Evaluation of Physical Fitness and Physical Activity Levels of Pediatric Arrhythmia Patients With Pacemaker

Study Overview
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Brief Summary
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The aim of this study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia patients with pacemaker compared with their healthy peers.

Detailed Description
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Studies in children with heart diseases suggest that physical activity levels are reduced relative to their peers, which in turn increases cardiovascular risk factors and cardiac rhythm problems. To the best of our knowledge, physical fitness and objectively measured physical activity levels of children with a pacemaker have not been studied. The aim of this study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia patients with a pacemaker compared with their healthy peers. Investigators enrolled clinically stable pediatric patients and used the echocardiogram to evaluate cardiac functions of all patients. Physical fitness was assessed using the Munich Physical Fitness Test (MFT). The SenseWear Armband metabolic Holter device was used to record the physical activity level for consecutive 7 days.

Official Title
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Evaluation of Physical Fitness and Physical Activity Levels of Pediatric Arrhythmia Patients With Pacemaker

Conditions
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Pacemaker, Physical Activity

Intervention / Treatment
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* Other: Physical activity and physical fitness assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria of the Pacemaker Group: Permanent pacemaker Being 7-18 years of age Able and willing to complete the informed consent process Able to walk and co-operate Exclusion Criteria: Exclusion criteria of Pacemaker Group: Unstable medical condition To have severe neurological, severe orthopedic problems To have severe heart failure and another systemic disease or acute infection Down Syndrome The control group will consist of healthy subjects.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pacemaker<br> | Other: Physical activity and physical fitness assessment<br>* Physical fitness was assessed using Munich Physical Fitness Test (MFT). The SenseWear Armband metabolic holter device was used to record the physical activity level for consecutive 7 days. The functional exercise capacity of the individuals was assessed by the six-minute walking test (6MWT) and cardiorespiratory capacity was assessed by maximal exercise test on the treadmill.<br>|
| Control<br> | Other: Physical activity and physical fitness assessment<br>* Physical fitness was assessed using Munich Physical Fitness Test (MFT). The SenseWear Armband metabolic holter device was used to record the physical activity level for consecutive 7 days. The functional exercise capacity of the individuals was assessed by the six-minute walking test (6MWT) and cardiorespiratory capacity was assessed by maximal exercise test on the treadmill.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Level | Physical activity index will be measured using activity monitor for seven consecutive days. | seven days | 
| Total Number of Steps | Participants will wear an accelerometer (physical activity monitor) for seven consecutive days. | seven days | 
| Munich Physical Fitness Test Score | The test consists of six different parameters, including balancing and bouncing (speed and coordination), accurate throw (speed and coordination), trunk flexibility, vertical jumping (power), hanging (endurance and strength), and step test (endurance, speed and coordination). After all the parameters are completed, the score of each parameter is calculated from the standardization chart according to age and sex. This total score is divided by the number of parameters and recorded as Munich total score. Physical fitness is classified according to scores as deficient (<35), normal (36-45), satisfactory (46-55), good (56-65) and very good (>66). | 1st day (before using device) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional exercise capacity (6 minutes walk test) | 6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded. | 1st day (before using device) | 
| Cardiorespiratory Capacity (maximal exercise test on the treadmill) | The symptom limited maximal exercise test will be performed without gas exchange measurement. The Modified Bruce Protocol will be applied on the treadmill. | 8th day (last day of the assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, pacemaker, physical activity, physical fitness