Physical Activity Level of Norwegian Boys with Duchenne Muscular Dystrophy

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

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.

Study Overview

• Status: Completed
• Conditions: Duchenne Muscular Dystrophy
• Intervention / Treatment: Behavioral: Physical activity registration

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Norwegian population with Duchenne Muscular Dystrophy (DMD); Boys with DMD.

Behavioral: Physical activity registration; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity registration	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.	Seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leisure time physical activity	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.	Day 1
Self-Reported Questionnaire	Self-administrated questionnaire developed to describe participants function, on-going treatment, movement aid, types of physical activities	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity diary	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.	Day 1

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Oslo University Hospital; Norwegian School of Sport Sciences
• Investigators: Principal Investigator: Tiina M Andersen, PhD, Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Lancet Neurol. 2018 Jun;17(6):495. doi: 10.1016/S1474-4422(18)30125-X.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Physical activity level
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Muscular Disorders, Atrophic; Muscular Dystrophies; Muscular Dystrophy, Duchenne
• Other Study ID Numbers: 2019/260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No