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

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.

Study Overview

• Status: Completed
• Conditions: Duchenne Muscular Dystrophy
• Intervention / Treatment: Other: Respiratory Muscle Training

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Konak
    • Izmir, Konak, Turkey (Türkiye)
      • Tepecik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: İntervetion Group 1; IMT will be performed.	Other: Respiratory Muscle Training; Respiratory Muscle Training with Telerehabilitation
Experimental: İntervetion group 2; Functional IMT will be performed.	Other: Respiratory Muscle Training; Respiratory Muscle Training with Telerehabilitation
No Intervention: Control Group; Routine treatment will continue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Medical Research Council (mMRC) Dyspnea Scale	This scale is a categorical instrument scored from 0 to 4 that assesses the level of breathlessness experienced by patients during daily life activities. Participants responded by selecting one of the five statements that best reflected the severity of their dyspnea.	eight weeks
Six-Minute Walk Test	The six-minute walk test, frequently used to evaluate physical functional capacity and endurance in neuromuscular diseases, is a submaximal test that measures the walking distance covered by patients over six minutes on a hard surface within a 30-meter corridor. Participants were instructed to walk at their own pace, with rest permitted during the six-minute period, and the total distance walked was recorded in meters.	eight weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brooke Scale	Upper extremity functions were scored on a scale ranging from 1 (able to abduct arms in a full circle) to 6 (no functional use of the hands).	Baseline
Vignos Scale	This scale was developed to classify lower extremity functions. Lower extremity functions were scored from 1 (able to walk and climb stairs without assistance) to 10 (confined to bed).	Baseline

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: September 8, 2025
• First Posted (Estimated): September 15, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: respiratory muscles; tele rehabilitation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Muscular Disorders, Atrophic; Muscular Dystrophies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Muscular Dystrophy, Duchenne; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Breathing Exercises
• Other Study ID Numbers: 0451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No