Daily Physical Activity in Myelomeningocele

NCT04186338 | Completed

• 1 other identifier: 09.2017.168
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physical Activity

Keywords

Activity energy expenditure; Moderate to vigorous physical activity; Myelomeningocele

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Average physical activity durations

  After wearing monitors for five consecutive days

Study Arms (2)

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)

Healthy controls

age-, sex-, and body mass index-matched healthy controls

Device: Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)

Interventions

Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics) DEVICE

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; Patients with myelomeningocele

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Related Publications (1)

• 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.

  PMID: 32748658 DERIVED

MeSH Terms

Conditions

Motor Activity; Meningomyelocele

Condition Hierarchy (Ancestors)

Behavior; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kardelen Gencer Atalay

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: December 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 6, 2019

Record last verified: 2019-12