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

Duchenne Muscular Dystrophy Clinical Trial

Official title:

An Investigation of the Relationship Between Physical Activity Level and Cognitive Functions in Children With Duchenne Muscular Dystrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641805
• Other study ID #: GO-22/1011
• Status: Recruiting
• Start date: November 29, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: February 2023
• Source: Mus Alparlan University
• Contact: Bayram Sirri, PT, MSc,
• Phone: +905362410774
• Email: bayramsirri[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Altindag	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Mus Alparlan University	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAQ-C	Physical activity level	10 to 15 minutes
Primary	MoCA	Cognitive function	10 to 15 minutes
Primary	Modified Mini Mental State Examination	Cognitive function	10 to 15 minutes
Secondary	PBS	Balance responses of participants	10 to 15 minutes
Secondary	BMI	Body mass index to evaluate weight status of participants	1 minute