Duchenne Muscular DystrophyNCT03947112
Physical Activity Level of Norwegian Boys with Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Physical activity registration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- 20 Aug 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Lack of consent.
- Language difficulties
- Cognitive dysfunction or mental retardation leading to difficulties in answering the questionnaires adequately
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Physical activity registration
- Keywords
- Physical activity level
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity registrationBehavioural
Also called Self-report Questionnaire, Physical activity diary, UngKan-3 Questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| Norwegian population with Duchenne Muscular Dystrophy (DMD) | Boys with DMD. Receives: Behavioral: Physical activity registration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seven days
Secondary outcomes (2)
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.
Measured: Day 1
Self-Reported Questionnaire
Self-administrated questionnaire developed to describe participants function, on-going treatment, movement aid, types of physical activities
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start20 Aug 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Tiina M Andersen, PhD, Principal investigator, Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947112
- Sponsor's protocol ID
- 2019/260
- Status last verified
- Nov 2021
- First submitted
- 9 May 2019
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28112012Birnkrant 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.
PubMed 29395989
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Level of Norwegian Boys with Duchenne Muscular Dystrophy - a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03947112
- Acronym / sponsor ID
- 2019/260
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Physical activity level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Oslo University Hospital
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norwegian population with Duchenne Muscular Dystrophy (DMD) | – | Behavioral: Physical activity registrationBoys with DMD. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Lack of consent.
- Language difficulties
- Cognitive dysfunction or mental retardation leading to difficulties in answering the questionnaires adequately
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity registrationAlso: Self-report Questionnaire, Physical activity diary, UngKan-3 QuestionnaireAt 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. | Behavioural | Norwegian population with Duchenne Muscular Dystrophy (DMD) |
Primary outcome
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.
2 secondary outcomes
Leisure time physical activity
Time frame: Day 1
Self-Reported Questionnaire
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Background: PubMed 28112012Heutinck 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.
- Background: PubMed 29395989Birnkrant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiina M Andersen, PhD principal investigator
Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity registration (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03947112, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.