NCT05770817

Brief Summary

The SKyRoCKeT Study (Surface-Knit and Reformulate CADENCE-Kids for Translation) will recruit a sex- and age-balanced sample of 360 young people 6-20 years of age to develop an integrative, physiologically-coherent age-cadence-log(metabolic equivalent, MET) surface-based model, reformulate the prior R21 CADENCE-Kids study (1; NCT01989104) by providing individualized, more precise, age-specific and coherent cadence-intensity thresholds, investigate additional differences by anthropometric factors, and translate cadence-intensity thresholds to over-ground walking. The SKyRoCKeT Study is an innovative critical step to provide a coherent, interpretable, objectively monitored step-based intensity metric to inform (inter)national physical activity (PA) guidelines by transforming currently vague guidelines of PA intensity into quantifiable PA recommendations that can be of widespread use, which clinicians, young people, parents, and researchers can integrate into preventive care management and action plans for personalized care. The SKyRoCKeT Study will allow for a user-friendly, interpretable metric to more accurately inform public health/behavioral interventions, assessments, analyses, school-based health and physical education curricula and programs, and public health messages for young people and their caregivers.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Apr 2023Mar 2027

First Submitted

Initial submission to the registry

March 1, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

April 5, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

March 1, 2023

Last Update Submit

April 28, 2026

Conditions

Keywords

cadencestepsphysical activityphysical activity intensitymetabolic equivalents (METs)cardiorespiratory fitnessindirect calorimetryyouth

Outcome Measures

Primary Outcomes (1)

  • Cadence (steps per minute)

    Cadence (steps per minute) represents an overlooked opportunity to describe the intensity of ambulatory activity.

    Over the course of the study period (up to 3 months) across 3 visits plus an at-home free-living protocol per participant (see Protocol/Procedures)

Study Arms (1)

6-20-year-old youth

6-20-year-old youth

Other: N/A: SKyRoCKeT is an observational study

Interventions

None; this is an observational study

6-20-year-old youth

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community Sample

You may qualify if:

  • Between 6 - 20 years of age on the day of signing the informed consent/assent.
  • Able to walk without the need of assistance

You may not qualify if:

  • Need for assistance with walking including the use of a wheelchair
  • Mental illness requiring hospitalization within the past 5 years
  • Medical condition or medications that affect(s) changes in heart rate with exercise
  • Current pregnancy
  • Pacemaker or other implanted medical device including metal joint replacements
  • History of cardiovascular disease, stroke, transient ischemic attacks (TIA, mini-stroke), chest pain, unusual shortness of breath during physical activity/exercise, swelling in legs/ankles, or excessive leg pain with exercise.
  • History of musculoskeletal problems that cause pain during physical activity which interferes with the ability to walk
  • Exercise-induced asthma requiring medications prior to low intensity activities like walking
  • Unavailable for the entire duration of the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Charlotte

Charlotte, North Carolina, 28223, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29482554BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Catrine Tudor-Locke, PhD

    University of North Carolina at Charlotte

    PRINCIPAL INVESTIGATOR
  • Laura H Gunn, PhD

    University of North Carolina at Charlotte

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catrine Tudor-Locke, PhD

CONTACT

Laura H Gunn, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 15, 2023

Study Start

April 5, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The de-identified dataset will be published along with open-access manuscripts as a supplemental file and available to anyone accessing the article. Requests for de-identified individual-level data (including descriptors) collected in SKyRoCKeT and used in publications will be considered and made available to qualified researchers, in accordance with the NIH Data Sharing Policy and Final NIH Statement on Sharing Research Data. Data sharing agreements will be necessary for access. The SKyRoCKeT database will be maintained and access ensured by SKyRoCKeT team members at the University of North Carolina at Charlotte.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will become available upon manuscript publication of the full study cohort.
Access Criteria
Requests for de-identified individual-level data (including descriptors) collected in SKyRoCKeT and used in publications will be considered and made available to qualified researchers within 2 years of publication of the associated paper. Data sharing agreements will be necessary for access.

Locations