Daily Physical Activity in Myelomeningocele

Completed

• Conditions: Physical Activity
• Interventions: Device: Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)

• Registration Number: NCT04186338
• Lead Sponsor: Marmara University

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).

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2017-04-01
• Study Completion: 2017-05-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-04
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)	age-, sex-, and body mass index-matched healthy controls
Patients with myelomeningocele	Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)	Patients diagnosed myelomeningocele with the neurological level between L5 and S3

Primary Outcome Measures

Name	Time	Method
Average Activity energy expenditure (AEE)	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 Outcome Measures

Name	Time	Method
Average physical activity durations	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.