Investigation of the Effects of Functional Inspiratory Muscle Training Applied With Tele-Rehabilitation on Respiratory and Functional Parameters and Quality of Life in Children With Duchenne Muscular Dystrophy: Randomized Controlled Study

NCT07172737 | Completed DMC

• 1 other identifier: 0451
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Dushenne muscular dystrophy (DMD), which is characterized by the deficiency of dystrophin protein, prevents the muscle from maintaining its normal activity, causing progressive damage to the heart, respiratory muscles and skeletal muscles. When studies on patients with DMD are examined in the literature, very few studies are found investigating the effectiveness of pure respiratory muscle training, while no studies are found investigating the effectiveness of functional respiratory muscle training.

Conditions

Duchenne Muscular Dystrophy

Keywords

respiratory muscles; tele rehabilitation

Outcome Measures

Primary Outcomes (2)

• Respiratory Muscle Strenght Test

  Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements were used to assess respiratory muscles. MIP and MEP represent the intraoral pressures measured under closed airway conditions during maximal inspiration and expiration, respectively. In this study, these measurements were performed using an intraoral pressure measurement device (Pony FX, COSMED Inc., Rome, Italy) to determine respiratory muscle strength. During the test, for MIP measurement, participants were instructed to perform a maximal inspiration for 1-3 seconds following a maximal expiration while the airway was occluded with a valve. For MEP measurement, after a maximal inspiration, the airway was occluded and participants were asked to perform a maximal expiration for 1-3 seconds. Among the three trials conducted for each parameter, the highest value was recorded.

  eight week

• Respiratory Function Test

  The measurements were performed using a portable spirometer. In the spirometric assessment, forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), the FEV₁/FVC ratio, and peak expiratory flow (PEF) parameters were examined, and these values were recorded as percentages of the predicted values according to age, height, body weight, and sex.

  eight week

Secondary Outcomes (2)

• Modified Medical Research Council (mMRC) Dyspnea Scale

  eight weeks

• Six-Minute Walk Test

  eight weeks

Other Outcomes (2)

• Brooke Scale

  Baseline

• Vignos Scale

  Baseline

Study Arms (3)

İntervetion Group 1

EXPERIMENTAL

IMT will be performed.

Other: Respiratory Muscle Training

İntervetion group 2

EXPERIMENTAL

Functional IMT will be performed.

Other: Respiratory Muscle Training

Control Group

NO INTERVENTION

Routine treatment will continue.

Interventions

Respiratory Muscle Training OTHER

Respiratory Muscle Training with Telerehabilitation

İntervetion Group 1; İntervetion group 2

Eligibility Criteria

• Age: 5 Years - 17 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being between the ages of 5-17
• Ambulate
• Having a diagnosis of DMD based on the presence of clinical symptoms, genetic testing or muscle biopsy results
• Having the ability to perform respiratory function tests
• Being able to cooperate with the physiotherapist

You may not qualify if:

• Having severe upper extremity contracture or serious systemic disease that would prevent our evaluation
• Having a respiratory tract infection in the last 3 months
• Having had an injury or surgery on both upper extremities in the last 6 months

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Tepecik training and research hospital

Izmir, Konak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist physiotherapist

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: September 15, 2025
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)