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Completed

NCT Number: NCT06349109

Physical Activity 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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiopulmonary exercise test

Other

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

Other

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

Other

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

Other

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

Physical Activity Barriers Assesment

Other

"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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. VO2peak

    Time frame: 30-45 minutes

    Peak oxygen uptake

  2. aPWV

    Time frame: 15-20 minutes

    Arterial pulse wave velocity

  3. GLS

    Time frame: 30-45 minutes

    Global longitudinal strain for LV function

  4. LASr

    Time frame: 30-45 minutes

    Left atrial strain - Reservuar

  5. LASct

    Time frame: 30-45 minutes

    Left atrial strain - Contractile

  6. LAScd

    Time frame: 30-45 minutes

    Left atrial strain - Conduit

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Karamanoğlu Mehmetbey University

Other

Registry information

Official study title

Physical Activity Level and Determinants in Children With Wolff-Parkinson-White Syndrome

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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