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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03847298
Enrollment
48
Registered
2019-02-20
Start date
2017-11-19
Completion date
2018-06-24
Last updated
2019-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacemaker, Physical Activity

Keywords

pediatric, pacemaker, physical activity, physical fitness

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.

Interventions

OTHERPhysical activity and physical fitness assessment

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.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Physical Activity Levelseven daysPhysical activity index will be measured using activity monitor for seven consecutive days.
Total Number of Stepsseven daysParticipants will wear an accelerometer (physical activity monitor) for seven consecutive days.
Munich Physical Fitness Test Score1st 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

MeasureTime frameDescription
Functional exercise capacity (6 minutes walk test)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.
Cardiorespiratory Capacity (maximal exercise test on the treadmill)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026