- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01989104
Cadence and Intensity in Children and Adolescents (CADENCE-KIDS)
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70808
- Pennington Biomedical Research Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Inny
- Perspektywy czasowe: Przekrojowe
Kohorty i interwencje
Grupa / Kohorta |
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Children
6-12 years of age
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Adolescents
13-17 years of age
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Young adults
18-20 years of age
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Cadence - Steps Per Minute
Ramy czasowe: 1 day
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Cadence steps per minute represents an overlooked opportunity to describe the intensity of ambulatory activity.
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1 day
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Catrine Tudor-Locke, PhD, University of Massachusetts, Amherst
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- PBRC 13019
- 1R21HD073807-01A1 (Grant/umowa NIH USA)
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