Condition or disease | Intervention/treatment |
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Muscular Dystrophy, Duchenne | Other: Physical Exercise |
Regular physical activity is recommended in DMD. However, due to progression of muscle weakness and loss of function, a sedentary lifestyle is normal, and disuse of still functioning muscles leads to a secondary deterioration. Use of steroids have proven to decrease the rate of progression, and also leads to adverse advents like obesity and osteoporosis.
Use of muscle strength training and aerobe exercise in DMD, may optimize muscle function, cardio-respiratory fitness and overall physical activity level, in addition to decrease possible adverse advents.
In this study, children with DMD attending Haukeland University Hospital will be invited to participate (N≈14). The participant's physical activity level is registered during a four week baseline period and follow up. At start, 6 months and 12 months, a five day hospital stay will be conducted, both for testing and to prescribe an individual user preferred physical exercise program. The exercise program will be performed at home between the hospital visits. Benefits, safety and feasibility of regular physical exercise will be examined during follow-up and end of study. For comparison of the physical activity level and motor function, DMD children attending standards of care follow-up at others Norwegian regional pediatric rehabilitation clinics will be invited to participate in a control group.
Study Type : | Observational |
Estimated Enrollment : | 14 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | To Train -or Not to Train? The Role of Physical Exercise as Part of Management in Duchenne Muscular Dystrophy |
Actual Study Start Date : | February 1, 2021 |
Estimated Primary Completion Date : | March 30, 2022 |
Estimated Study Completion Date : | May 30, 2023 |
Group/Cohort | Intervention/treatment |
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Interventional
Regular physical exercise group
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Other: Physical Exercise
Physical exercise are prescribed to be performed three times per week for a year
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Control
Standards of care treatment
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The PAQ-C is a self-administrated, 7 day recall instrument, developed to assess general levels of physical activity throughout the elementary school year. The PAQ-C provides a summary physical activity score derived from nine items, each scored on a 5-point scale. The nine items and scores are:
9. How often did you do physical activities for each weekday? None=score 1 Little bit = score 2, Medium = score 3, Often = score 4, Very often = Score 5. Item 9 mean score is reported. Total score 45 represents the participant's general level of physical activity. The participants perform the PAQ-C at baseline and at every hospital visit (start, 6 and 12 months).
Venous blood samples, as biomarker for muscle inflammation or tissue damage, measured by U/L.
Assessment of CK will be performed for safety reasons due to intervention. Blood samples will be performed three mornings during the hospital visits.
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 a X-linked neuromuscular disease |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Boys with DMD from Hordaland county, attending the pediatric rehabilitation centre at Haukeland university hospital, will be recruited for intervention.
For comparison, boys with DMD, attending other Norwegian pediatric rehabilitation centres will be invited as control group. Assessment of their physical activity level and self-reported physical activity level will be examined at start and after 12 months. In addition, functional abilities by use of North Star ambulatory assessment or EK2 scale will be assessed.
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Department of Physiotherapy. Haukeland University Hospital | |
Bergen, Norway, 5021 |
Study Chair: | Kjell Matre, PhD | Orthopedic Clinik, Haukeland University Hospital, PB1400, 5021 Bergen/Norway |
Tracking Information | |||||||
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First Submitted Date | May 9, 2019 | ||||||
First Posted Date | May 24, 2019 | ||||||
Last Update Posted Date | February 23, 2021 | ||||||
Actual Study Start Date | February 1, 2021 | ||||||
Estimated Primary Completion Date | March 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Physical Activity Level [ Time Frame: Change from Baseline Physical Activity level at 12 months. ] The participants physical activity level will be monitored by use of an ActiGraph for seven days including a weekend. Two registrations will take place during a four week baseline period, followed by additional registrations at 3, 6, 9 and 12 months (intervention period).
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Regular Physical Exercise in Duchenne Muscular Dystrophy | ||||||
Official Title | To Train -or Not to Train? The Role of Physical Exercise as Part of Management in Duchenne Muscular Dystrophy | ||||||
Brief Summary | This study examine whether an evidence-based individual user-preferred exercise program will increase the physical activity level in boys with Duchenne muscular Dystrophy (DMD). | ||||||
Detailed Description |
Regular physical activity is recommended in DMD. However, due to progression of muscle weakness and loss of function, a sedentary lifestyle is normal, and disuse of still functioning muscles leads to a secondary deterioration. Use of steroids have proven to decrease the rate of progression, and also leads to adverse advents like obesity and osteoporosis. Use of muscle strength training and aerobe exercise in DMD, may optimize muscle function, cardio-respiratory fitness and overall physical activity level, in addition to decrease possible adverse advents. In this study, children with DMD attending Haukeland University Hospital will be invited to participate (N≈14). The participant's physical activity level is registered during a four week baseline period and follow up. At start, 6 months and 12 months, a five day hospital stay will be conducted, both for testing and to prescribe an individual user preferred physical exercise program. The exercise program will be performed at home between the hospital visits. Benefits, safety and feasibility of regular physical exercise will be examined during follow-up and end of study. For comparison of the physical activity level and motor function, DMD children attending standards of care follow-up at others Norwegian regional pediatric rehabilitation clinics will be invited to participate in a control group. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Retention: Samples Without DNA Description:
Creatine Kinase (CK level)
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Sampling Method | Non-Probability Sample | ||||||
Study Population |
Boys with DMD from Hordaland county, attending the pediatric rehabilitation centre at Haukeland university hospital, will be recruited for intervention. For comparison, boys with DMD, attending other Norwegian pediatric rehabilitation centres will be invited as control group. Assessment of their physical activity level and self-reported physical activity level will be examined at start and after 12 months. In addition, functional abilities by use of North Star ambulatory assessment or EK2 scale will be assessed. |
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Condition | Muscular Dystrophy, Duchenne | ||||||
Intervention | Other: Physical Exercise
Physical exercise are prescribed to be performed three times per week for a year
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Enrolling by invitation | ||||||
Estimated Enrollment |
14 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | May 30, 2023 | ||||||
Estimated Primary Completion Date | March 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 | NCT03963453 | ||||||
Other Study ID Numbers | 2019/260 part II | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Haukeland University Hospital | ||||||
Study Sponsor | Haukeland University Hospital | ||||||
Collaborators | Extrastiftelsen | ||||||
Investigators |
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PRS Account | Haukeland University Hospital | ||||||
Verification Date | August 2020 |