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The Influence of Telerehabilitation Focused on Respiratory Muscle Training

Primary Purpose

Telerehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Respiratory muscle training
Sponsored by
Palacky University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telerehabilitation focused on measuring Respiratory muscle training, Pulmonary rehabilitation, Telerehabilitation, Respiratory system disease, Physical activity, Functional status, Exercise tolerance, Spirometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Culture, Palacky University OlomoucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Bronchial asthma

Interstitial lung diseases

Lung transplantation

Arm Description

This group envolves parients suffering from bronchial asthma.

This group envolves parients suffering from interstitial lung disease.

This group envolves parients after lung transplantation done for a pulmonary disease.

Outcomes

Primary Outcome Measures

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.
The adherence to respiratory muscle training
The frequency (number) of the smartphone App use is the main determinant for the adherence evaluation.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2022
Last Updated
September 5, 2022
Sponsor
Palacky University
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1. Study Identification

Unique Protocol Identification Number
NCT05533151
Brief Title
The Influence of Telerehabilitation Focused on Respiratory Muscle Training
Official Title
The Influence of Telerehabilitation Focused on Respiratory Muscle Training on the Functional Status of Patients With the Respiratory System Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palacky University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation
Keywords
Respiratory muscle training, Pulmonary rehabilitation, Telerehabilitation, Respiratory system disease, Physical activity, Functional status, Exercise tolerance, Spirometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bronchial asthma
Arm Type
Experimental
Arm Description
This group envolves parients suffering from bronchial asthma.
Arm Title
Interstitial lung diseases
Arm Type
Experimental
Arm Description
This group envolves parients suffering from interstitial lung disease.
Arm Title
Lung transplantation
Arm Type
Experimental
Arm Description
This group envolves parients after lung transplantation done for a pulmonary disease.
Intervention Type
Device
Intervention Name(s)
Respiratory muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
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.
Time Frame
6 weeks
Title
The adherence to respiratory muscle training
Description
The frequency (number) of the smartphone App use is the main determinant for the adherence evaluation.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zdenek Svoboda, Assoc.Prof.
Phone
+420585636414
Email
zdenek.svoboda@upol.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Dvoracek, MSc.
Phone
+420604585149
Email
martin.dvoracek01@upol.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katerina Raisova, Assoc.Prof.
Organizational Affiliation
Palacký University Olomouc
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Culture, Palacky University Olomouc
City
Olomouc
ZIP/Postal Code
77111
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zdenek Svoboda, Ph.D.
Phone
+420585636414
Email
zdenek.svoboda@upol.cz
First Name & Middle Initial & Last Name & Degree
Miroslav Janura, Prof.
Phone
+420585636400
Email
miroslav.janura@upol.cz
First Name & Middle Initial & Last Name & Degree
Martin Dvoracek, MSc.
First Name & Middle Initial & Last Name & Degree
Pavla Horova, MSc.
First Name & Middle Initial & Last Name & Degree
Tamara Zlamalova, MSc.
First Name & Middle Initial & Last Name & Degree
Tereza Kopecka, MSc.

12. IPD Sharing Statement

Plan to Share IPD
No

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The Influence of Telerehabilitation Focused on Respiratory Muscle Training

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