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Completed

NCT Number: NCT03319030

Aerobic Exercise in Boys With Duchenne Muscular Dystrophy (DMD)

This research study wants to learn more about Duchenne Muscular Dystrophy (DMD) and exercise. Today it is unknown how exercising impacts boys with DMD. The investigators believe that increasing activity and aerobic exercise may help with heart, lung, and muscle function. The investigators are hoping to compare physical strength and blood samples of boys with DMD to see if there are any differences between kids who exercised more as a child versus those who didn't.

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Key information

Conditions

Duchenne Muscular Dystrophy Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Motor Activity Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

2 year–17 year

Sex eligibility

Male

Study type

Observational

Primary location

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

Recently, the American Academy of Neurology released new guidelines for children with Duchenne Muscular Dystrophy (DMD) with an updated recommendation to include moderate aerobic exercise. Historically, children with DMD were advised to not exercise as it was thought to accelerate muscle loss. Today, there is new data suggesting that moderate aerobic exercise that does not strain muscle may be beneficial and improve a child's quality of life with regard to heart disease, fatigue, and other factors of overall health. Although it is expected that children who exercise will experience health benefits, there is no scientific evidence indicating a positive or negative effect in a DMD population.

This study is trying to understand the role of aerobic exercise in boys with DMD and how it may impact heart, muscle, and lung function using newly identified biomarkers. The goal is to correlate increased aerobic exercise with improved functional outcomes and changes in biomarkers.

The data collected from this study will allow future development and implementation of an innovative and disease-specific home aerobic exercise program that in the future will be recommended to families of children with DMD.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 2-17 years old with a confirmed diagnosis of DMD. Has an appointment in MDA clinic at the Ann & Robert H. Lurie Children's Hospital of Chicago.

Exclusion criteria

  • Is less than two years old and does not have a confirmed diagnosis of DMD.

Treatment and study plan

Primary outcomes

  1. microRNA levels

    Time frame: Baseline only

    Understanding if there are any differences in microRNA's in boys who are more active versus those who are not.

Secondary outcomes

  1. Physical therapy assessment - 10 meter run test

    Time frame: Baseline only

    Time in seconds that it takes a participant to run 10 meters.

  2. Physical therapy assessment - North Star Ambulatory Assessment

    Time frame: Baseline only

    Comparing a standardized test for ambulatory boys with DMD that gives a score out of 34 total points and microRNA levels.

  3. Physical therapy assessment - time to standing from supine

    Time frame: Baseline only

    Time in seconds that it takes a participant to stand from a supine position.

  4. Cardiac Assessments: Electrocardiogram (ECG)

    Time frame: Baseline only

    Comparing heart rate (BPM), PR interval (msec), QRS (msec), and QT intervals (msec) to microRNA levels.

  5. Cardiac Assessments: Echocardiogram (ECHO)

    Time frame: Baseline only

    Comparing ejection fraction (%) and other Left Ventricle systolic and diastolic metrics (cm) and microRNA levels.

  6. Questionnaire: Pediatric Quality of Life: Neuromuscular module

    Time frame: Baseline only

    To see if there is any correlation between Quality of Life scores (range from 0 to 100) and microRNA levels. Increased scores indicate a higher quality of life.

  7. Questionnaire: Physical Function Survey

    Time frame: Baseline only

    To see if there is any correlation between scores of functional ability (with a range from 0 to 106) and microRNA levels. Higher physical function function scores indicate increased strength.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Evaluating the Impact of Aerobic Exercise in Boys With Duchenne Muscular Dystrophy (DMD)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2017
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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