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

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT03847298

Collaborator

(none)

Enrollment

Location

7.1

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker Physical Activity	Other: Physical activity and physical fitness assessment

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.

Study Design

Study Type:

Observational

Actual Enrollment :

48 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 19, 2017

Actual Primary Completion Date :

May 25, 2018

Actual Study Completion Date :

Jun 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Pacemaker	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.
Control	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.

Arm

Intervention/Treatment

Pacemaker

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.

Control

Other: Physical activity and physical fitness assessment

Outcome Measures

Primary Outcome Measures

Physical Activity Level [seven days]
Physical activity index will be measured using activity monitor for seven consecutive days.
Total Number of Steps [seven days]
Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
Munich Physical Fitness Test Score [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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sena Teber, Research Assistant, Hacettepe University

ClinicalTrials.gov Identifier:

NCT03847298

Other Study ID Numbers:

GO 17/880

First Posted:

Feb 20, 2019

Last Update Posted:

Feb 20, 2019

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sena Teber, Research Assistant, Hacettepe University

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Study Results

No Results Posted as of Feb 20, 2019