Physical Activity Level of Norwegian Boys with Duchenne Muscular Dystrophy

NCT03947112 | Completed

• 1 other identifier: 2019/260
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Duchenne Muscular Dystrophy

Keywords

Physical activity level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Leisure time physical activity

  Day 1

• Self-Reported Questionnaire

  Day 1

Other Outcomes (1)

• Physical Activity diary

  Day 1

Study Arms (1)

Norwegian population with Duchenne Muscular Dystrophy (DMD)

Boys with DMD.

Behavioral: Physical activity registration

Interventions

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.

Also known as: Self-report Questionnaire, Physical activity diary, UngKan-3 Questionnaire

Norwegian population with Duchenne Muscular Dystrophy (DMD)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Gender Eligibility Details: DMD is X-linked disease
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Norwegian School of Sport Sciences: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Related Publications (2)

• 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.

  PMID: 28112012 BACKGROUND

• 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.

  PMID: 29395989 BACKGROUND

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

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

Study Officials

• Tiina M Andersen, PhD

  Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: August 20, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 5, 2025

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)