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Physical Activity Level of Norwegian Boys With Duchenne Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT03947112
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
Norwegian School of Sport Sciences
Oslo University Hospital
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease Intervention/treatment
Duchenne Muscular Dystrophy 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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Physical Activity Level of Norwegian Boys With Duchenne Muscular Dystrophy - a Cross Sectional Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020


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 PAQ-C, 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
  • Physical Activity Questionnaire for children (PAQ-C)




Primary Outcome Measures :
  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 Outcome Measures :
  1. 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

  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 Outcome Measures:
  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.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   DMD is X-linked disease
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947112


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

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Norwegian School of Sport Sciences
Oslo University Hospital
Investigators
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Principal Investigator: Tiina M Andersen, PhD Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway

Publications:
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03947112     History of Changes
Other Study ID Numbers: 2019/260
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
Physical activity level
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked