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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06349109
Other study ID # PA-WPW
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date May 1, 2025

Study information

Verified date April 2024
Source Karamanoglu Mehmetbey University
Contact Haluk Tekerlek, PhD
Phone +90-5355915009
Email haluktekerlek@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers
Gender All
Age group 7 Years to 18 Years
Eligibility 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 Design


Intervention

Other:
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.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 VO2peak Peak oxygen uptake 30-45 minutes
Secondary aPWV Arterial pulse wave velocity 15-20 minutes
Secondary GLS Global longitudinal strain for LV function 30-45 minutes
Secondary LASr Left atrial strain - Reservuar 30-45 minutes
Secondary LASct Left atrial strain - Contractile 30-45 minutes
Secondary LAScd Left atrial strain - Conduit 30-45 minutes
Secondary Physical activity barriers (Parent) scale score 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
Secondary Physical Activity Outcome Expectancies (Child) scale score 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
Secondary Physical Activity Home Environment (Child) scale score 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
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