Clinical trial NCT05641805: Physical Activity Level and Cognitive Functions in Children With Duchenne Muscular Dystrophy
Official title: An Investigation of the Relationship Between Physical Activity Level and Cognitive Functions in Children With Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Duchenne Muscular Dystrophy
Keywords: muscular dystrophy
physical activity
cognitive function
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2022-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory children with Duchenne muscular dystrophy, between the ages of 8-14

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.

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.

Primary outcomes:
measure: PAQ-C
timeFrame: 10 to 15 minutes
measure: MoCA
timeFrame: 10 to 15 minutes
measure: Modified Mini Mental State Examination
timeFrame: 10 to 15 minutes
Secondary outcomes:
measure: PBS
timeFrame: 10 to 15 minutes
measure: BMI
timeFrame: 1 minute
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Hacettepe University
state: Ankara
Study officials:
affiliation: Hacettepe University
name: Bayram Sırrı, MSc
role: PRINCIPAL_INVESTIGATOR
References: