Skip to main content
Clinical Trials/NCT03847298
NCT03847298
Completed
N/A

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

Hacettepe University1 site in 1 country48 target enrollmentNovember 19, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pacemaker
Sponsor
Hacettepe University
Enrollment
48
Locations
1
Primary Endpoint
Physical Activity Level
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 19, 2017
End Date
June 24, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sena Teber

Research Assistant

Hacettepe University

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.

Outcomes

Primary Outcomes

Physical Activity Level

Time Frame: seven days

Physical activity index will be measured using activity monitor for seven consecutive days.

Total Number of Steps

Time Frame: seven days

Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.

Munich Physical Fitness Test Score

Time Frame: 1st day (before using device)

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).

Secondary Outcomes

  • Functional exercise capacity (6 minutes walk test)(1st day (before using device))
  • Cardiorespiratory Capacity (maximal exercise test on the treadmill)(8th day (last day of the assessment))

Study Sites (1)

Loading locations...

Similar Trials