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Completed

NCT Number: NCT03947112

Physical Activity Level of Norwegian Boys with Duchenne Muscular Dystrophy

The aim of this population based study is to examine, quantify and describe physical activity level in Norwegian boys with DMD, and to compare the level of physical activity level between boys with DMD and age matched healthy boys. A co-project will validate ActiGraph accelerometry to measure physical activity in boys with DMD.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

About this study

International guidelines recommend regular physical activity for boys with DMD, and participation in physical activity plays a key role in the management. Paradoxically, patients with severe neuromuscular disease like DMD, have considerable limitations to participate in such activities. Limitation may be muscle weakness, pain, fatigue, reduced mobility and overall function, and also limited knowledge of physical activity benefits among health care personnel. Limited participation leads to a sedentary lifestyle, and gradual under-use of still functioning muscles may cause secondary deterioration in DMD.

The current physical activity level amongst Norwegian DMD's are unknown, and physical activity registration and self-reported questionnaire will be examined in this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Boys with conclusive diagnosis of Duchenne Muscular disease, attending Norwegian pediatric rehabilitation clinics.
  • Signed written consent
  • Able to answer questionnaires with help from parents, care giver(s) or health care professional with regular follow up of the participants.

Exclusion criteria

  • Lack of consent.
  • Language difficulties
  • Cognitive dysfunction or mental retardation leading to difficulties in answering the questionnaires adequately

Treatment and study plan

Physical activity registration

Behavioral

At start, participants and parents fills out a Self-report questionnaire and the UngKan-3 Questionnaire, before a seven day physical activity registration takes place by use og ActiGraph. A physical activity diary are filled out every evening while the physical activity registration takes places.

Other names: Self-report Questionnaire, Physical activity diary, UngKan-3 Questionnaire

Primary outcomes

  1. Physical activity registration

    Time frame: Seven days

    An Actigraph will be provided and worn at pre set time frame (Seven days including weekend). Data extracted are counts per minutes, and are measurements of movement performed in both vertical and horizontal axis. The counts will be used to quantify the time the participant is inactive, low, moderate and / or in vigorous physical active.

Secondary outcomes

  1. Leisure time physical activity

    Time frame: Day 1

    The UngKan-3 questionnaire is a self-reported/parent-reported instrument, developed to measure leisure time physical activity, diet, media habits and sleep routine. The questionnaire is former used in a national cross-sectional survey amongst Norwegian school students, developed by the Norwegian School of Sport Sciences and Norwegian Institute of Public Health.

  2. Self-Reported Questionnaire

    Time frame: Day 1

    Self-administrated questionnaire developed to describe participants function, on-going treatment, movement aid, types of physical activities

Other outcomes

  1. Physical Activity diary

    Time frame: Day 1

    During physical activity registration with use of ActiGraph monitor, the participants and parents are asked to fill out a diary, describing type of physical activity been performed, for how long the physical activity was performed, how tired the participants became, and how did the participant enjoy the activity being performed. In addition the participants is asked to give a summary of the week regarding to name the most enjoyable activity this week and the reason why, and to describe if there occurred something unusual that increased or decreased their physical activity level more than regular.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Norwegian School of Sport Sciences
  • Oslo University Hospital

Registry information

Official study title

Physical Activity Level of Norwegian Boys with Duchenne Muscular Dystrophy - a Cross Sectional Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 13, 2019
Registry last updated
Mar 5, 2025

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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