Clinical trial NCT04678700: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19- Coronavirus- Sars-cov-2
Keywords: chest physiotherapy
covid19
pulmonary rehabilitation covid19
physical therapy
coronavirus
Lead sponsor: European University of Madrid
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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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)

Primary outcomes:
measure: Euroqol-5d european quality of life-5 dimensions
timeFrame: 1 week
measure: Euroqol-5d european quality of life-5 dimensions
timeFrame: 4 week
measure: Dysnea scale Borg
timeFrame: 5 minutes before each session
measure: Dysnea scale Borg
timeFrame: 5 minutes after each session
measure: Respiratory rate
timeFrame: 5 minutes before each session
measure: Respiratory rate
timeFrame: 5 minutes after each session
measure: Effort dysnea Scale
timeFrame: 1 week
measure: Effort dysnea Scale
timeFrame: 4 week
measure: Anxiety
timeFrame: 1 week
measure: Anxiety
timeFrame: 4 week
measure: Level oxigen %
timeFrame: 1 week
measure: Level oxigen %
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Marta de la plaza
Study officials:
affiliation: European University of Madrid
name: Marta de la plaza
role: PRINCIPAL_INVESTIGATOR
References: