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Clinical Trials/NCT04173234
NCT04173234CompletedNot Applicable

The Effect on Muscle Architecture Properties and Motor Functions of Aerobic Training in Children With Duchenne Muscle Dystrophy

Hacettepe University1 site in 1 country19 target enrollmentStarted: April 11, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
1
Primary Endpoint
Evaluation of Muscle Thickness, Fascicle Length, Pennation Angle with Ultrasonography

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
5 Years to 12 Years (Child)
Sex
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

  • •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.

Arms & Interventions

Treatment Group

Experimental

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.

Intervention: Aerobic Training (Other)

Treatment Group

Experimental

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.

Intervention: Home exercise program (Other)

Control Group

Active Comparator

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.

Intervention: Home exercise program (Other)

Outcomes

Primary Outcomes

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

Time Frame: 10 minutes

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.

Secondary Outcomes

  • Assessment of Motor Function by Motor Function Measure (MFM)(30 minutes)
  • Evaluation Motor Performance with Timed Functional Test and Six minute walk test(20 minutes)
  • Shortening assessment of trunk and lower extremity muscles with goniometric measurement and tape(20 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Numan Bulut

Research Assistant

Hacettepe University

Study Sites (1)

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