The Influence of Telerehabilitation Focused on Respiratory Muscle Training

Telerehabilitation Clinical Trial

Official title:

The Influence of Telerehabilitation Focused on Respiratory Muscle Training on the Functional Status of Patients With the Respiratory System Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533151
• Other study ID #: DSGC-2021-0156
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2022
• Source: Palacky University
• Contact: Zdenek Svoboda, Assoc.Prof.
• Phone: +420585636414
• Email: zdenek.svoboda[@]upol.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pulmonary rehabilitation, which includes respiratory muscle training, is effective in improving the functional status of patients with various types of the respiratory system diseases, including bronchial asthma, interstitial lung diseases or lung transplant patients.

However, availability of pulmonary rehabilitation is limited in the Czech Republic. Nowadays even more due to the Covid-19 pandemic. A suitable instrument of increasing its accessibility is telerehabilitation using modern technologies. The main goal of this project is to evaluate the patients' functional status after completing a standardized cycle of pulmonary rehabilitation focused on respiratory muscle training conducted as telerehabilitation sessions and compare the effect of this intervention with a different group of patients who will undergo an education session led by a trained physiotherapist followed by self-directed exercise according to an exercise brochure.

Description:

The study will include patients with the following respiratory system diseases: bronchial asthma, interstitial lung diseases (sarcoidosis, pulmonary fibrosis, etc.) and patients after lung transplantation enrolled in outpatient care by the attending physician.

All these patients must meet inclusion criteria, such as: stable disease status, no exacerbation within last 2 months. Patients with comorbidities (rheumatological, neurological, psychiatric, etc.) preventing them from being enrolled in a pulmonary rehabilitation program will be excluded from the study. All study participants will be divided into 3 groups according to their lung disease. Each group should contain 20 patients, who will be randomly split into an intervention and a control group of 10 patients each. The course of lung disease, its symptoms, medication, and the patient's functional status will be determined in detail. The following parameters will be objectively evaluated: lung function and respiratory muscle strength, exercise tolerance, chest expansion, dyspnoea, fatigue, anxiety and depression, quality of life in relation to lung disease and physical activity. The patients will be examined using spirometry, Modified Medical Research Council Dyspnea Scale, the Multidimensional Assessment of Fatigue Scale, self-report Beck Depression Inventory-II scale for adults and St. George's Respiratory Questionnaire examining the quality of life in relation to lung disease. Exercise tolerance testing will be performed through a 1-minute Sit-to-stand test. The level of physical activity will be examined using Axivity AX3 accelerometers, which the patient will wear for 7 days after the initial assessment, which will take place in one day. There will always be a long enough rest between examinations, so that fatigue cannot affect the course of the measurement. All assessments are non-invasive, and all the mentioned test methods are standardized and commonly used in patients with diseases of the respiratory system according to the recommendations of the Czech Pneumological and Phthisiological Society and the European Respiratory Society. All patients will be initially educated by a physiotherapist and instructed to independently perform the home exercise program including respiratory muscle training. This program will also include breathing exercises to correct the breathing pattern, exercises to strengthen the upper and lower limbs muscles, balance exercises and recommendations for endurance training. Respiratory muscle training will be performed using the Airofit PRO device. This breathing device can be set to a suitable resistance for both inhale and exhale to increase the strength of the inspiratory and expiratory muscles. Airofit PRO device can also be connected to an application in a smartphone, which records the ongoing results of the training as well as the frequency of the device use. This is a great starting point for its implementation within a telerehabilitation program, as well as for its self-directed use. The intervention group will perform the home exercise program independently with the use of an exercise brochure and at the same time with the support of telerehabilitation lessons with a physiotherapist twice a week via Zoom meeting. The control group will continue in a separate program according to the exercise brochure. To ensure a correct exercise performance all exercises in the exercise brochure will be individually practiced by a trained physiotherapist with each patient from both groups during the initial assessment. The assessment day will be divided into two parts:

1. all assessments in the morning; 2. exercise brochure introduction in the afternoon to avoid fatigue of patients. The final assessment will take place 6 weeks after the initial one. It will be exactly the same as the first one.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of bronchial asthma

• diagnosis of interstitial lung disease

• post-lung-transplantation statust

• stable disease status

• no exacerbation within last 2 months.

Exclusion Criteria:

• serious comorbidities (rheumatological, neurological, psychiatric, etc.)

• other respiratory lung disease than the specified ones

• contraindication for respiratory muscle training.

Related Conditions & MeSH terms

• Telerehabilitation

Intervention

Device:
• Respiratory muscle training
All patients will be initially educated by a physiotherapist and instructed to independently perform the home exercise program including respiratory muscle training. The training will be performed using the Airofit PRO device. This breathing training on a suitable resistance will be performed twice a day for 6 weeks. The intervention will be conducted under a researcher's supervision via smartphone App.

Locations

Country	Name	City	State
Czechia	Faculty of Physical Culture, Palacky University Olomouc	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle strength	Respiratory muscle strength (MIP = maximum inspiratory pressure, MEP = maximum expiratory pressure, P0.1 = airway occlusion pressure [kPa], TTmus = tension time index). Evaluation of the difference between respiraory muscle strength training with (intervention) and without (control) telerehabilitation support.	6 weeks
Primary	The adherence to respiratory muscle training	The frequency (number) of the smartphone App use is the main determinant for the adherence evaluation.	6 weeks