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Aerobic Exercise in Duchenne Muscular Dystrophy

Primary Purpose

Duchenne Muscular Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic Training
Home exercise program
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duchenne Muscular Dystrophy focused on measuring Duchenne Muscular Dystrophy, Aerobic Training, Ultrasonography, Motor Function

Eligibility Criteria

5 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.)
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.
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.

Full Information

First Posted
May 28, 2019
Last Updated
September 29, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04173234
Brief Title
Aerobic Exercise in Duchenne Muscular Dystrophy
Official Title
The Effect on Muscle Architecture Properties and Motor Functions of Aerobic Training in Children With Duchenne Muscle Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy
Keywords
Duchenne Muscular Dystrophy, Aerobic Training, Ultrasonography, Motor Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Aerobic Training
Intervention Description
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 Type
Other
Intervention Name(s)
Home exercise program
Intervention Description
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 Measure Information:
Title
Evaluation of Muscle Thickness, Fascicle Length, Pennation Angle with Ultrasonography
Description
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 Outcome Measure Information:
Title
Assessment of Motor Function by Motor Function Measure (MFM)
Description
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
Title
Evaluation Motor Performance with Timed Functional Test and Six minute walk test
Description
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
Title
Shortening assessment of trunk and lower extremity muscles with goniometric measurement and tape
Description
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

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Because DMD is X linked recessive disorder, this disorder is seen in male.
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Aerobic Exercise in Duchenne Muscular Dystrophy

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