2021 |
| Est. completion date | August 1, 2021 |
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | August 1, 2021 |
| Est. primary completion date | June 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Marta de la plaza | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| European University of Madrid |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Respiratory rate | breathing rate in one minute. The patient sitting upright takes the number of breaths per minute. | 5 minutes before each session | |
| Primary | Respiratory rate | breathing rate in one minute. The patient sitting upright takes the number of breaths per minute. | 5 minutes after each session | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Anxiety | STAI, questionary of anxiety, we will take before the first session and at the end of the last session | 1 week | |
| Primary | Anxiety | STAI, questionary of anxiety, we will take before the first session and at the end of the last session | 4 week | |
| Primary | Level oxigen % | pulxe-oximetry, the patient is sitting at rest | 1 week | |
| Primary | Level oxigen % | pulxe-oximetry, the patient is sitting at rest | 4 week |