Physical Activity Level of Norwegian Boys With Duchenne Muscular Dystrophy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03947112|
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment|
|Duchenne Muscular Dystrophy||Behavioral: Physical activity registration|
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|
|Estimated Enrollment :||90 participants|
|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|
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.
- 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.
- 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
- 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.
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
|Contact: Stian Hammer, MScemail@example.com|
|Contact: Tiina M Andersen, PhD||+47 firstname.lastname@example.org|
|Haukeland University Hospital||Recruiting|
|Bergen, Hordaland, Norway, 5021|
|Principal Investigator:||Tiina M Andersen, PhD||Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway|