Daily Physical Activity in Myelomeningocele

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186338
• Other study ID #: 09.2017.168
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: December 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Meningomyelocele
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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