The Influence of Telerehabilitation Focused on Respiratory Muscle Training

NCT05533151 | Unknown

• 1 other identifier: DSGC-2021-0156
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Telerehabilitation

Keywords

Respiratory muscle training; Pulmonary rehabilitation; Telerehabilitation; Respiratory system disease; Physical activity; Functional status; Exercise tolerance; Spirometry

Outcome Measures

Primary Outcomes (2)

• 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

• The adherence to respiratory muscle training

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

  6 weeks

Study Arms (3)

Bronchial asthma

EXPERIMENTAL

This group envolves parients suffering from bronchial asthma.

Device: Respiratory muscle training

Interstitial lung diseases

EXPERIMENTAL

This group envolves parients suffering from interstitial lung disease.

Device: Respiratory muscle training

Lung transplantation

EXPERIMENTAL

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

Device: Respiratory muscle training

Interventions

Respiratory muscle training DEVICE

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.

Bronchial asthma; Interstitial lung diseases; Lung transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of bronchial asthma
• diagnosis of interstitial lung disease
• post-lung-transplantation statust
• stable disease status
• no exacerbation within last 2 months.

You may not qualify if:

• serious comorbidities (rheumatological, neurological, psychiatric, etc.)
• other respiratory lung disease than the specified ones
• contraindication for respiratory muscle training.

Sponsors & Collaborators

• Palacky University: lead

Study Sites (1)

Faculty of Physical Culture, Palacky University Olomouc

Olomouc, 77111, Czechia

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Diseases; Motor Activity

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Katerina Raisova, Assoc.Prof.

  Palacký University, Olomouc

  STUDY DIRECTOR

Central Study Contacts

Zdenek Svoboda, Assoc.Prof.

CONTACT

+420585636414; zdenek.svoboda@upol.cz

Martin Dvoracek, MSc.

CONTACT

+420604585149; martin.dvoracek01@upol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Zdenek Svoboda, Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: September 8, 2022
• Study Start: July 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: June 1, 2023
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)