Clinical trial NCT03947112: Physical Activity Level of Norwegian Boys with Duchenne Muscular Dystrophy
Official title: Physical Activity Level of Norwegian Boys with Duchenne Muscular Dystrophy - a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Keywords: Physical activity level
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
name: Oslo University Hospital
First posted: 2019-05-13
Enrollment: 28
Sex: MALE
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be requited from all the Norwegian regional pediatric rehabilitation centre's out patient clinics. Verbal and written information about the study will be provided if inclution criteria to be met.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity registration
timeFrame: Seven days
Secondary outcomes:
measure: Leisure time physical activity
timeFrame: Day 1
measure: Self-Reported Questionnaire
timeFrame: Day 1
Other outcomes:
measure: Physical Activity diary
timeFrame: Day 1
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hordaland
Study officials:
affiliation: Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway
name: Tiina M Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heutinck L, Kampen NV, Jansen M, Groot IJ. Physical Activity in Boys With Duchenne Muscular Dystrophy Is Lower and Less Demanding Compared to Healthy Boys. J Child Neurol. 2017 Apr;32(5):450-457. doi: 10.1177/0883073816685506. Epub 2017 Jan 23.
citation: Birnkrant DJ, Bushby K, Bann CM, Apkon SD, Blackwell A, Brumbaugh D, Case LE, Clemens PR, Hadjiyannakis S, Pandya S, Street N, Tomezsko J, Wagner KR, Ward LM, Weber DR; DMD Care Considerations Working Group. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. Lancet Neurol. 2018 Mar;17(3):251-267. doi: 10.1016/S1474-4422(18)30024-3. Epub 2018 Feb 3.