Physical Activity Level and Cognitive Functions in Children With Duchenne Muscular Dystrophy

NCT ID: NCT05641805

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2023-11-01

Brief Summary

Although there are studies showing that the effect on motor performance over time in children with DMD is associated with a decrease in the level of physical activity, no publication has been found that directly examines the relationship between cognitive functions and physical activity level. Therefore, the aim of our study is to investigate the relationship between physical activity level and cognitive functions in children with DMD.

Detailed Description

In DMD; as a result of mutations in the Xp21.2 region of the dystrophin gene, which encodes the dystrophin protein, which plays an important role in the normal contraction and relaxation of the muscle, progressive weakness starting from the proximal extremity muscles, chronic degeneration, replacement of the muscle with fat and connective tissue occurs due to the production of deficient or fully functional dystrophin. Although motor performance is one of the most prominent features in children with DMD, it has been reported that cognitive functions are also significantly affected in one third of children compared to their healthy peers. In addition, the physical activity levels of children with DMD show a significant decrease in physical activity levels after the age of 5, when motor problems are more pronounced than their healthy peers. Recently, interest in studies on physical activity level and cognitive skills in pediatric neuromuscular diseases such as DMD has increased, and studies have revealed the relationship between cognitive functions and motor performance. There are also studies showing that the effect on motor performance over time is associated with a decrease in physical activity level. However, there are no publications that directly examine the relationship between cognitive functions and physical activity level in children with DMD. Therefore, the primary aim of our study is; to investigate the relationship between physical activity level and cognitive functions in children with DMD. The secondary aims of our study are to reveal the relationship between balance and body mass index and physical activity level in children with DMD.

Conditions

Duchenne Muscular Dystrophy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Duchenne Muscular Dystrophy

PAQ-C (Physical activitiy questionare for children), MoCA (Montreal Cognitive Assessment), PBS (Pediatric Balance Scale), Modified Mini Mental State Examination, BMI (Body Mass Index)

Intervention Type: OTHER

PAQ-C will use to evaluate physical activity level of participants. MoCA and Modified Mini Mental State Examination will use to evaluate cognitive functions of participants.

PBS will use to evaluate participants' balance responses.

Interventions

PAQ-C (Physical activitiy questionare for children), MoCA (Montreal Cognitive Assessment), PBS (Pediatric Balance Scale), Modified Mini Mental State Examination, BMI (Body Mass Index)

PAQ-C will use to evaluate physical activity level of participants. MoCA and Modified Mini Mental State Examination will use to evaluate cognitive functions of participants.

PBS will use to evaluate participants' balance responses.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children who diagnosed with Duchenne Muscular Dystrophy (DMD), between the ages of 8-14, to have cognitive functions at a level to understand and apply test directives, Level 1-5 according to Brooke lower extremity functional classification will be included.

Exclusion Criteria

• Children who have any chronic or systemic disease in addition to DMD, being above level 5 according to the Brooke lower extremity functional classification, have a cooperation problem, have had any lower/upper extremity injury and/or surgery in the last 6 months and children who did not give consent will be excluded.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Muş Alparslan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayram Sırrı, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Altındağ, Ankara, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Bayram Sırrı, PT, MSc,

Role: CONTACT

bayramsirri@gmail.com

+905362410774

Facility Contacts

Bayram Sırrı, MSc

Role: primary

bayramsirri@gmail.com

05362410774

Other Identifiers

GO-22/1011

Identifier Type: -

Identifier Source: org_study_id