Daily Physical Activity in Myelomeningocele

Sponsor

Marmara University (Other)

Overall Status

Completed

CT.gov ID

NCT04186338

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity	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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	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.

Arm

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)

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Marmara University

Investigators

Principal Investigator: Kardelen Gencer Atalay, Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kardelen Gencer Atalay, Principal Investigator, Marmara University

ClinicalTrials.gov Identifier:

NCT04186338

Other Study ID Numbers:

09.2017.168

First Posted:

Dec 4, 2019

Last Update Posted:

Dec 6, 2019

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kardelen Gencer Atalay, Principal Investigator, Marmara University

Activity energy expenditure

Moderate to vigorous physical activity

Myelomeningocele

Additional relevant MeSH terms:

Meningomyelocele

Spina Bifida Cystica

Study Results

No Results Posted as of Dec 6, 2019