Aerobic Exercise in Duchenne Muscular Dystrophy

NCT04173234 | Completed DMC

• 1 other identifier: KA-19022
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne Muscular Dystrophy; Aerobic Training; Ultrasonography; Motor Function

Outcome Measures

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.

  10 minutes

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Other: Aerobic Training; Other: Home exercise program

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.

Other: Home exercise program

Interventions

Aerobic Training OTHER

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.

Treatment Group

Home exercise program OTHER

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.

Control Group; Treatment Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Gender Eligibility Details: Because DMD is X linked recessive disorder, this disorder is seen in male.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: November 21, 2019
• Study Start: April 11, 2019
• Primary Completion: August 15, 2020
• Study Completion: December 15, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)