Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-30 @ 11:26 PM
Study NCT ID:
NCT01989104
Status:
COMPLETED
Last Update Posted:
2022-12-01
First Post:
2013-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)
Sponsor:
Pennington Biomedical Research Center
Organization:
Study Overview
Official Title:
Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to measure and link cadence (number of steps taken in a minute) to intensity of physical activity (e.g., low-intensity, moderate-intensity, vigorous-intensity) in children and adolescents (6-20 years-old), and to identify the cadence values corresponding to children's and adolescent's behavior during simulated free-living activities.
Detailed Description:
Procedure - 1 visit - (approximately 3 hours in total)
Day of Testing: Participant must be FASTED - No food for 4 hours before visit. All of the study procedures involving the participant will be completed in a single testing session (one-day - approximately 3 hours) at the Pennington Biomedical Research Center. If preferred, two visits on separate days can be scheduled to complete the protocol.
* Screening questions (approximately 3-5 minutes)
o Participants (or their legal guardian) will be asked to answer several screening questions to determine their eligibility for participating in CADENCE-KIDS.
* Height and weight measures data collection (approximately 10 minutes)
* Height will be measured.
* Body weight and body fat percentage will be measured using a specialized scale.
* Waist circumference will then be measured using a measuring tape.
* Instrument attachment, treadmill walking, free-living activities (approximately 140 minutes)
* Participants will be fitted with 10 devices (Digi-Walker Pedometer, NL-1000 Pedometer, StepWatch Activity Monitor, SenseWear Armband, GT3X+ accelerometer, GENEActiv Accelerometer, Actical Accelerometer, ActivPal Accelerometer, Polar Heart Rate Monitor, K4b2 Portable Metabolic Unit) to measure/monitor physical activity throughout the testing session.
* Participants will then complete several low intensity free-living activities while their physical activity and oxygen uptake are concurrently assessed. Specifically, participants will rest in a chair, watch a portion of a child-friendly movie while seated in a chair, and color in a coloring book while seated in a chair. Each activity will last for 5 minutes and a 2 minute rest will occur between each activity.
* Participants will then complete a series of walking bouts on a treadmill while their physical activity and oxygen uptake are concurrently assessed. The walking bouts start at 0.5 miles per hour and end at 5 miles per hour (0.5 miles per hour increments). Treadmill testing stops when the participant finishes the bout where they naturally select to jog/run, or following the completion of the last bout at 5.0 miles per hour, whichever occurs first. A 2 minute rest will occur between each treadmill bout.
* Participants will then complete three additional free-living activities where physical activity and oxygen uptake continue to be concurrently measured. Specifically, participants will step up and down on an aerobic step at 88 beats per minute, dribble a basketball, and perform jumping jacks at 126 beats per minute (63 jumping jacks per minute). Each activity will last for 5 minutes and a 2 minute rest will occur between each activity.
Day of Testing: Participant must be FASTED - No food for 4 hours before visit. All of the study procedures involving the participant will be completed in a single testing session (one-day - approximately 3 hours) at the Pennington Biomedical Research Center. If preferred, two visits on separate days can be scheduled to complete the protocol.
* Screening questions (approximately 3-5 minutes)
o Participants (or their legal guardian) will be asked to answer several screening questions to determine their eligibility for participating in CADENCE-KIDS.
* Height and weight measures data collection (approximately 10 minutes)
* Height will be measured.
* Body weight and body fat percentage will be measured using a specialized scale.
* Waist circumference will then be measured using a measuring tape.
* Instrument attachment, treadmill walking, free-living activities (approximately 140 minutes)
* Participants will be fitted with 10 devices (Digi-Walker Pedometer, NL-1000 Pedometer, StepWatch Activity Monitor, SenseWear Armband, GT3X+ accelerometer, GENEActiv Accelerometer, Actical Accelerometer, ActivPal Accelerometer, Polar Heart Rate Monitor, K4b2 Portable Metabolic Unit) to measure/monitor physical activity throughout the testing session.
* Participants will then complete several low intensity free-living activities while their physical activity and oxygen uptake are concurrently assessed. Specifically, participants will rest in a chair, watch a portion of a child-friendly movie while seated in a chair, and color in a coloring book while seated in a chair. Each activity will last for 5 minutes and a 2 minute rest will occur between each activity.
* Participants will then complete a series of walking bouts on a treadmill while their physical activity and oxygen uptake are concurrently assessed. The walking bouts start at 0.5 miles per hour and end at 5 miles per hour (0.5 miles per hour increments). Treadmill testing stops when the participant finishes the bout where they naturally select to jog/run, or following the completion of the last bout at 5.0 miles per hour, whichever occurs first. A 2 minute rest will occur between each treadmill bout.
* Participants will then complete three additional free-living activities where physical activity and oxygen uptake continue to be concurrently measured. Specifically, participants will step up and down on an aerobic step at 88 beats per minute, dribble a basketball, and perform jumping jacks at 126 beats per minute (63 jumping jacks per minute). Each activity will last for 5 minutes and a 2 minute rest will occur between each activity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21HD073807-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |