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

• ClinicalTrials.gov Identifier: NCT03847298
• Recruitment Status: Completed
• First Posted: February 20, 2019
• Last Update Posted: February 20, 2019
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Sena Teber, Hacettepe University

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
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: November 19, 2017
• Actual Primary Completion Date: May 25, 2018
• Actual Study Completion Date: June 24, 2018

Groups and Cohorts

Group/Cohort	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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

Criteria

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

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, Turkey

Sponsors and Collaborators

Hacettepe University

More Information

• Responsible Party: Sena Teber, Research Assistant, Hacettepe University
• ClinicalTrials.gov Identifier: NCT03847298
• Other Study ID Numbers: GO 17/880
• First Posted: February 20, 2019
• Last Update Posted: February 20, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sena Teber, Hacettepe University:

pediatric; pacemaker; physical activity; physical fitness

Additional relevant MeSH terms:

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes