Assess Whether Knowledge by the Younger of the Function of the Accelerometer Determines Its Amount of Physical Activity

Physical Activity Clinical Trial

— ACCELORIX2  

Official title:

Assess Whether Knowledge by the Children and Adolescents of the Function of the Accelerometer Determines Its Amount of Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844101
• Other study ID #: 2012_29
• Secondary ID: 2012-A01647-36
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: October 26, 2016
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded and the non-blinded group. The blinded subjects will be informed that we were testing the reliability of a new device for body posture assessment and these youngsters will did not receive any information with regards to physical activity. Conversely, the non-blinded subjects were informed that the device was an accelerometer that assessed physical activity levels and patterns. Participants will be instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall duration and the duration relative to the quality of the physical activity patterns (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group during the 4-day monitoring, then compared between the two groups using the Student's t test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• 10-18 years old adolescent

• normal clinical examination,

• normal nutritional status at baseline defined by a weight / height ratio between - 2 and + 2 DS DS

Exclusion Criteria:

• abnormal ECG

• known chronic disease

• acute infection dating back at least a week.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Physical Activity

Intervention

Device:
• GT3X Actigraph accelerometer.

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandre - CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity by GT3X Actigraph accelerometer.	The physical activity measured in counts/day using an GT3X Actigraph accelerometer.; Participants were instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring.	during 4 days	No