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

19. februar 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

48

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia
      • Ankara, Tyrkia
        • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

7 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Styre
Annen: 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.
Pacemaker
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical Activity Level
Tidsramme: seven days
Physical activity index will be measured using activity monitor for seven consecutive days.
seven days
Total Number of Steps
Tidsramme: seven days
Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.
seven days
Munich Physical Fitness Test Score
Tidsramme: 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).
1st day (before using device)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functional exercise capacity (6 minutes walk test)
Tidsramme: 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.
1st day (before using device)
Cardiorespiratory Capacity (maximal exercise test on the treadmill)
Tidsramme: 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.
8th day (last day of the assessment)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hacettepe University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. november 2017

Primær fullføring (Faktiske)

25. mai 2018

Studiet fullført (Faktiske)

24. juni 2018

Datoer for studieregistrering

Først innsendt

4. januar 2019

Først innsendt som oppfylte QC-kriteriene

19. februar 2019

Først lagt ut (Faktiske)

20. februar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. februar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. februar 2019

Sist bekreftet

1. februar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GO 17/880

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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