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Daily Physical Activity in Myelomeningocele

NCT ID: NCT04186338

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-05-01

Brief Summary

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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

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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).

Conditions

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Physical Activity

Keywords

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Activity energy expenditure Moderate to vigorous physical activity Myelomeningocele

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with myelomeningocele

Patients diagnosed myelomeningocele with the neurological level between L5 and S3

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

Intervention Type 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

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

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Kardelen Gencer Atalay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kardelen Gencer Atalay

Role: PRINCIPAL_INVESTIGATOR

Marmara University

References

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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.

Reference Type DERIVED
PMID: 32748658 (View on PubMed)

Other Identifiers

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09.2017.168

Identifier Type: -

Identifier Source: org_study_id