Physical ActivityNCT04186338
Daily Physical Activity in Myelomeningocele
An observational study of Physical Activity, run by Marmara University.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Daily Physical Activity in Children and Adolescents With Low Lumbar and Sacral Level Myelomeningocele
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.
Read the 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).
- Conditions
- Physical Activity
- Being tested
- Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)
- Keywords
- Activity energy expenditure, Moderate to vigorous physical activity, Myelomeningocele
- Medical subject headings
- Motor Activity, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with myelomeningocele | Patients diagnosed myelomeningocele with the neurological level between L5 and S3 Receives: Device: Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics) | |
| Healthy controls | age-, sex-, and body mass index-matched healthy controls Receives: Device: Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After wearing monitors for five consecutive days
Secondary outcomes (1)
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.
Measured: After wearing monitors for five consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Dec 2016
- Primary completion1 Apr 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kardelen Gencer Atalay, Marmara University
- Investigators
- Kardelen Gencer Atalay, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186338
- Sponsor's protocol ID
- 09.2017.168
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32748658
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Physical Activity in Children and Adolescents With Low Lumbar and Sacral Level Myelomeningocele
- ClinicalTrials.gov ID
- NCT04186338
- Acronym / sponsor ID
- 09.2017.168
- Conditions
- Physical Activity
- Keywords
- Activity energy expenditure, Moderate to vigorous physical activity, Myelomeningocele
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with myelomeningocele | – | Device: Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)Patients diagnosed myelomeningocele with the neurological level between L5 and S3 |
| Healthy controls | – | Device: Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)age-, sex-, and body mass index-matched healthy controls |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Healthy controls, Patients with myelomeningocele |
Primary outcome
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.
1 secondary outcome
Average physical activity durations
Time frame: After wearing monitors for five consecutive days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Derived from this study: PubMed 32748658Gencer-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kardelen Gencer Atalay principal investigator
Marmara University
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Activity energy expenditure (AEE) (time frame: After wearing monitors for five consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.