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

NCT03847298 | Completed

• 1 other identifier: GO 17/880
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker; Physical Activity

Keywords

pediatric; pacemaker; physical activity; physical fitness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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 Arms (2)

Pacemaker

Other: Physical activity and physical fitness assessment

Control

Other: Physical activity and physical fitness assessment

Interventions

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.

Control; Pacemaker

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with pacemakers who were followed routinely in Hacettepe Hospital, Department of Pediatric Cardiology.

You may qualify if:

• Permanent pacemaker
• Being 7-18 years of age
• Able and willing to complete the informed consent process
• Able to walk and co-operate

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

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)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: February 20, 2019
• Study Start: November 19, 2017
• Primary Completion: May 25, 2018
• Study Completion: June 24, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

TU (1)