Clinical trial NCT04186338: Daily Physical Activity in Myelomeningocele
Official title: Daily Physical Activity in Children and Adolescents With Low Lumbar and Sacral Level Myelomeningocele
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: Activity energy expenditure
Moderate to vigorous physical activity
Myelomeningocele
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescents with low lumbar and sacral level myelomeningocele and their age-, sex-, and body mass index (BMI)-matched healthy peers were included.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Average Activity energy expenditure (AEE)
timeFrame: After wearing monitors for five consecutive days
Secondary outcomes:
measure: Average physical activity durations
timeFrame: After wearing monitors for five consecutive days
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University
name: Kardelen Gencer Atalay
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gencer-Atalay K, Karadag-Saygi E, Uzuncakmak B, Keskin A, Furtun Y, Guven H, Uzunoglu I, Kurtel H. Daily Physical Activity in Children and Adolescents with Low Lumbar and Sacral Level Myelomeningocele. Dev Neurorehabil. 2021 Apr;24(3):145-149. doi: 10.1080/17518423.2020.1800855. Epub 2020 Aug 4.