Physical Activity in Children With Wolff-Parkinson-White Syndrome
NCT ID: NCT06349109
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
26 participants
OBSERVATIONAL
2024-03-01
2024-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exercise Capacity Muscle Oxygenation and Arterial Stiffness in Children With Pulmonary Arterial Hypertension
NCT06454838
Effectiveness of Cardiopulmonary Exercises for Children With Pectus Excavatum
NCT07300748
Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
NCT03295201
Chest Physiotherapy and Aerobic Training in Children Post Abdominal Surgery
NCT06653764
Exercise Training in Children With Corrective Cardiac Surgeries
NCT05763238
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
WPW group
Cardiopulmonary exercise test
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 Analysis
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 Measurement
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 Level
Physical activity level will be assessed with the Child Physical Activity Questionnaire.
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.
Control Group
Physical Activity Level
Physical activity level will be assessed with the Child Physical Activity Questionnaire.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cardiopulmonary exercise test
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 Analysis
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 Measurement
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 Level
Physical activity level will be assessed with the Child Physical Activity Questionnaire.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ensuring clinical stability in patients
* No change in drug therapy, if any, that adversely affects clinical stability
Exclusion Criteria
* 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
7 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karamanoğlu Mehmetbey University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Haluk Tekerlek
Research assistant, PhD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hacettepe University
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PA-WPW
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.