Duchenne Muscular Dystrophy (DMD)NCT07369609
Factors Influencing Physical Activity Levels in Children With Duchenne Muscular Dystrophy: An ICF-CY-Based Study
An observational study of Duchenne Muscular Dystrophy (DMD), run by Hacettepe University.
Trial summary
Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized not only by progressive muscle weakness but also by cognitive, behavioral, and psychosocial impairments. Read more about this study
- Who is it for?
- Ages 6 to 14 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2026to 2 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 14 years
- Men only
- No healthy volunteers
- Child
Study population: The study population will consist of children diagnosed with Duchenne Muscular Dystrophy (DMD) and their parents or primary caregivers. Eligible children will be males aged 6 to 14 years with a confirmed diagnosis of DMD who are ambulatory, classified within the first four levels of the Brooke Lower Extremity Functional Classification, and able to follow assessment instructions. Parents or primary caregivers of these children who voluntarily agree to participate will also be included. Participants will be recruited from pediatric neuromuscular rehabilitation and physiotherapy settings.
Who may be able to join
- Being a parent or primary caregiver of a child diagnosed with Duchenne Muscular Dystrophy (DMD),
- Volunteering to participate in the study.
- Having a confirmed diagnosis of Duchenne Muscular Dystrophy (DMD),
- Being between 6 and 14 years of age,
- Being classified within the first four levels of the Brooke Lower Extremity Functional Classification (ambulatory children),
- Scoring >24 on the Modified Mini-Mental State Examination,
- Volunteering to participate in the study.
Who cannot join
- Having caregiving responsibilities for another child or adult with a disability, other than the child with DMD,
- Experiencing difficulties in understanding or responding to the questionnaires administered by the physiotherapist.
- Having undergone any musculoskeletal surgery or sustained an injury that could affect physical activity within the past 6 months,
- Experiencing difficulty in understanding the test instructions administered by the physiotherapist and therefore being unable to appropriately perform the tests (performance-based assessments),
- Experiencing difficulties in understanding or responding to the questionnaires administered by the physiotherapist.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
İpek Gürbüz, Professor contact
About this study
Official title: Investigation of Factors Affecting Physical Activity Level in Children With Duchenne Muscular Dystrophy Based on the International Classification of Functioning, Disability and Health - Child and Youth Version
Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized not only by progressive muscle weakness but also by cognitive, behavioral, and psychosocial impairments. Motor losses that occur during disease progression reduce physical activity levels in children and increase the risk of developing a sedentary lifestyle. Interventions aimed at maintaining or promoting physical activity in children with DMD are important for preventing secondary complications associated with disuse and physical inactivity. To develop effective interventions, there is a need for comprehensive knowledge regarding the factors that influence physical activity levels.
Current literature indicates that, in typically developing children, physical activity levels are influenced not only by motor factors but also by cognitive status, sleep, behavioral characteristics, and family-related environmental and psychosocial factors. However, information regarding these multidimensional factors affecting physical activity levels in children with DMD remains limited.
This study aims to identify the body functions, activity, participation, environmental, and personal factors affecting physical activity levels in children with DMD based on the framework of the International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY). Accordingly, the effects of posture, functional capacity, ambulatory status, balance, other musculoskeletal parameters, cognitive status, sleep habits and sleep quality, fear of falling, and behavioral characteristics, as well as family-related factors including parenting style, perceptions of physical activity, stress level, attitudes and perceptions toward daily life events, and disease impact, will be evaluated. The impact of these variables on physical activity levels and the magnitude of this effect will be examined within the ICF-CY framework.
Read the detailed description
Duchenne Muscular Dystrophy (DMD) is the most common inherited neuromuscular disorder, affecting approximately one in 3,500-5,000 live male births worldwide. It is caused by various mutations in the dystrophin gene located on Xp21.2, most commonly deletions and duplications, leading to the absence of dystrophin protein in skeletal muscle, cardiac muscle, and the central nervous system. The lack of dystrophin results in progressive muscle weakness beginning in early childhood, typically between 18 months and 3 years of age, followed by gradual loss of ambulation, increasing dependence in daily activities, and the development of serious cardiac, respiratory, and orthopedic complications later in life.
In addition to motor impairments, dystrophin deficiency in the brain has been associated with cognitive, behavioral, and psychosocial difficulties. DMD-related mutations affect multiple dystrophin isoforms that are expressed in key brain regions involved in attention, memory, executive functions, and emotional regulation. As a result, children with DMD frequently present with impairments in attention, executive functioning, learning, behavior, and emotional regulation. These non-motor manifestations further complicate disease management and have a substantial impact on participation in daily life and overall quality of life for both children and their families.
During disease progression, increasing motor limitations significantly restrict children's engagement in physical activity and increase the likelihood of adopting a sedentary lifestyle. Reduced physical activity contributes to secondary complications related to disuse, such as decreased cardiorespiratory fitness, reduced bone mineral density, increased fatigue, and further functional decline. Therefore, maintaining and supporting physical activity is considered a critical component of comprehensive care in children with DMD. However, the development of effective and sustainable physical activity-related interventions requires a thorough understanding of the factors influencing physical activity behavior in this population.
In typically developing children, physical activity levels are known to be influenced by a wide range of motor and non-motor factors, including physical function, cognitive status, sleep habits, behavioral characteristics, and family-related environmental and psychosocial factors. Although similar interactions are likely to exist in children with DMD, current evidence regarding the multidimensional determinants of physical activity in this population remains limited. In particular, the combined influence of body functions, activity limitations, participation restrictions, and family-related factors has not been sufficiently investigated within a comprehensive conceptual framework.
The International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY), developed by the World Health Organization, provides a biopsychosocial model that enables a holistic evaluation of health by considering body functions and structures, activity, participation, and contextual factors. Using the ICF-CY framework allows for the systematic examination of the dynamic interactions between individual and environmental factors that shape physical activity behavior in children with chronic health conditions.
Therefore, the primary aim of this study is to identify the factors affecting physical activity levels in children with Duchenne Muscular Dystrophy within the ICF-CY framework. Specifically, the study will evaluate the influence of posture, functional capacity, ambulatory status, balance, fatigue, gait, and other musculoskeletal parameters, as well as cognitive status, sleep habits and sleep quality, fear of falling, behavioral characteristics, and motivation on children's physical activity levels. In addition, family-related factors-including caregiver sleep quality, parenting style, perceptions of physical activity, stress level, attitudes and perceptions toward daily life events, and perceived disease impact-will be examined to determine their contribution to physical activity behavior.
By adopting a comprehensive ICF-CY-based approach, this study aims to clarify the relative contribution and magnitude of individual, environmental, and psychosocial factors influencing physical activity levels in children with DMD. The findings are expected to provide clinically relevant insights that may guide the development of targeted, family-centered, and multidimensional interventions aimed at maintaining or enhancing physical activity and improving long-term health outcomes and quality of life in children with Duchenne Muscular Dystrophy.
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- duchenne muscular dystrophy, physical activity, ICF-CY
- Medical subject headings
- Muscular Dystrophy, Duchenne, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Questionnaire for Children-PAQ-C
The physical activity level of children with DMD will be assessed using the Physical Activity Questionnaire for Children (PAQ-C).
Measured: At baseline (single assessment at enrollment)
The New York Posture Rating Chart
The New York Posture Rating Chart will be used to assess posture in children with DMD.
Measured: At baseline (single assessment at enrollment)
Six Minute Walk Test (6MWT)
The 6MWT will be used to evaluate functional capacity in children with DMD.
Measured: At baseline (single assessment at enrollment)
Pediatric Quality of Life Inventory - Multidimensional Fatigue Scale (PedsQL-MFS)
Fatigue in children with DMD will be assessed using the PedsQL-MFS.
Measured: At baseline (single assessment at enrollment)
Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)
Gait characteristics of children with DMD will be evaluated using the DMD-GAS.
Measured: At baseline (single assessment at enrollment)
North Star Ambulatory Assessment (NSAA)
Ambulatory status of children with DMD will be assessed using the NSAA.
Measured: At baseline (single assessment at enrollment)
Four Square Step Test (FSST)
Balance in children with DMD will be evaluated using the FSST.
Measured: At baseline (single assessment at enrollment)
Lower Extremity Muscle Strength Assessment
Myometric measurements will be performed to assess lower extremity muscle strength in children with DMD.
Measured: At baseline (single assessment at enrollment)
Assessment of Lower Extremity Joint Range of Motion
Active and passive range of motion of the lower extremity joints will be assessed using goniometric measurements.
Measured: At baseline (single assessment at enrollment)
Muscle Shortness Assessment
Muscle length tests will be applied to determine muscle shortness in children with DMD.
Measured: At baseline (single assessment at enrollment)
Modified Mini-Mental State Examination (MMSE)
The Modified MMSE will be used to determine the cognitive level of children with DMD.
Measured: At baseline (single assessment at enrollment)
Trail Making Test
The Trail Making Test will be used to assess cognitive functions such as attention, planning, and executive functions in children with DMD.
Measured: At baseline (single assessment at enrollment)
Children's Sleep Habits Questionnaire (CSHQ) - Short Form
The CSHQ will be used to assess sleep problems in children with DMD.
Measured: At baseline (single assessment at enrollment)
Pediatric Sleep Questionnaire - Sleep-Related Breathing Disorder Subscale (PSQ-SRBD)
The PSQ-SRBD subscale will be used to evaluate sleep-related breathing disorders in children with DMD.
Measured: At baseline (single assessment at enrollment)
ICF-Based Fear of Falling Form for Pediatric Neuromuscular Diseases (Ped-FOF)
The Ped-FOF will be used to assess fear of falling in children with DMD.
Measured: At baseline (single assessment at enrollment)
Strengths and Difficulties Questionnaire (SDQ)
Behavioral problems in children with DMD will be assessed using the SDQ.
Measured: At baseline (single assessment at enrollment)
Pediatric Motivation Scale (PMS)
Motivation levels of children with DMD will be assessed using the PMS.
Measured: At baseline (single assessment at enrollment)
Pittsburgh Sleep Quality Index (PSQI)
Parental sleep quality will be evaluated using the PSQI.
Measured: At baseline (single assessment at enrollment)
Parenting Scale
The Parenting Scale will be used to assess parents' disciplinary practices.
Measured: At baseline (single assessment at enrollment)
Perceived Barriers to Physical Activity Scale
Parents' perceived barriers to participation in physical activity will be assessed using the Perceived Barriers to Physical Activity Scale.
Measured: At baseline (single assessment at enrollment)
Perceived Stress Scale (PSS)
Parental stress levels will be assessed using the PSS.
Measured: At baseline (single assessment at enrollment)
Cognitive Control and Flexibility Scale (CCFS)
The CCFS will be used to assess parents' cognitive flexibility in stressful situations.
Measured: At baseline (single assessment at enrollment)
Impact on Family Scale (IPFAM)
The level of disease-related impact on parents will be assessed using the IPFAM.
Measured: At baseline (single assessment at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serenay Zorlu, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369609
- Sponsor's protocol ID
- FTREK25/64
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Affecting Physical Activity Level in Children With Duchenne Muscular Dystrophy Based on the International Classification of Functioning, Disability and Health - Child and Youth Version
- ClinicalTrials.gov ID
- NCT07369609
- Acronym / sponsor ID
- FTREK25/64
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- duchenne muscular dystrophy, physical activity, ICF-CY
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 27 Jan 2026 (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.
Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized not only by progressive muscle weakness but also by cognitive, behavioral, and psychosocial impairments. Motor losses that occur during disease progression reduce physical activity levels in children and increase the risk of developing a sedentary lifestyle. Interventions aimed at maintaining or promoting physical activity in children with DMD are important for preventing secondary complications associated with disuse and physical inactivity. To develop effective interventions, there is a need for comprehensive knowledge regarding the factors that influence physical activity levels.
Current literature indicates that, in typically developing children, physical activity levels are influenced not only by motor factors but also by cognitive status, sleep, behavioral characteristics, and family-related environmental and psychosocial factors. However, information regarding these multidimensional factors affecting physical activity levels in children with DMD remains limited.
This study aims to identify the body functions, activity, participation, environmental, and personal factors affecting physical activity levels in children with DMD based on the framework of the International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY). Accordingly, the effects of posture, functional capacity, ambulatory status, balance, other musculoskeletal parameters, cognitive status, sleep habits and sleep quality, fear of falling, and behavioral characteristics, as well as family-related factors including parenting style, perceptions of physical activity, stress level, attitudes and perceptions toward daily life events, and disease impact, will be evaluated. The impact of these variables on physical activity levels and the magnitude of this effect will be examined within the ICF-CY framework.
Detailed description
Duchenne Muscular Dystrophy (DMD) is the most common inherited neuromuscular disorder, affecting approximately one in 3,500-5,000 live male births worldwide. It is caused by various mutations in the dystrophin gene located on Xp21.2, most commonly deletions and duplications, leading to the absence of dystrophin protein in skeletal muscle, cardiac muscle, and the central nervous system. The lack of dystrophin results in progressive muscle weakness beginning in early childhood, typically between 18 months and 3 years of age, followed by gradual loss of ambulation, increasing dependence in daily activities, and the development of serious cardiac, respiratory, and orthopedic complications later in life.
In addition to motor impairments, dystrophin deficiency in the brain has been associated with cognitive, behavioral, and psychosocial difficulties. DMD-related mutations affect multiple dystrophin isoforms that are expressed in key brain regions involved in attention, memory, executive functions, and emotional regulation. As a result, children with DMD frequently present with impairments in attention, executive functioning, learning, behavior, and emotional regulation. These non-motor manifestations further complicate disease management and have a substantial impact on participation in daily life and overall quality of life for both children and their families.
During disease progression, increasing motor limitations significantly restrict children's engagement in physical activity and increase the likelihood of adopting a sedentary lifestyle. Reduced physical activity contributes to secondary complications related to disuse, such as decreased cardiorespiratory fitness, reduced bone mineral density, increased fatigue, and further functional decline. Therefore, maintaining and supporting physical activity is considered a critical component of comprehensive care in children with DMD. However, the development of effective and sustainable physical activity-related interventions requires a thorough understanding of the factors influencing physical activity behavior in this population.
In typically developing children, physical activity levels are known to be influenced by a wide range of motor and non-motor factors, including physical function, cognitive status, sleep habits, behavioral characteristics, and family-related environmental and psychosocial factors. Although similar interactions are likely to exist in children with DMD, current evidence regarding the multidimensional determinants of physical activity in this population remains limited. In particular, the combined influence of body functions, activity limitations, participation restrictions, and family-related factors has not been sufficiently investigated within a comprehensive conceptual framework.
The International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY), developed by the World Health Organization, provides a biopsychosocial model that enables a holistic evaluation of health by considering body functions and structures, activity, participation, and contextual factors. Using the ICF-CY framework allows for the systematic examination of the dynamic interactions between individual and environmental factors that shape physical activity behavior in children with chronic health conditions.
Therefore, the primary aim of this study is to identify the factors affecting physical activity levels in children with Duchenne Muscular Dystrophy within the ICF-CY framework. Specifically, the study will evaluate the influence of posture, functional capacity, ambulatory status, balance, fatigue, gait, and other musculoskeletal parameters, as well as cognitive status, sleep habits and sleep quality, fear of falling, behavioral characteristics, and motivation on children's physical activity levels. In addition, family-related factors-including caregiver sleep quality, parenting style, perceptions of physical activity, stress level, attitudes and perceptions toward daily life events, and perceived disease impact-will be examined to determine their contribution to physical activity behavior.
By adopting a comprehensive ICF-CY-based approach, this study aims to clarify the relative contribution and magnitude of individual, environmental, and psychosocial factors influencing physical activity levels in children with DMD. The findings are expected to provide clinically relevant insights that may guide the development of targeted, family-centered, and multidimensional interventions aimed at maintaining or enhancing physical activity and improving long-term health outcomes and quality of life in children with Duchenne Muscular Dystrophy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will consist of children diagnosed with Duchenne Muscular Dystrophy (DMD) and their parents or primary caregivers. Eligible children will be males aged 6 to 14 years with a confirmed diagnosis of DMD who are ambulatory, classified within the first four levels of the Brooke Lower Extremity Functional Classification, and able to follow assessment instructions. Parents or primary caregivers of these children who voluntarily agree to participate will also be included. Participants will be recruited from pediatric neuromuscular rehabilitation and physiotherapy settings.
Key inclusion criteria (7 listed)
Key exclusion criteria (5 listed)
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
Physical Activity Questionnaire for Children-PAQ-C
Time frame: At baseline (single assessment at enrollment)
The physical activity level of children with DMD will be assessed using the Physical Activity Questionnaire for Children (PAQ-C).
The New York Posture Rating Chart
Time frame: At baseline (single assessment at enrollment)
The New York Posture Rating Chart will be used to assess posture in children with DMD.
Six Minute Walk Test (6MWT)
Time frame: At baseline (single assessment at enrollment)
The 6MWT will be used to evaluate functional capacity in children with DMD.
Pediatric Quality of Life Inventory - Multidimensional Fatigue Scale (PedsQL-MFS)
Time frame: At baseline (single assessment at enrollment)
Fatigue in children with DMD will be assessed using the PedsQL-MFS.
Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)
Time frame: At baseline (single assessment at enrollment)
Gait characteristics of children with DMD will be evaluated using the DMD-GAS.
North Star Ambulatory Assessment (NSAA)
Time frame: At baseline (single assessment at enrollment)
Ambulatory status of children with DMD will be assessed using the NSAA.
Four Square Step Test (FSST)
Time frame: At baseline (single assessment at enrollment)
Balance in children with DMD will be evaluated using the FSST.
Lower Extremity Muscle Strength Assessment
Time frame: At baseline (single assessment at enrollment)
Myometric measurements will be performed to assess lower extremity muscle strength in children with DMD.
Assessment of Lower Extremity Joint Range of Motion
Time frame: At baseline (single assessment at enrollment)
Active and passive range of motion of the lower extremity joints will be assessed using goniometric measurements.
Muscle Shortness Assessment
Time frame: At baseline (single assessment at enrollment)
Muscle length tests will be applied to determine muscle shortness in children with DMD.
Modified Mini-Mental State Examination (MMSE)
Time frame: At baseline (single assessment at enrollment)
The Modified MMSE will be used to determine the cognitive level of children with DMD.
Trail Making Test
Time frame: At baseline (single assessment at enrollment)
The Trail Making Test will be used to assess cognitive functions such as attention, planning, and executive functions in children with DMD.
Children's Sleep Habits Questionnaire (CSHQ) - Short Form
Time frame: At baseline (single assessment at enrollment)
The CSHQ will be used to assess sleep problems in children with DMD.
Pediatric Sleep Questionnaire - Sleep-Related Breathing Disorder Subscale (PSQ-SRBD)
Time frame: At baseline (single assessment at enrollment)
The PSQ-SRBD subscale will be used to evaluate sleep-related breathing disorders in children with DMD.
ICF-Based Fear of Falling Form for Pediatric Neuromuscular Diseases (Ped-FOF)
Time frame: At baseline (single assessment at enrollment)
The Ped-FOF will be used to assess fear of falling in children with DMD.
Strengths and Difficulties Questionnaire (SDQ)
Time frame: At baseline (single assessment at enrollment)
Behavioral problems in children with DMD will be assessed using the SDQ.
Pediatric Motivation Scale (PMS)
Time frame: At baseline (single assessment at enrollment)
Motivation levels of children with DMD will be assessed using the PMS.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At baseline (single assessment at enrollment)
Parental sleep quality will be evaluated using the PSQI.
Parenting Scale
Time frame: At baseline (single assessment at enrollment)
The Parenting Scale will be used to assess parents' disciplinary practices.
Perceived Barriers to Physical Activity Scale
Time frame: At baseline (single assessment at enrollment)
Parents' perceived barriers to participation in physical activity will be assessed using the Perceived Barriers to Physical Activity Scale.
Perceived Stress Scale (PSS)
Time frame: At baseline (single assessment at enrollment)
Parental stress levels will be assessed using the PSS.
Cognitive Control and Flexibility Scale (CCFS)
Time frame: At baseline (single assessment at enrollment)
The CCFS will be used to assess parents' cognitive flexibility in stressful situations.
Impact on Family Scale (IPFAM)
Time frame: At baseline (single assessment at enrollment)
The level of disease-related impact on parents will be assessed using the IPFAM.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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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.
İpek Gürbüz, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy (DMD), run by Hacettepe University.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serenay Zorlu Develik, PhD Candidate (+90 546 665 33 11, serenayyzorlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Questionnaire for Children-PAQ-C (time frame: At baseline (single assessment at enrollment)). The study lists 23 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 29 Jan 2026.