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CompletedNCT04173234Updated Sep 30, 2021

Aerobic Exercise in Duchenne Muscular Dystrophy

An interventional study of Aerobic Training and Home exercise program in Duchenne Muscular Dystrophy, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to male participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-09-30.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
Male
01

Study summary

Duchenne Muscular Dystrophy (DMD) is the most common neuromuscular disease in childhood with an estimate incidence of 1 in 3500 to 5000 male births. The effect of aerobic training on muscle architectural properties and motor functions such as muscle activation is not clear in DMD. The aim of this study is to investigate the effects of aerobic training on these parameters in children with DMD. Twenty children with DMD included in the study will be divided into two groups as home program and home program+aerobic training with block randomization method. Home program including stretching, respiratory, range of motion and mild resistance exercise with body weight will be asked to apply 3-5 days a week for 12 weeks, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period. Muscle architectural properties, muscle strength, muscle activation and motor function will be assessed with ultrasonographic, hand-held myometry, surface EMG and Motor Function Measure, consecutively. Assessments will be applied at pre-training and after 12 weeks of training.

02

Conditions studied

  • Duchenne Muscular Dystrophy

Keywords

  • Duchenne Muscular Dystrophy
  • Aerobic Training
  • Ultrasonography
  • Motor Function
03

In context

Muscular Dystrophies

548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.

This study's enrollment of 19 is below the median of 24 across 344 interventional studies indexed under Muscular Dystrophies.

Browse Muscular Dystrophies studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Children had diagnosis of DMD confirmed by genetic analysis,
  • Children had functional level of Grade 1 and 2 according to Vignos Scale.

Exclusion criteria

Exclusion criteria:

  • Children had undergone any surgery or suffered injury of the lower limbs,
  • Children had comorbid disease
  • Children were applied regular aerobic training in last 6 months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Treatment Group

    Home exercise program Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week. Also, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period to children in treatment group.

    Other: Aerobic Training · Other: Home exercise program

  • Active comparator
    Control Group

    Home exercise program Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do this program for 5 days a week.

    Other: Home exercise program

Interventions

  • OtherAerobic Training

    Aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period to children in treatment group.

  • OtherHome exercise program

    Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.

06

What researchers measure

Primary outcomes

  1. Evaluation of Muscle Thickness, Fascicle Length, Pennation Angle with Ultrasonography

    Bilateral Vastus Lateralis and Medial Gastrocnemius US evaluations were performed with use of a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). Children were positioned supine with their legs extended and their muscles relaxed for vastus lateralis.Children were positioned prone position with their legs and their muscles relaxed for medial gastrocnemius. While Muscle Thickness and Fascicle Length would be expressed as centimeters, pennation angle would be angularly indicated.

    Time frame: 10 minutes

Secondary outcomes

  1. Assessment of Motor Function by Motor Function Measure (MFM)

    The total scores of the MFM test were determined in three motor function domains: D1 (Standing Position \& Transfers), D2 (Axial and Proximal Motor Function) and D3 (Distal Motor Function) (scored between 0-96 points, low score indicate low performance.)

    Time frame: 30 minutes

  2. Evaluation Motor Performance with Timed Functional Test and Six minute walk test

    Timed function tests included time taken to stand from a supine position, time taken to run/walk 10 m, time taken to climb 4 standard-sized stairs, time taken to descend 4 standard-sized stairs and time taken to stand one leg stance (both leg).Participants were instructed to travel as far and as fast as possible in six minutes on 25 meter-indoor course.

    Time frame: 20 minutes

  3. Shortening assessment of trunk and lower extremity muscles with goniometric measurement and tape

    Assessment of back extensors, hip flexors, hamstring, quadriceps and gastrocnemius muscles. For assessment back extensors, The child was placed in the supine position with his knee fixed at a neutral position, and then shortening was evaluated by having bilateral hip flexion made. For hip flexor, The child was placed in the supine position with his knee fixed at a neutral position, and he was then evaluated by having one leg hip flexion made. Hamstring shortening was measured in a supine position with the hip flexed at 90° and the opposite knee and hip were placed in an extended position. Quadriceps shortening was assessed in a prone position and then by bending knee. For gastrocnemius muscle, the child was placed in a supine position and asked to perform passive ankle dorsiflexion while the knee was extended.

    Time frame: 20 minutes

07

Study locations

1 site
  • Hacettepe University, Faculty of Physical Therapy and Rehabilitation
    Ankara, Altındağ 06100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04173234
Lead sponsor
Hacettepe University
Responsible party
Numan Bulut (Research Assistant, Hacettepe University) — Principal investigator
First posted
Nov 21, 2019
Start date
Apr 11, 2019
Primary completion
Aug 15, 2020
Completion
Dec 15, 2020
Last update
Sep 30, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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