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Daily Physical Activity in Myelomeningocele

4. december 2019 opdateret af: Kardelen Gencer Atalay, Marmara University

Daily Physical Activity in Children and Adolescents With Low Lumbar and Sacral Level Myelomeningocele

Obesity is getting more common and challenging to treat in children and adolescents with myelomeningocele. Therefore, it is becoming more important to determine daily physical activity in these patients. Daily walking performance and average steps per day in patients with low lumbar and sacral level myelomeningocele are shown to not differ from healthy controls. Step counts can not reflect all torsional accelerations associated with daily living activities. Omnidirectional accelerometers provide all types of body movement outputs and give detailed parameters of physical activity level and energy expenditure. There is no data about energy expenditure and physical activity level of the patients with myelomeningocele in daily routine. This study aims to quantify energy expenditure and physical activity of children and adolescents with low lumbar and sacral level myelomeningocele.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Children and adolescents with low lumbar and sacral level myelomeningocele, and age-, sex-, and BMI-matched controls were included. Omnidirectional accelerometer monitor (Actical®) was used to assess activity energy expenditure and daily durations spent in sedentary, light activity and moderate to vigorous physical activity (MVPA).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

20

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

6 år til 16 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Children and adolescents with low lumbar and sacral level myelomeningocele and their age-, sex-, and body mass index (BMI)-matched healthy peers were included.

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed myelomeningocele with the neurological level between L5 and S3
  • Patients aged between 6 and 16 years
  • Independent ambulatory patients without an assistive device or braces

Exclusion Criteria:

  • Presence of disorders other than myelomeningocele that affect physical activity or exercise (e.g. rheumatic disease, cardiovascular disease)
  • Unable to wear omnidirectional accelerometer monitor (Actical®, Philips Respironics) for five consecutive days

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
Patients with myelomeningocele
Patients diagnosed myelomeningocele with the neurological level between L5 and S3
Enhed: Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)
All participants were instructed to wear monitors for five consecutive days except during water-based activities. Data for each participant was collected to ensure included three valid weekdays. Daily activity energy expenditure (kcal/kg/min), and sedentary, light, moderate and vigorous levels (min) were examined using a software program.
Healthy controls
age-, sex-, and body mass index-matched healthy controls
Enhed: Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)
All participants were instructed to wear monitors for five consecutive days except during water-based activities. Data for each participant was collected to ensure included three valid weekdays. Daily activity energy expenditure (kcal/kg/min), and sedentary, light, moderate and vigorous levels (min) were examined using a software program.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average Activity energy expenditure (AEE)
Tidsramme: After wearing monitors for five consecutive days
Activity energy expenditure (AEE) (kcal/kg/min) refers to thermogenesis from all activities associated with daily living. An average amount of three valid weekdays will be calculated.
After wearing monitors for five consecutive days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average physical activity durations
Tidsramme: After wearing monitors for five consecutive days
The sedentary level (min) is the total amount of time when AEE below 0.01 kcal/kg/min. The light level is the total amount of time when AEE between 0.01 and 0.04 kcal/kg/min. The moderate level is the total amount of time when AEE between 0.04 and 0.10 kcal/kg/min. The vigorous level (min) is the total amount of time when AEE above 0.10 kcal/kg/min.
After wearing monitors for five consecutive days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Marmara University

Efterforskere

  • Ledende efterforsker: Kardelen Gencer Atalay, Marmara University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. december 2016

Primær færdiggørelse (Faktiske)

1. april 2017

Studieafslutning (Faktiske)

1. maj 2017

Datoer for studieregistrering

Først indsendt

2. december 2019

Først indsendt, der opfyldte QC-kriterier

2. december 2019

Først opslået (Faktiske)

4. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09.2017.168

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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