NCT05209087

Brief Summary

This study was planned to investigate the parental influence on physical activity (PA) level and participation in ambulatory children with Duchenne muscular dystrophy (DMD). For this purpose, 30 children with DMD between the ages of 8-18, who were between Levels 1-4 according to the Brooke Lower Extremity Functional Classification (BLEFC), were included in the study. The demographic information of the participants and their detailed information about the disease were recorded. Parents' PA level was assessed via International Physical Activity Questionnaire-Short Form (IPAQ-SF); Children's PA level was assessed via Physical Activity Questionnaire for Children (PAQ-C) and pedometer, participation was assessed via Pediatric Outcomes Data Collection Instrument (PODCI), and parental influence was assessed via Children's Physical Activity Correlates (CPAC). Additionally, children's PA interest was assessed via Children's Attraction to Physical Activity (CAPA). SPSS 25 program was used in the statistical analysis of the evaluation results. The mean age of the individuals included in the study was found to be 8,70±0,84. Parental influence evaluations, positive and weak-moderate correlations were determined between CPAC Questionnaire "Parental Influence" sub-dimension with PAQ-C (r=0,582), CAPA (0,432) and PODCI (r=0,372) (p\<0,05). A positive, moderate correlation was found between the PA levels of mothers obtained from IPAQ-SF and PAQ-C (p\<0,01). The results of the study show that the parents, especially the mother who is the primary caregiver, can be an important factor to improve the PA levels, increase their attraction to PA and participation in children with DMD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

2.3 years

First QC Date

January 13, 2022

Last Update Submit

September 6, 2022

Conditions

Keywords

duchenne muscular dystrophyphysical activity participationparental influencephysical activity level

Outcome Measures

Primary Outcomes (9)

  • International Physical Activity Questionnaire-Short Form-IPAQ-SF

    The International Physical Activity Questionnaire-Short Form is used to determine the physical activity level of parents between the ages of 18-65. It contains 7 questions about the activities done in the last 7 days.

    Baseline

  • Physical Activity Questionnaire for Children-PAQ-C

    The Physical Activity Questionnaire for Children is used to determine the physical activity level of children between the ages of 8-14. It contains 7 questions about the activities done in the last 7 days.

    Baseline

  • Physical Activity Questionnaire for Adolescents-PAQ-A

    The Physical Activity Questionnaire for Adolescents is used to determine the physical activity level of children between the ages of 14-18. It contains 7 questions about the activities done in the last 7 days.

    Baseline

  • Six Minute Walk Test-6MWT

    Six Minute Walk Test is used to measure walking function and physical capacity at the submaximal level in children with DMD. 6MWT is used as the gold standard in evaluating the functional capacity of patient with Duchenne Muscular Dystrophy.

    Baseline

  • North Star Ambulatory Assessment-NSAD

    North Star Ambulatory Assessment is a performance-based test developed to evaluate the ambulation level of children with DMD who can walk.

    Baseline

  • Children's Attraction to Physical Activity Scale-CAPA

    Children's Attraction to Physical Activity Scale is a questionnaire that used to assess children's interest in physical activity. It consists of 15 questions. The questionnaire is filled by the researcher reading the questions aloud and the child responding.

    Baseline

  • The Pediatric Outcomes Data Collection Instrument (PODCI)

    The Pediatric Outcomes Data Collection Instrument is a questionnaire used to measure functional outcomes. Functional dimensions assessed include upper extremity functioning, transfers and basic mobility, sports and physical function, comfort/pain, global function and happiness with physical condition. This study uses PODCI to quantify the physical activity participation of a group of DMD patients.

    Baseline

  • Pedometer

    Pedometers are measurement tools developed for counting steps that can measure and record vertical movements. This study used pedometer to determine the physical activity level of children.

    5 days

  • Children's Physical Activity Correlates-CPAC

    Children's Physical Activity Correlates used to evaluate the factors affecting physical activity in children. It consists of 44 questions. The questionnaire is filled by the researcher reading the questions aloud and the child responding.

    Baseline

Study Arms (1)

Children with Duchenne Muscular Dystrophy

Children with Duchenne Muscular Dystrophy who are between Levels 1-4 (continuing ambulation) according to Brooke Lower Extremity Functional Classification will be included in the study. This classification method was designed on the basis of the classification method to determine the functional status of the lower and upper extremities in the clinical evaluation of Duchenne Muscular Dystrophy.

Eligibility Criteria

Age8 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Hacettepe University Faculty of Physical Therapy and Rehabilitation Pediatric Neuromuscular Diseases Unit

You may qualify if:

  • Participating in the study on a voluntary basis
  • The ages of 8 and 18 who have been diagnosed with Duchenne Muscular Dystrophy
  • Being in the first four levels according to the Brooke Lower Extremity Functional -Classification (BAEFS) (ambulatory children)
  • Not having difficulties in cooperation

You may not qualify if:

  • Have undergone any musculoskeletal surgery in the last 6 months that may affect gait
  • Having compliance problems that cannot follow the physiotherapist's instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • İpek Gürbüz, Assoc. Prof.

    Hacettepe University

    STUDY CHAIR
  • Serenay Zorlu

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 26, 2022

Study Start

March 1, 2020

Primary Completion

June 15, 2022

Study Completion

August 15, 2022

Last Updated

September 9, 2022

Record last verified: 2022-09

Locations