RECRUITING

The SKyRoCKeT Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Surface-Knit and Reformulate CADENCE-Kids for Translation: The SKyRoCKeT Study

Quick Facts

Study Start:2023-04-05
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05770817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 6 - 20 years of age on the day of signing the informed consent/assent.
  2. * Able to walk without the need of assistance
  1. * Need for assistance with walking including the use of a wheelchair
  2. * Mental illness requiring hospitalization within the past 5 years
  3. * Medical condition or medications that affect(s) changes in heart rate with exercise
  4. * Current pregnancy
  5. * Pacemaker or other implanted medical device including metal joint replacements
  6. * 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.
  7. * History of musculoskeletal problems that cause pain during physical activity which interferes with the ability to walk
  8. * Exercise-induced asthma requiring medications prior to low intensity activities like walking
  9. * Unavailable for the entire duration of the study period

Contacts and Locations

Study Contact

Catrine Tudor-Locke, PhD
CONTACT
704-687-7917
tudor-locke@uncc.edu
Laura H Gunn, PhD
CONTACT
704-687-7191
laura.gunn@uncc.edu

Principal Investigator

Catrine Tudor-Locke, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina at Charlotte
Laura H Gunn, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina at Charlotte

Study Locations (Sites)

University of North Carolina at Charlotte
Charlotte, North Carolina, 28223
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Charlotte

  • Catrine Tudor-Locke, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina at Charlotte
  • Laura H Gunn, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina at Charlotte

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-05
Study Completion Date2027-03

Study Record Updates

Study Start Date2023-04-05
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • cadence
  • steps
  • physical activity
  • physical activity intensity
  • metabolic equivalents (METs)
  • cardiorespiratory fitness
  • indirect calorimetry
  • youth

Additional Relevant MeSH Terms

  • Healthy