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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Zdenek Svoboda, Assoc.Prof. contact

+420585636414

zdenek.svoboda@upol.cz

Martin Dvoracek, MSc. contact

+420604585149

martin.dvoracek01@upol.cz

Czechia1 site, 1 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

    Recruiting

Other trials in Czechia

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:

  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.
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 groups in NCT05533151
Study groupRoleWhat they receive
Bronchial asthmaExperimentalThis group envolves parients suffering from bronchial asthma.
Receives: Device: Respiratory muscle training
Interstitial lung diseasesExperimentalThis group envolves parients suffering from interstitial lung disease.
Receives: Device: Respiratory muscle training
Lung transplantationExperimentalThis 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.

  1. 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

  2. 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.

  1. First posted8 Sep 2022
  2. Study start1 Jul 2022
  3. Primary completion31 Jan 2023 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

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)
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

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.

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