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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847298
• Other study ID #: GO 17/880
• Status: Completed
• Start date: November 19, 2017
• Est. completion date: June 24, 2018

Study information

• Verified date: February 2019
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 24, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pacemaker
• Physical Activity

Intervention

Other:
• Physical 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.

Locations

Country	Name	City	State
Turkey	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

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Level	Physical activity index will be measured using activity monitor for seven consecutive days.	seven days
Primary	Total Number of Steps	Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.	seven days
Primary	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	Functional exercise capacity (6 minutes walk test)	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.	1st day (before using device)
Secondary	Cardiorespiratory Capacity (maximal exercise test on the treadmill)	The symptom limited maximal exercise test will be performed without gas exchange measurement. The Modified Bruce Protocol will be applied on the treadmill.	8th day (last day of the assessment)