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Aerobic Exercise in Duchenne Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT04173234
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Numan Bulut, Hacettepe University

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 compare with children with DMD and healthy peers in terms of muscle architectural properties and motor functions, and investigate the effects of aerobic training on these parameters in children with DMD. Twenty children with DMD and 10 healthy peers will be included in the study. 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.

Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Other: Aerobic Training Other: Home exercise program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect on Muscle Architecture Properties and Motor Functions of Aerobic Training in Children With Duchenne Muscle Dystrophy
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : April 15, 2020


Arm Intervention/treatment
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
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: 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.

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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Assessment of muscle activation with surface Electromyography [ Time Frame: 30 minutes ]
    Maximal voluntary isometric contraction of bilateral vastus lateralis and medial gastrocnemius was recorded in manual muscle test position as microvolt. In the normalization process, the average of the EMG signal amplitude of standing was divided by the MVIC value for each muscle of interest. The muscle activation levels, expressed as a percentage of MVIC (MVIC%).

  2. Assessment of Motor Function by Motor Function Measure (MFM) [ Time Frame: 30 minutes ]
    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.)

  3. Evaluation Motor Performance with Timed Functional Test and Six minute walk test [ Time Frame: 20 minutes ]
    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.

  4. Shortening assessment of trunk and lower extremity muscles with goniometric measurement and tape [ Time Frame: 20 minutes ]
    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.



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Because DMD is X linked recessive disorder, this disorder is seen in male.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 5-12 years
  • Male

Exclusion Criteria:

  • having any injury or surgery of the lower extremity
  • having systemic and metabolic disease
  • having behavioral and cognitive problems that prevent consistence to guidelines given

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173234


Contacts
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Contact: Numan Bulut, MSc +905550058557 numanbulut@hacettepe.edu.tr

Locations
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Turkey
Hacettepe University, Faculty of Physical Therapy and Rehabilitation Recruiting
Ankara, Altındağ, Turkey, 06100
Contact: Ayşe Karaduman, Prof    +905326754103    aykaradu@hacettepe.edu.tr   
Sponsors and Collaborators
Hacettepe University
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Responsible Party: Numan Bulut, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier: NCT04173234    
Other Study ID Numbers: KA-19022
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Numan Bulut, Hacettepe University:
Duchenne Muscular Dystrophy
Aerobic Training
Ultrasonography
Motor Function
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked