Daily Physical Activity in Myelomeningocele

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Device: Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)

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).

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with myelomeningocele; Patients diagnosed myelomeningocele with the neurological level between L5 and S3	Device: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Activity energy expenditure (AEE)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average physical activity durations	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

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Kardelen Gencer Atalay, Marmara University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Myelomeningocele; Activity energy expenditure; Moderate to vigorous physical activity
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism; Meningomyelocele; Spina Bifida Cystica
• Other Study ID Numbers: 09.2017.168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No