Physical Activity in Children With Wolff-Parkinson-White Syndrome
Physical Activity Level and Determinants in Children With Wolff-Parkinson-White Syndrome
1 other identifier
observational
26
1 country
1
Brief Summary
The aim of this study was to investigate the level of physical activity and its determinants in children with WPW.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 30, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 29, 2025
January 1, 2025
9 months
March 30, 2024
January 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
15-20 mins
Secondary Outcomes (9)
VO2peak
30-45 minutes
aPWV
15-20 minutes
GLS
30-45 minutes
LASr
30-45 minutes
LASct
30-45 minutes
- +4 more secondary outcomes
Study Arms (2)
WPW group
Control Group
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Being between 7-18 years old
- Ensuring clinical stability in patients
- No change in drug therapy, if any, that adversely affects clinical stability
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research assistant, PhD
Study Record Dates
First Submitted
March 30, 2024
First Posted
April 5, 2024
Study Start
March 1, 2024
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
January 29, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share