Physical Activity Level of Norwegian Boys With Duchenne Muscular Dystrophy

study id #: NCT03947112

condition: Duchenne Muscular Dystrophy

status: not yet recruiting

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.

intervention: Physical activity registration

mechanism of action: No pharmaceutical intervention

results: https://clinicaltrials.gov/ct2/show/results/NCT03947112

last updated: June 03, 2019

start date: August 1, 2019

estimated completion: September 30, 2020

phase of development: N/A

size / enrollment: 90

study description:
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.

primary outcomes:

• 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:

• Physical Activity Questionnaire for children Score [ Time Frame: Day 1 ]
  The PAQ-C is a self-administrated, 7 day recall instrument, developed to assess general levels of physical activity throughout the elementary school year for students in grades 4 to 8 and approximately 8 to 14 years of age. The PAQ-C provides a summary physical activity score derived from nine items, each scored on a 5-point scale. The nine items are: Spare time activities, physical education, recess, lunch, right after school, evening, weekend, best description of physical activity during last seven days
  
• Self-Reported Questionnaire [ Time Frame: Day 1 ]
  Self-administrated questionnaire developed to describe participants function, on-going treatment, movement aid, types of physical activities

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

sponsor: Haukeland University Hospital

contacts: Stian Hammer MSc, +4790186485, stian.hammer@helse-bergen.no; Tiina M Andersen PhD, +47 55978486, tiina.andersen@helse-bergen.no

investigators: Tiina M Andersen, PhD

locations: Norway