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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Duchenne Muscular Dystrophy
• Intervention / Treatment: 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)

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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Altındağ, Ankara, Turkey
      • Recruiting
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ambulatory children with Duchenne muscular dystrophy, between the ages of 8-14

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Duchenne Muscular Dystrophy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAQ-C	Physical activity level	10 to 15 minutes
MoCA	Cognitive function	10 to 15 minutes
Modified Mini Mental State Examination	Cognitive function	10 to 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PBS	Balance responses of participants	10 to 15 minutes
BMI	Body mass index to evaluate weight status of participants	1 minute

Collaborators and Investigators

• Sponsor: Muş Alparlan University
• Collaborators: Hacettepe University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2022
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (ACTUAL): December 8, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; cognitive function; muscular dystrophy
• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Dystrophies; Muscular Dystrophy, Duchenne
• Other Study ID Numbers: GO-22/1011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No