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出境医 / 临床实验 / Physical Activity Level of Norwegian Boys With Duchenne Muscular Dystrophy

Physical Activity Level of Norwegian Boys With Duchenne Muscular Dystrophy

Study Description
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.

Study Design
Layout table for study information
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
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021
Arms 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
Outcome Measures
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. Leisure time physical activity [ Time Frame: Day 1 ]
    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.

  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.


Eligibility Criteria
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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
Contacts and Locations

Locations
Layout table for location information
Norway
Haukeland University Hospital
Bergen, Hordaland, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Norwegian School of Sport Sciences
Oslo University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Tiina M Andersen, PhD Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway
Tracking Information
First Submitted Date May 9, 2019
First Posted Date May 13, 2019
Last Update Posted Date February 23, 2021
Actual Study Start Date August 20, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 16, 2020)
  • Leisure time physical activity [ Time Frame: Day 1 ]
    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.
  • Self-Reported Questionnaire [ Time Frame: Day 1 ]
    Self-administrated questionnaire developed to describe participants function, on-going treatment, movement aid, types of physical activities
Original Secondary Outcome Measures
 (submitted: May 9, 2019)
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2019) 		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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Duchenne Muscular Dystrophy
Intervention 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
Study Groups/Cohorts Norwegian population with Duchenne Muscular Dystrophy (DMD)
Boys with DMD.
Intervention: Behavioral: Physical activity registration
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. Review. Erratum in: Lancet Neurol. 2018 Apr 4;:.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 9, 2019) 		90
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: DMD is X-linked disease
Ages 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03947112
Other Study ID Numbers 2019/260
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Haukeland University Hospital
Study Sponsor Haukeland University Hospital
Collaborators
  • Norwegian School of Sport Sciences
  • Oslo University Hospital
Investigators
Principal Investigator: Tiina M Andersen, PhD Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway
PRS Account Haukeland University Hospital
Verification Date February 2020

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