Daily Physical Activity in 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.

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Key information

Conditions

Physical Activity Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Meningomyelocele Motor Activity Nervous System Diseases Nervous System Malformations Neural Tube Defects

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)

Device

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.

Primary outcomes

Average Activity energy expenditure (AEE)

Time frame: 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.

Secondary outcomes

Average physical activity durations

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Dec 4, 2019
Registry last updated: Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed