跳至主要内容
临床试验/NCT05770817
NCT05770817招募中不适用

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

University of North Carolina, Charlotte1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2023年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
360
试验地点
1
主要终点
Cadence (steps per minute)

研究概览

简要总结

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.

详细描述

Specific Aims: The SKyRoCKeT Study will:

  1. Expand CADENCE-Kids (1; NCT01989104) to innovatively surface-'knit' the age dimension through a continuous, unbiased-by-age, and physiologically-coherent age-cadence-log(MET) flexible surface approach without artificially-generated jumps between age ranges and with enhanced precision of cadence-intensity threshold estimates. This single surface will coherently transition between ages, borrow inter-age information, and be data-driven.
  2. Reformulate CADENCE-Kids (1; NCT01989104) by providing age-specific cadence-intensity thresholds, calculated with enhanced precision for moderate and vigorous PA. Data will be objectively collected using a similar treadmill protocol to the R21-funded pilot study, with incrementally faster paces. Age-specific results will be compared to the pilot's age-range thresholds. A full running bout will now also be included. The investigators will concurrently collect cadence with direct observation and with multiple contemporary wearable technologies. Collecting cardiorespiratory fitness (CRF) and habitual PA data, the investigators will develop additional, innovative algorithms to predict relative intensity defined by lab-based indicators of oxygen uptake (%VO2peak, %VO2R), heart rate (%HRR, %HRmax), and rate of perceived of exertion (RPE) to facilitate computation of individually calibrated thresholds applicable to the free-living or habitual PA living condition. Investigators will assess differences in surfaces and cadence-intensity thresholds by sex and body mass index standard deviation scores (BMI SDS). Height- and/or leg-length-specific (hyper)surfaces will be explored as more precise alternatives to age.
  3. Propel science forward innovatively through translation to over-ground walking. The investigators hypothesize that treadmill-set cadence-intensity thresholds will reliably translate and be useful for eliciting predictable metabolic costs during over-ground walking emblematic of free-living ambulatory behaviors.

Protocol/Procedures: 3 visits to the lab and 1 at home, free-living protocol

Screening: Screening questions will be completed online by potential participants (or their parents, where appropriate) and will take approximately 5 minutes. Following the initial recruitment web screener, potential participants (or their parents, where appropriate) will complete a telephone screener to confirm their responses. Potential participants (or their parents, where appropriate) will then attend a virtual or in-person orientation during which the study design procedures will be described in detail. Eligible potential participants who remain interested in the study will be scheduled for their first lab visit (with their parent/guardian if between 6-17 years of age).

Days of Testing in the Lab: Upon signing informed consent(s), participants must be fasted (no food for 4 hours before visit). Study procedures involving participants will be completed at the University of North Carolina at Charlotte. Visits 1 and 2 will be conducted at the Health Risk Assessment Laboratory (HRAL), and visit 3 will be conducted on an indoor track. Visit 1 will occur first and will be immediately followed by a week of free-living physical activity monitoring at home. Visit 2 will be completed once free-living, at-home monitoring is complete, and will be followed by visit 3.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Cadence (steps per minute)

时间窗: 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)

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

次要结局

未报告次要终点

研究者

发起方
University of North Carolina, Charlotte
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura H Gunn

Principal Investigator

University of North Carolina, Charlotte

研究点 (1)

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