Regular Physical Exercise in Duchenne Muscular Dystrophy

NCT ID: NCT03963453

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-04-30

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.

Conditions

Muscular Dystrophy, Duchenne

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Interventional

Regular physical exercise group

Physical Exercise

Intervention Type: OTHER

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

Control

Standards of care treatment

No interventions assigned to this group

Interventions

Physical Exercise

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Extrastiftelsen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kjell Matre, PhD

Role: STUDY_CHAIR

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

Locations

Department of Physiotherapy. Haukeland University Hospital

Bergen, Norway, Norway

Countries

Norway

Other Identifiers

2019/260 part II

Identifier Type: -

Identifier Source: org_study_id