Muscular Dystrophy, DuchenneNCT05209087
Effects of Parental Influence on Physical Activity Level and Participation in Children With Duchenne Muscular Dystrophy
An observational study of Muscular Dystrophy, Duchenne, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years, men only
- Conditions the study is for
- Muscular Dystrophy, Duchenne
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Hacettepe University Faculty of Physical Therapy and Rehabilitation Pediatric Neuromuscular Diseases Unit
Who may be able to join
- 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
Who cannot join
- Have undergone any musculoskeletal surgery in the last 6 months that may affect gait
- Having compliance problems that cannot follow the physiotherapist's instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Parental Influence on Physical Activity Level And Participation in Children With Duchenne Muscular Dystrophy
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.
Read the detailed description
Duchenne Muscular Dystrophy (DMD) is the most common neuromuscular disease in childhood with an incidence of 1 per 3600-6000 live male births worldwide. It shows X-linked recessive inheritance. It is caused by a mutation in the gene encoding the dystrophin protein localized in Xp21.2. It is characterized by complete or partial deficiency of the cell membrane protein called dystrophin. Deficiency of dystrophin causes disruption of the structure of the muscle sarcolemma. Accordingly, the stress caused by repetitive contractions damages the sarcolemma. This deficiency leads to continuous degeneration of muscle fibers. As a result, it causes progressive loss in the strength of skeletal muscles, respiration and later cardiac muscles. As the disease progresses, due to muscle damage and weakness, the child's ability to perform daily tasks such as climbing stairs and walking short distances becomes impaired and functional skills decrease. Respiratory and cardiac muscle involvement is the most important cause of mortality in these patients before the age of 30.
Participation is a measurable outcome of health. This measure is defined as direct participation in life by the International Classification of Functioning, Disability and Health (ICF). Participation for children and youth includes activities such as personal care, mobility, social relations, education, play and leisure activities. Disabled children participate less in daily activities than healthy children.
Considering the progression of their diseases, the participation of children with DMD in physical activity decreases over time. Functional disorders in children with DMD affect their daily living activities, limiting their participation in similar activities with their peers. Research shows that children with DMD have lower levels of physical activity from a young age than their healthy peers. There are also studies in the literature showing that there is a decrease in the functional independence and quality of life of children with DMD as well as their families and caregivers.
Participation in regular physical activity in disabled children and youth contributes to physical, psychosocial and social development. Safe and effective physical activity can positively affect the nutritional status, mobility and social participation of patients with DMD throughout their lives. This indicates that we need to improve our understanding of the determinants and mechanisms underlying the thinking of children and adolescents with DMD regarding physical activity behaviors.
Parents play an important role in shaping their children's beliefs, attitudes, and behaviors across a wide range of developmental domains, including cognitive, social, and emotional domains. In addition to studies examining physical activity interventions for healthy children and youth, strong evidence has been shown that families can have a significant influence in increasing the physical activity of children and youth with disabilities. Parental behaviors that promote physical activity in children have two aspects: 1) role modeling, which includes efforts to be active alongside the parent's interest in physical activity, and 2) parental encouragement and involvement, providing access and opportunities for the child to be active (for example transport to sports complexes and parks). Studies examining the influence of parents on physical activity behaviors of children and adolescents shows that there is a positive relationship between parental behaviors and the activities in which children participate.
When the literature on individuals with DMD was examined, a limited number of studies were found that investigated both the physical activity level of the child with DMD and the effects of the parent on the activity level of the child with DMD. Therefore, the aims of our study are to determine the physical activity levels of school-age children with Duchenne Muscular Dystrophy who can walk and to investigate the effect of the family on the child's physical activity level and participation.
- Conditions
- Muscular Dystrophy, Duchenne
- Keywords
- duchenne muscular dystrophy, physical activity participation, parental influence, physical activity level
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Mar 2020
- Primary completion15 Jun 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular Dystrophy, DuchenneStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serenay Zorlu, Hacettepe University
- Investigators
- İpek Gürbüz, Assoc. Prof., Study chair, Hacettepe UniversitySerenay Zorlu, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209087
- Sponsor's protocol ID
- 16969557-451
- Status last verified
- Sep 2022
- First submitted
- 13 Jan 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parental Influence on Physical Activity Level And Participation in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05209087
- Acronym / sponsor ID
- 16969557-451
- Conditions
- Muscular Dystrophy, Duchenne
- Keywords
- duchenne muscular dystrophy, physical activity participation, parental influence, physical activity level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Duchenne Muscular Dystrophy (DMD) is the most common neuromuscular disease in childhood with an incidence of 1 per 3600-6000 live male births worldwide. It shows X-linked recessive inheritance. It is caused by a mutation in the gene encoding the dystrophin protein localized in Xp21.2. It is characterized by complete or partial deficiency of the cell membrane protein called dystrophin. Deficiency of dystrophin causes disruption of the structure of the muscle sarcolemma. Accordingly, the stress caused by repetitive contractions damages the sarcolemma. This deficiency leads to continuous degeneration of muscle fibers. As a result, it causes progressive loss in the strength of skeletal muscles, respiration and later cardiac muscles. As the disease progresses, due to muscle damage and weakness, the child's ability to perform daily tasks such as climbing stairs and walking short distances becomes impaired and functional skills decrease. Respiratory and cardiac muscle involvement is the most important cause of mortality in these patients before the age of 30.
Participation is a measurable outcome of health. This measure is defined as direct participation in life by the International Classification of Functioning, Disability and Health (ICF). Participation for children and youth includes activities such as personal care, mobility, social relations, education, play and leisure activities. Disabled children participate less in daily activities than healthy children.
Considering the progression of their diseases, the participation of children with DMD in physical activity decreases over time. Functional disorders in children with DMD affect their daily living activities, limiting their participation in similar activities with their peers. Research shows that children with DMD have lower levels of physical activity from a young age than their healthy peers. There are also studies in the literature showing that there is a decrease in the functional independence and quality of life of children with DMD as well as their families and caregivers.
Participation in regular physical activity in disabled children and youth contributes to physical, psychosocial and social development. Safe and effective physical activity can positively affect the nutritional status, mobility and social participation of patients with DMD throughout their lives. This indicates that we need to improve our understanding of the determinants and mechanisms underlying the thinking of children and adolescents with DMD regarding physical activity behaviors.
Parents play an important role in shaping their children's beliefs, attitudes, and behaviors across a wide range of developmental domains, including cognitive, social, and emotional domains. In addition to studies examining physical activity interventions for healthy children and youth, strong evidence has been shown that families can have a significant influence in increasing the physical activity of children and youth with disabilities. Parental behaviors that promote physical activity in children have two aspects: 1) role modeling, which includes efforts to be active alongside the parent's interest in physical activity, and 2) parental encouragement and involvement, providing access and opportunities for the child to be active (for example transport to sports complexes and parks). Studies examining the influence of parents on physical activity behaviors of children and adolescents shows that there is a positive relationship between parental behaviors and the activities in which children participate.
When the literature on individuals with DMD was examined, a limited number of studies were found that investigated both the physical activity level of the child with DMD and the effects of the parent on the activity level of the child with DMD. Therefore, the aims of our study are to determine the physical activity levels of school-age children with Duchenne Muscular Dystrophy who can walk and to investigate the effect of the family on the child's physical activity level and participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Hacettepe University Faculty of Physical Therapy and Rehabilitation Pediatric Neuromuscular Diseases Unit
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Have undergone any musculoskeletal surgery in the last 6 months that may affect gait
- Having compliance problems that cannot follow the physiotherapist's instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
International Physical Activity Questionnaire-Short Form-IPAQ-SF
Time frame: Baseline
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.
Physical Activity Questionnaire for Children-PAQ-C
Time frame: Baseline
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.
Physical Activity Questionnaire for Adolescents-PAQ-A
Time frame: Baseline
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.
Six Minute Walk Test-6MWT
Time frame: Baseline
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.
North Star Ambulatory Assessment-NSAD
Time frame: Baseline
North Star Ambulatory Assessment is a performance-based test developed to evaluate the ambulation level of children with DMD who can walk.
Children's Attraction to Physical Activity Scale-CAPA
Time frame: Baseline
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.
The Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: Baseline
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.
Pedometer
Time frame: 5 days
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.
Children's Physical Activity Correlates-CPAC
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İpek Gürbüz, Assoc. Prof. study chair
Hacettepe University
Serenay Zorlu principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscular Dystrophy, Duchenne, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire-Short Form-IPAQ-SF (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.