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Completed

NCT Number: NCT03847298

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

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.

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Physical activity and physical fitness assessment

Other

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.

Primary outcomes

  1. Physical Activity Level

    Time frame: seven days

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

  2. Total Number of Steps

    Time frame: seven days

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

  3. 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

  1. Functional exercise capacity (6 minutes walk test)

    Time frame: 1st day (before using device)

    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.

  2. Cardiorespiratory Capacity (maximal exercise test on the treadmill)

    Time frame: 8th day (last day of the assessment)

    The symptom limited maximal exercise test will be performed without gas exchange measurement. The Modified Bruce Protocol will be applied on the treadmill.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2019
Registry last updated
Feb 20, 2019

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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