Clinical trial NCT03847298: Evaluation of Physical Fitness and Physical Activity Levels of Pediatric Arrhythmia Patients With Pacemaker
Official title: Evaluation of Physical Fitness and Physical Activity Levels of Pediatric Arrhythmia Patients With Pacemaker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker
Physical Activity
Keywords: pediatric
pacemaker
physical activity
physical fitness
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 48
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pacemakers who were followed routinely in Hacettepe Hospital, Department of Pediatric Cardiology.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Activity Level
timeFrame: seven days
measure: Total Number of Steps
timeFrame: seven days
measure: Munich Physical Fitness Test Score
timeFrame: 1st day (before using device)
Secondary outcomes:
measure: Functional exercise capacity (6 minutes walk test)
timeFrame: 1st day (before using device)
measure: Cardiorespiratory Capacity (maximal exercise test on the treadmill)
timeFrame: 8th day (last day of the assessment)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit and Hacettepe University Faculty of Medicine, Department of Pediatrics, Department of Pediatric Cardiology
Study officials:
References: