Regular Physical Exercise in Duchenne Muscular Dystrophy

NCT03963453 | Completed

• 1 other identifier: 2019/260 part II
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Muscular Dystrophy, Duchenne

Keywords

Physical Therapy Modalities; Exercise; Physical Activity; Exercise Program; Muscular Dystrophy, Duchenne

Outcome Measures

Primary Outcomes (1)

• Physical Activity Level

  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).

  Change from Baseline Physical Activity level at 12 months.

Secondary Outcomes (49)

• Physical Activity Questionnaire for children (PAQ-C)

  Change from Baseline PAQ-C score at 12 months

• Physical Activity Diary

  Day 1 (daily for seven days)

• Pediatric Quality of Life Inventory (PedsQL version 4). Child Report.

  Change from Baseline quality of life at 12 months

• North Star Ambulatory Assessment

  Change from Baseline functioning at 12 months

• "Egen Klassification 2- scale" (EK2 scale)

  Change from Baseline functioning at 12 months

Study Arms (2)

Interventional

Regular physical exercise group

Other: Physical Exercise

Control

Standards of care treatment

Interventions

Physical Exercise OTHER

Physical exercise are prescribed to be performed three times per week for a year

Interventional

Eligibility Criteria

• Age: 6 Years - 18 Years
• Gender Eligibility Details: DMD is a X-linked neuromuscular disease
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Patients with conclusive DMD diagnosis
• Written consent
• Able to perform physical exercise and answer questions

You may not qualify if:

• Lack of consent
• Cognitive disabled unable to answer questionnaire, understand instructions, and able to know what they participate in.
• Language difficulties

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Extrastiftelsen: collaborator

Study Sites (1)

Department of Physiotherapy. Haukeland University Hospital

Bergen, Norway, 5021, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Creatine Kinase (CK level)

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kjell Matre, PhD

  Orthopedic Clinik, Haukeland University Hospital, PB1400, 5021 Bergen/Norway

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 24, 2019
• Study Start: February 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: April 30, 2022
• Last Updated: March 5, 2025

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)