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Completed

NCT Number: NCT07172737

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.

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Key information

Age range

5 year–17 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tepecik training and research hospital

Izmir, Konak, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

respiratory muscle training

Other

Respiratory Muscle Training with Telerehabilitation

Primary outcomes

  1. Respiratory Muscle Strenght Test

    Time frame: eight week

    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.

  2. Respiratory Function Test

    Time frame: eight week

    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.

Secondary outcomes

  1. Modified Medical Research Council (mMRC) Dyspnea Scale

    Time frame: eight weeks

    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.

  2. Six-Minute Walk Test

    Time frame: eight weeks

    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.

Other outcomes

  1. Brooke Scale

    Time frame: Baseline

    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).

  2. Vignos Scale

    Time frame: Baseline

    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).

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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