HealthyNCT01989104
Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)
An observational study of Healthy, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Apr 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Community sample
Who may be able to join
- 6 to 20 years of age at the time of study enrollment
- Not limited in the ability to walk
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the 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)
- 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.
- Conditions
- Healthy
- Keywords
- Indirect calorimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | 6-12 years of age | |
| Adolescents | 13-17 years of age | |
| Young adults | 18-20 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cadence - Steps Per Minute
Cadence steps per minute represents an overlooked opportunity to describe the intensity of ambulatory activity.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Catrine Tudor-Locke, PhD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989104
- Sponsor's protocol ID
- PBRC 13019
- Other IDs
- 1R21HD073807-01A1
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2013
- Last updated
- 1 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34271922Tudor-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.
PubMed 29482554
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)
- ClinicalTrials.gov ID
- NCT01989104
- Acronym / sponsor ID
- PBRC 13019
- Conditions
- Healthy
- Keywords
- Indirect calorimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 1 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children | – | –6-12 years of age |
| Adolescents | – | –13-17 years of age |
| Young adults | – | –18-20 years of age |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- 6 to 20 years of age at the time of study enrollment
- Not limited in the ability to walk
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cadence - Steps Per Minute
Time frame: 1 day
Cadence steps per minute represents an overlooked opportunity to describe the intensity of ambulatory activity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34271922Gould 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.
- Derived from this study: PubMed 29482554Tudor-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.
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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.
Catrine Tudor-Locke, PhD principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Pennington Biomedical Research Center at 1 site in United States.
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 2 inclusion and 7 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cadence - Steps Per Minute (time frame: 1 day). 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 NCT01989104, which also lists 2 linked publications.
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 1 Dec 2022.