Wolff-Parkinson-White SyndromeNCT06349109
Physical Activity in Children With Wolff-Parkinson-White Syndrome
An observational study of Wolff-Parkinson-White Syndrome, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the level of physical activity and its determinants in children with WPW. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Wolff-Parkinson-White Syndrome
- What is being tested?
- Cardiopulmonary exercise test, Atrial-Ventricular Strain Analysis and Arterial Stiffness Measurement
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Dec 2024
- 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 7 to 18 years
- All sexes
- Child, Adult
Study population: Patients aged 7-18 years who are followed up by the Department of Paediatrics, Division of Paediatric Cardiology, Faculty of Medicine of a university will be included in the study.
Who may be able to join
- Being between 7-18 years old
- Ensuring clinical stability in patients
- No change in drug therapy, if any, that adversely affects clinical stability
Who cannot join
- Neurological and/or genetic musculoskeletal disorders
- Diagnosed orthopaedic and cognitive problems that prevent the tests from being performed
- History before 4 weeks of cardiac or other body system problems
- The patient and/or his/her family does not want to be included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity Level and Determinants in Children With Wolff-Parkinson-White Syndrome
The aim of this study was to investigate the level of physical activity and its determinants in children with WPW.
- Conditions
- Wolff-Parkinson-White Syndrome
- Being tested
- Cardiopulmonary exercise test, Atrial-Ventricular Strain Analysis, Arterial Stiffness Measurement, Physical Activity Level, Physical Activity Barriers Assesment
- Medical subject headings
- Wolff-Parkinson-White Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testOther
The cardiopulmonary exercise test (CPET), the gold standard for the assessment of cardiorespiratory fitness, will be used. The Modified Bruce/half Bruce protocol with will be used. In addition, dyspnoea, leg fatigue and general fatigue will be recorded every three minutes at rest, during the test and during the post-test recovery phases using the Modified Borg Scale and blood pressure will be recorded with a sphygmomanometer. The test will be continued until individuals reach the end of the protocol or until the last point at which they wish to stop the test. The test will be terminated if the patient wishes to terminate the test, severe breathlessness, leg fatigue or general fatigue, loss of coordination, progressive chest pain, ST segment elevation or depression of more than 2 mm, oxygen saturation of 80% or less, reaching 85% or more of the predicted heart rate. Oxygen consumption (VO2peak) will be used as the primary outcome measure for cardiorespiratory fitness.
Atrial-Ventricular Strain AnalysisOther
Atrial-Ventricular strain will be evaluated by a specialist physician using Speckle Tracking Echocardiography. During the evaluation, standard echocardiographic measurements will be made with transthoracic echocardiography. With these measurements, images suitable for strain analysis will be obtained. Deformation analysis will be performed using the speckle tracing method for the appropriate images obtained and hemodynamic parameters obtained by the analysis will be recorded.
Arterial Stiffness MeasurementOther
Arterial stiffness will be assessed using the pulse wave velocity (PWV) technique with the Mobile-O-GRAPH (TG) (LE.M., Stolberg, Germany), an oscillometer-based device. After the patients have rested sufficiently, measurements will be taken in an upright sitting position in a quiet and sufficiently bright environment at room temperature, with the device manso placed 2-3 cm above the chiibital fossa in the non-dominant upper limb and the arms raised to the level of the heart. Pulse propagation velocity will be calculated in m/sec with the help of a computer. A high velocity data indicates a high level of arterial stiffening and a low velocity data indicates a low level of arterial stiffening.
Physical Activity LevelOther
Physical activity level will be assessed with the Child Physical Activity Questionnaire.
Physical Activity Barriers AssesmentOther
"Physical Activity Outcome Expectancies (child survey)" and "Physical Activity Home Environment Scale (Child)" will be used in children, while " Physical activity barriers (Parent)" will be used in family members.
| Study group | Role | What they receive |
|---|---|---|
| WPW group | Not described Receives: Other: Cardiopulmonary exercise test; Other: Atrial-Ventricular Strain Analysis; Other: Arterial Stiffness Measurement; Other: Physical Activity Level; Other: Physical Activity Barriers Assesment | |
| Control Group | Not described Receives: Other: Physical Activity Level; Other: Physical Activity Barriers Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Physical Activity Questionnaire for Older Children Score
The PAQ-C comprises ten items and higher scores indicate a higher level of activity. The first item of the PAQ-C consists of 22 common sports and leisure activities for which the participants select the score based on the frequency of the activity performed during the preceding seven days on a five-point rating scale, after which a mean composite score was calculated. The remaining eight items address physical activities performed during the day, for example, physical education classes, recess time, lunchtime, as well as afterschool activities on weekday evenings and weekends, and finally a summary for all days of the week. The mean score of the first nine items is the summary score of the PAQ-C. The tenth item inquires about any unusual circumstances (e.g., sickness) that affected/prevented the child's physical activity in the seven days preceding the assessment.
Measured: 15-20 mins
Secondary outcomes (9)
VO2peak
Peak oxygen uptake
Measured: 30-45 minutes
aPWV
Arterial pulse wave velocity
Measured: 15-20 minutes
GLS
Global longitudinal strain for LV function
Measured: 30-45 minutes
LASr
Left atrial strain - Reservuar
Measured: 30-45 minutes
LASct
Left atrial strain - Contractile
Measured: 30-45 minutes
LAScd
Left atrial strain - Conduit
Measured: 30-45 minutes
Physical activity barriers (Parent) scale score
The original scale consists of 13 items and two dimensions. The Turkish adapted version of the scale consists of two dimensions and 11 items. Items 1-6 in the scale constitute the "Environmental barriers" sub-dimension and items 7-11 constitute the "Personal barriers" sub-dimension. Total scores are obtained separately for the two sub-dimensions of the scale. The score range varies between 6 (min) and 30 (max) for the "Environmental barriers" sub-dimension and between 5 (min) and 25 (max) for the "Personal barriers" sub-dimension. The higher score in the sub-dimensions indicates the magnitude of the barriers to physical activity in those areas for the participant.
Measured: 15-20 minutes
Physical Activity Outcome Expectancies (Child) scale score
The scale is a three-point Likert-type scale consisting of 17 items and two dimensions. The "Negative outcome expectancies" sub-dimension of the scale consists of items 2, 3, 4, 6, 7, 11, 12, 14 and 16 and the "Positive outcome expectancies" sub-dimension consists of items 1, 5, 8, 9, 10, 13, 15 and 17. Total scores are obtained separately for the two dimensions. The score that can be obtained from the 9 items related to the negative outcome expectancies sub-dimension varies between 9 and 17. The score that can be obtained from 8 items related to the positive outcome expectancy sub-dimension varies between 8 and 24. A high score in the negative outcome expentancies sub-dimension indicates an excess of negative expectations about physical activity. A high score on the Positive Outcome Expentancies sub-dimension indicates an excess of positive expectations about physical activity.
Measured: 15-20 minutes
Physical Activity Home Environment (Child) scale score
The scale is a triple likert type scale consisting of 5 items. - The score range of the scale is 5-15. - A high score on the scale indicates that the family supports the child to be more physically active.
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wolff-Parkinson-White SyndromeStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haluk Tekerlek, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349109
- Sponsor's protocol ID
- PA-WPW
- Status last verified
- Jan 2025
- First submitted
- 30 Mar 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Level and Determinants in Children With Wolff-Parkinson-White Syndrome
- ClinicalTrials.gov ID
- NCT06349109
- Acronym / sponsor ID
- PA-WPW
- Conditions
- Wolff-Parkinson-White Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 5 Apr 2024 (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.
The aim of this study was to investigate the level of physical activity and its determinants in children with WPW.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WPW group | – | Other: Cardiopulmonary exercise test, Other: Atrial-Ventricular Strain Analysis, Other: Arterial Stiffness Measurement, Other: Physical Activity Level, Other: Physical Activity Barriers Assesment |
| Control Group | – | Other: Physical Activity Level, Other: Physical Activity Barriers Assesment |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients aged 7-18 years who are followed up by the Department of Paediatrics, Division of Paediatric Cardiology, Faculty of Medicine of a university will be included in the study.
Key inclusion criteria (3 listed)
- Being between 7-18 years old
- Ensuring clinical stability in patients
- No change in drug therapy, if any, that adversely affects clinical stability
Key exclusion criteria (4 listed)
- Neurological and/or genetic musculoskeletal disorders
- Diagnosed orthopaedic and cognitive problems that prevent the tests from being performed
- History before 4 weeks of cardiac or other body system problems
- The patient and/or his/her family does not want to be included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testThe cardiopulmonary exercise test (CPET), the gold standard for the assessment of cardiorespiratory fitness, will be used. The Modified Bruce/half Bruce protocol with will be used. In addition, dyspnoea, leg fatigue and general fatigue will be recorded every three minutes at rest, during the test and during the post-test recovery phases using the Modified Borg Scale and blood pressure will be recorded with a sphygmomanometer. The test will be continued until individuals reach the end of the protocol or until the last point at which they wish to stop the test. The test will be terminated if the patient wishes to terminate the test, severe breathlessness, leg fatigue or general fatigue, loss of coordination, progressive chest pain, ST segment elevation or depression of more than 2 mm, oxygen saturation of 80% or less, reaching 85% or more of the predicted heart rate. Oxygen consumption (VO2peak) will be used as the primary outcome measure for cardiorespiratory fitness. | Other | WPW group |
| Atrial-Ventricular Strain AnalysisAtrial-Ventricular strain will be evaluated by a specialist physician using Speckle Tracking Echocardiography. During the evaluation, standard echocardiographic measurements will be made with transthoracic echocardiography. With these measurements, images suitable for strain analysis will be obtained. Deformation analysis will be performed using the speckle tracing method for the appropriate images obtained and hemodynamic parameters obtained by the analysis will be recorded. | Other | WPW group |
| Arterial Stiffness MeasurementArterial stiffness will be assessed using the pulse wave velocity (PWV) technique with the Mobile-O-GRAPH (TG) (LE.M., Stolberg, Germany), an oscillometer-based device. After the patients have rested sufficiently, measurements will be taken in an upright sitting position in a quiet and sufficiently bright environment at room temperature, with the device manso placed 2-3 cm above the chiibital fossa in the non-dominant upper limb and the arms raised to the level of the heart. Pulse propagation velocity will be calculated in m/sec with the help of a computer. A high velocity data indicates a high level of arterial stiffening and a low velocity data indicates a low level of arterial stiffening. | Other | WPW group |
| Physical Activity LevelPhysical activity level will be assessed with the Child Physical Activity Questionnaire. | Other | Control Group, WPW group |
| Physical Activity Barriers Assesment"Physical Activity Outcome Expectancies (child survey)" and "Physical Activity Home Environment Scale (Child)" will be used in children, while " Physical activity barriers (Parent)" will be used in family members. | Other | Control Group, WPW group |
Primary outcome
The Physical Activity Questionnaire for Older Children Score
Time frame: 15-20 mins
The PAQ-C comprises ten items and higher scores indicate a higher level of activity. The first item of the PAQ-C consists of 22 common sports and leisure activities for which the participants select the score based on the frequency of the activity performed during the preceding seven days on a five-point rating scale, after which a mean composite score was calculated. The remaining eight items address physical activities performed during the day, for example, physical education classes, recess time, lunchtime, as well as afterschool activities on weekday evenings and weekends, and finally a summary for all days of the week. The mean score of the first nine items is the summary score of the PAQ-C. The tenth item inquires about any unusual circumstances (e.g., sickness) that affected/prevented the child's physical activity in the seven days preceding the assessment.
9 secondary outcomes
VO2peak
Time frame: 30-45 minutes
aPWV
Time frame: 15-20 minutes
GLS
Time frame: 30-45 minutes
LASr
Time frame: 30-45 minutes
LASct
Time frame: 30-45 minutes
LAScd
Time frame: 30-45 minutes
Physical activity barriers (Parent) scale score
Time frame: 15-20 minutes
Physical Activity Outcome Expectancies (Child) scale score
Time frame: 15-20 minutes
Physical Activity Home Environment (Child) scale score
Time frame: 15-20 minutes
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 29 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Wolff-Parkinson-White Syndrome, run by Karamanoğlu Mehmetbey 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 3 inclusion and 4 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 29 Jan 2025. 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?
The Physical Activity Questionnaire for Older Children Score (time frame: 15-20 mins). 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 2025.