Clinical trial NCT01989104: Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)
Official title: Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Indirect calorimetry
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-11-20
Enrollment: 123
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.

Eligibility criteria: Inclusion Criteria:

* 6 to 20 years of age at the time of study enrollment
* Not limited in the ability to walk

Exclusion Criteria:

* Hospitalization for mental illness within the past 5 years.
* Any condition/medication that may affect heart rate response to exercise testing.
* Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks, chest pain, unusual dyspnea during physical activity/exercise, severe ankle edema, or intermittent claudication.
* Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.
* Participant has a pacemaker or other implanted medical device (including metal joint replacements).
* Participant is pregnant.
* Participant is unable to complete all testing (1 or two sessions, as preferred) within a maximal two week period.

Primary outcomes:
measure: Cadence - Steps Per Minute
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: University of Massachusetts, Amherst
name: Catrine Tudor-Locke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gould ZR, Mora-Gonzalez J, Aguiar EJ, Schuna JM Jr, Barreira TV, Moore CC, Staudenmayer J, Tudor-Locke C. A catalog of validity indices for step counting wearable technologies during treadmill walking: the CADENCE-Kids study. Int J Behav Nutr Phys Act. 2021 Jul 16;18(1):97. doi: 10.1186/s12966-021-01167-y.
citation: Tudor-Locke C, Schuna JM Jr, Han H, Aguiar EJ, Larrivee S, Hsia DS, Ducharme SW, Barreira TV, Johnson WD. Cadence (steps/min) and intensity during ambulation in 6-20 year olds: the CADENCE-kids study. Int J Behav Nutr Phys Act. 2018 Feb 26;15(1):20. doi: 10.1186/s12966-018-0651-y.