NCT06349109

Brief Summary

The aim of this study was to investigate the level of physical activity and its determinants in children with WPW.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

March 30, 2024

Last Update Submit

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

Other: Cardiopulmonary exercise testOther: Atrial-Ventricular Strain AnalysisOther: Arterial Stiffness MeasurementOther: Physical Activity LevelOther: Physical Activity Barriers Assesment

Control Group

Other: Physical Activity LevelOther: Physical Activity Barriers Assesment

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.

WPW group

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.

WPW group

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.

WPW group

Physical activity level will be assessed with the Child Physical Activity Questionnaire.

Control GroupWPW group

"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 GroupWPW group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

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)

Location

MeSH Terms

Conditions

Wolff-Parkinson-White Syndrome

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pre-Excitation SyndromesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

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

Locations