- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06349109
Physical Activity in Children With Wolff-Parkinson-White Syndrome
January 28, 2025 updated by: Haluk Tekerlek, Karamanoğlu Mehmetbey University
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Being between 7-18 years old
- Ensuring clinical stability in patients
- No change in drug therapy, if any, that adversely affects clinical stability
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control Group
|
Physical activity level will be assessed with the Child Physical Activity Questionnaire.
"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.
|
|
WPW group
|
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 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 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 will be assessed with the Child Physical Activity Questionnaire.
"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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
15-20 mins
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VO2peak
Time Frame: 30-45 minutes
|
Peak oxygen uptake
|
30-45 minutes
|
|
aPWV
Time Frame: 15-20 minutes
|
Arterial pulse wave velocity
|
15-20 minutes
|
|
GLS
Time Frame: 30-45 minutes
|
Global longitudinal strain for LV function
|
30-45 minutes
|
|
LASr
Time Frame: 30-45 minutes
|
Left atrial strain - Reservuar
|
30-45 minutes
|
|
LASct
Time Frame: 30-45 minutes
|
Left atrial strain - Contractile
|
30-45 minutes
|
|
LAScd
Time Frame: 30-45 minutes
|
Left atrial strain - Conduit
|
30-45 minutes
|
|
Physical Activity Outcome Expectancies (Child) scale score
Time Frame: 15-20 minutes
|
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.
|
15-20 minutes
|
|
Physical Activity Home Environment (Child) scale score
Time Frame: 15-20 minutes
|
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.
|
15-20 minutes
|
|
Physical activity barriers (Parent) scale score
Time Frame: 15-20 minutes
|
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.
|
15-20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Actual)
December 1, 2024
Study Completion (Actual)
December 1, 2024
Study Registration Dates
First Submitted
March 30, 2024
First Submitted That Met QC Criteria
March 30, 2024
First Posted (Actual)
April 5, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 28, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Cardiac Conduction System Disease
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Disease
- Arrhythmias, Cardiac
- Neurodegenerative Diseases
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Heart Defects, Congenital
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Pre-Excitation Syndromes
- Syndrome
- Parkinson Disease
- Wolff-Parkinson-White Syndrome
Other Study ID Numbers
- PA-WPW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wolff-Parkinson-White Syndrome
-
IRCCS Ospedale San RaffaeleNot yet recruitingAtrioventricular Reentrant Tachycardias | Wolff-Parkinson-White (WPW) Syndrome
-
University of Sao Paulo General HospitalInCor Heart InstituteCompletedCardiac Arrhythmias | Accessory Pathway | Wolf Parkinson White SyndromeBrazil
-
United States Naval Medical Center, San DiegoActive, not recruitingCardiac Death | Cardiac Death, Sudden | Wolf Parkinson White SyndromeUnited States
-
Karolinska University HospitalCompletedWolff-Parkinson-White SyndromeSweden
-
Ain Shams UniversityRecruitingWolf Parkinson White Syndrome | ArrythmiasEgypt
-
Sykehuset TelemarkOslo University HospitalCompletedAtrial Fibrillation | Atrial Flutter | Wolff-Parkinson-White Syndrome | Pre-excitation Syndromes | Paroxysmal TachycardiaNorway
-
Nantes University HospitalTerminatedWolff-Parkinson-White SyndromeFrance
-
Christian BalmerTerminatedSudden Cardiac Death | Wolff-Parkinson-White Syndrome | Risk StratificationSwitzerland
-
Assiut UniversityNot yet recruitingWolff-Parkinson-White Syndrome
-
Centre Hospitalier Universitaire DijonRecruitingPeople With White Sutton SyndromeFrance
Clinical Trials on Cardiopulmonary exercise test
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingFabry Disease | Fabry Disease, Cardiac VariantNetherlands
-
University of HullSheffield Hallam UniversityTerminated
-
Virginia Commonwealth UniversityNovartis PharmaceuticalsCompletedPrior Acute Myocardial Infarction | Evidence of Systemic Inflammation (C Reactive Protein Plasma >2 mg/l) | Reduced Left Ventricle Ejection Fraction (<50%) | Symptoms of Heart Failure (NYHA Class II-III)United States
-
Hasselt UniversityCompletedCoronary Artery Bypass SurgeryBelgium
-
The Clatterbridge Cancer Centre NHS Foundation...University of Liverpool Cancer Research CentreNot yet recruiting
-
York Teaching Hospitals NHS Foundation TrustUniversity of York; York St John UniversityCompletedInflammatory Response | Immune SystemUnited Kingdom
-
Bezmialem Vakif UniversityCompleted
-
Chang Gung Memorial HospitalCompletedComorbid Chronic Lung Disease on Heart Failure
-
Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia | Pulmonary Arteriovenous MalformationsUnited Kingdom
-
Wissenschaftliches Institut Bethanien e.VRoche Pharma AGCompleted