TelerehabilitationNCT05533151
The Influence of Telerehabilitation Focused on Respiratory Muscle Training
A study testing Respiratory muscle training in people with Telerehabilitation, run by Palacky University at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telerehabilitation
- What is being tested?
- Respiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of bronchial asthma
- diagnosis of interstitial lung disease
- post-lung-transplantation statust
- stable disease status
- no exacerbation within last 2 months.
Who cannot join
- serious comorbidities (rheumatological, neurological, psychiatric, etc.)
- other respiratory lung disease than the specified ones
- contraindication for respiratory muscle training.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Faculty of Physical Culture, Palacky University Olomouc
Olomouc, 77111
Zdenek Svoboda, Ph.D., +420585636414, zdenek.svoboda@upol.cz
Miroslav Janura, Prof., +420585636400, miroslav.janura@upol.cz
About this study
Official title: The Influence of Telerehabilitation Focused on Respiratory Muscle Training on the Functional Status of Patients With the Respiratory System Diseases
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.
Read the 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:
- 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.
- Conditions
- Telerehabilitation
- Being tested
- Respiratory muscle training
- Keywords
- Respiratory muscle training, Pulmonary rehabilitation, Telerehabilitation, Respiratory system disease, Physical activity, Functional status, Exercise tolerance, Spirometry
- Medical subject headings
- Respiratory Tract Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bronchial asthma | Experimental | This group envolves parients suffering from bronchial asthma. Receives: Device: Respiratory muscle training |
| Interstitial lung diseases | Experimental | This group envolves parients suffering from interstitial lung disease. Receives: Device: Respiratory muscle training |
| Lung transplantation | Experimental | This group envolves parients after lung transplantation done for a pulmonary disease. Receives: Device: Respiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
The adherence to respiratory muscle training
The frequency (number) of the smartphone App use is the main determinant for the adherence evaluation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Jul 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zdenek Svoboda, Palacky University
- Investigators
- Katerina Raisova, Assoc.Prof., Study director, Palacký University, Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533151
- Sponsor's protocol ID
- DSGC-2021-0156
- Status last verified
- Sep 2022
- First submitted
- 25 Jul 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Telerehabilitation Focused on Respiratory Muscle Training on the Functional Status of Patients With the Respiratory System Diseases
- ClinicalTrials.gov ID
- NCT05533151
- Acronym / sponsor ID
- DSGC-2021-0156
- Conditions
- Telerehabilitation
- Keywords
- Respiratory muscle training, Pulmonary rehabilitation, Telerehabilitation, Respiratory system disease, Physical activity, Functional status, Exercise tolerance, Spirometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bronchial asthma | Experimental | Device: Respiratory muscle trainingThis group envolves parients suffering from bronchial asthma. |
| Interstitial lung diseases | Experimental | Device: Respiratory muscle trainingThis group envolves parients suffering from interstitial lung disease. |
| Lung transplantation | Experimental | Device: Respiratory muscle trainingThis group envolves parients after lung transplantation done for a pulmonary disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of bronchial asthma
- diagnosis of interstitial lung disease
- post-lung-transplantation statust
- stable disease status
- no exacerbation within last 2 months.
Key exclusion criteria (3 listed)
- serious comorbidities (rheumatological, neurological, psychiatric, etc.)
- other respiratory lung disease than the specified ones
- contraindication for respiratory muscle training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory muscle trainingAll 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. | Device | Bronchial asthma, Interstitial lung diseases, Lung transplantation |
Primary outcome
Respiratory muscle strength
Time frame: 6 weeks
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
Time frame: 6 weeks
The frequency (number) of the smartphone App use is the main determinant for the adherence evaluation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katerina Raisova, Assoc.Prof. study director
Palacký University, Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle training in people with Telerehabilitation, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zdenek Svoboda, Assoc.Prof. (+420585636414, zdenek.svoboda@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.