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Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01989104
First Posted: November 20, 2013
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
William D. Johnson, Ph.D., Pennington Biomedical Research Center
  Purpose
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.

Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)

Further study details as provided by William D. Johnson, Ph.D., Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Cadence [ Time Frame: 1 point ]
    Steps/min determined by observation and various body worn devices

  • Metabolic cost [ Time Frame: 1 point ]
    Indirect calorimetry-assessed metabolic costs of specific activities


Estimated Enrollment: 150
Study Start Date: December 2013
Study Completion Date: April 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children
6-12 years of age
Adolescents
13-17 years of age
Young adults
18-20 years of age

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989104


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Catrine Tudor-Locke, PhD Penningtion Biomedical Research Center
  More Information

Responsible Party: William D. Johnson, Ph.D., Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01989104     History of Changes
Other Study ID Numbers: PBRC 13019
1R21HD073807-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 14, 2013
First Posted: November 20, 2013
Last Update Posted: April 24, 2017
Last Verified: April 2017

Keywords provided by William D. Johnson, Ph.D., Pennington Biomedical Research Center:
Indirect calorimetry