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

NCT ID: NCT04678700

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-08-01

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

Conditions

Covid19- Coronavirus- Sars-cov-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chest physiotherapy post-covid19

Intervention Type: OTHER

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.

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.

Group Type: OTHER

Chest physiotherapy post-covid19

Intervention Type: OTHER

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.

Interventions

Chest 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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European University of Madrid

OTHER

Sponsor Role: lead

Responsible Party

Marta de la Plaza

Physiotherapy teacher, PH student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta de la plaza

Role: PRINCIPAL_INVESTIGATOR

European University of Madrid

Locations

Marta de la plaza

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Marta de la plaza, IP

Role: CONTACT

marta_delaplaza@hotmail.com

0034659432984

Marta de la plaza, IP

Role: CONTACT

marta_delaplaza@hotmail.com

Facility Contacts

Marta de la plaza, IP

Role: primary

marta_delaplaza@hotmail.com

659432984

Other Identifiers

20/139

Identifier Type: -

Identifier Source: org_study_id