Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Daily Physical Activity in Myelomeningocele

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04186338
Recruitment Status : Completed
First Posted : December 4, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Kardelen Gencer Atalay, 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.

Condition or disease Intervention/treatment
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).

Layout table for study information
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 : December 1, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : May 1, 2017


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186338


Sponsors and Collaborators
Marmara University
Investigators
Layout table for investigator information
Principal Investigator: Kardelen Gencer Atalay Marmara University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kardelen Gencer Atalay, Principal Investigator, Marmara University
ClinicalTrials.gov Identifier: NCT04186338    
Other Study ID Numbers: 09.2017.168
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kardelen Gencer Atalay, Marmara University:
Activity energy expenditure
Moderate to vigorous physical activity
Myelomeningocele
Additional relevant MeSH terms:
Layout table for MeSH terms
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Spinal Dysraphism