Evaluation of Physical Fitness and Physical Activity Levels of Pediatric Arrhythmia Patients With Pacemaker
19. februar 2019 opdateret af: Sena Teber, Hacettepe University
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
48
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ankara, Kalkun
- 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
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
7 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients with pacemakers who were followed routinely in Hacettepe Hospital, Department of Pediatric Cardiology.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Styring
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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.
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Pacemaker
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Physical Activity Level
Tidsramme: seven days
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Physical activity index will be measured using activity monitor for seven consecutive days.
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seven days
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Total Number of Steps
Tidsramme: seven days
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Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
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seven days
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Munich Physical Fitness Test Score
Tidsramme: 1st day (before using device)
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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).
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1st day (before using device)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional exercise capacity (6 minutes walk test)
Tidsramme: 1st day (before using device)
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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.
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1st day (before using device)
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Cardiorespiratory Capacity (maximal exercise test on the treadmill)
Tidsramme: 8th day (last day of the assessment)
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The symptom limited maximal exercise test will be performed without gas exchange measurement.
The Modified Bruce Protocol will be applied on the treadmill.
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8th day (last day of the assessment)
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Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. november 2017
Primær færdiggørelse (Faktiske)
25. maj 2018
Studieafslutning (Faktiske)
24. juni 2018
Datoer for studieregistrering
Først indsendt
4. januar 2019
Først indsendt, der opfyldte QC-kriterier
19. februar 2019
Først opslået (Faktiske)
20. februar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. februar 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GO 17/880
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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