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Идёт набор NCT06551870

Xbox Kinect Sports Versus Nintendo Switch Sports

Без фазы С лечением Healthy People Programs

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Physical activity.
Кому может быть актуально
Состояния в реестре: Healthy People Programs. Базовые параметры: 60 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чили
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Xbox Kinect Sports Versus Nintendo Switch Sports and Their Effects on Body Composition and Physical Performance in Older Female: A Randomized Controlled Trial

Обзор

The aim of this study will be to compare the effects of Xbox Kinect Sports (XKS) with respect to Nintendo Switch Sports (NSS) and the inactive control group (CG) on body composition (percent body fat and fat-free mass) and physical performance (hand grip strength, HGS; 30 seconds standing in a chair, timed get up and walk, TUG; sit and reach and 2-minute step test) in physically inactive older women. This study will be randomized controlled trial with three parallel groups: XKS (n= 13), NSS (n= 14) and CG (n= 16).

Подробное описание

A sealed envelope lottery will be conducted for randomization with a three-arm randomized controlled trial design (XKS, NSS, and CG) with a simple double-blind design (raters and participants). The randomizer's website (https://www.randomizer.org) will be used to carry out the randomization process. The CONSORT guidelines method will be used (Turner et al., 2012). Fifty-two older women initially participated in the intervention. Following previous studies (Hernandez Martínez et al., 2022; Queiroz et al., 2017), the minimum difference needed for significant clinical relevance was a mean difference of 0.60 seconds in TUG, with a standard deviation of 0.20 seconds. An alpha level of 0.05, a power of 85% and an anticipated loss of 20% were considered. The Gpower program (version 3.1.9.6, Franz Faul, Universiät Kiel, Kiel, Germany) was used to calculate the statistical power. The inclusion criteria are as follows: (i) older women, between 60 and 65 years of age; (ii) who did not present cognitive impairment with a score on the Mini-Mental State Examination ≤21 points (Ministerio de Salud, 2013); (iii) who did not present visual difficulty and/or vestibular impairment that would make it difficult to play the games in front of the screen; (iv) who were independent, defined by having at least a score of 43 points on the Chilean Ministry of Health's Preventive Medicine Examination for Older Adults (Ministerio de Salud, 2013); (v) who could meet the attendance requirement of at least 85% of the sessions scheduled for the intervention; (vi) physically inactive who did not meet the international recommendations for moderate (\<150 to 300 minutes) or vigorous (\<75 to 150 minutes) physical activity (Bull et al., 2020); and (vii) physical condition compatible with the practice of physical activity. As for exclusion criteria, the following were taken into account (i) being afflicted with a disability; (ii) suffering from a musculoskeletal injury or receiving physical rehabilitation therapy, which prevents them from performing their usual physical activity; and (iii) being temporarily or permanently unable to perform physical activity.

By approving the use of the data for scientific purposes by signing an informed consent form, all participants acknowledged the inclusion criteria for the use and treatment of the data. The protocol was created by the Declaration of Helsinki and approved by the scientific ethics committee of the Universidad Católica del Maule, Chile (Approval number: N°29-2022).

Вмешательства

  • Другое Physical activity
    The complexity of the games will increase as the levels of the sports games advance, which leads to faster movements with greater demands to progress in the sequence of the games, which allows reaching increases in intensity.

Первичные конечные точки

  • Change from Fat-free mass at 12 weeks [Срок оценки: 2 weeks]
  • Change from Body fat percentage at 12 weeks [Срок оценки: 2 weeks]
  • Change from Maximal isometric handgrip strength at 12 weeks [Срок оценки: 2 weeks]
  • Change from 30-second chair stand test at 12 weeks [Срок оценки: 2 weeks]
  • Change from Timed up-and-go test at 12 weeks [Срок оценки: 2 weeks]
  • Change from Sit-and-reach test at 12 weeks [Срок оценки: 2 weeks]
  • Change from 2-minute step test at 12 weeks [Срок оценки: 2 weeks]
Вторичные конечные точки (3)
  • Age [Срок оценки: 1 week]
  • Academic level [Срок оценки: 1 week]
  • Civil status [Срок оценки: 1 week]

Критерии участия

Критерии включения

  • Older female aged between 60 and 75 years old.
  • Presenting the ability to understand and execute direct commands in a contextualized manner.
  • Independent, that is, have a score equal to or greater than 43 points in the Preventive Medicine Exam for the Older People (in Spanish, EMPAM) of the Ministry of Health (Ministerio de Salud, 2013).
  • Did not present any visual difficulty and/or any vestibular alteration that would hinder the performance of the games in front of the screen-
  • Complying with at least 85% attendance at the sessions scheduled for interventions.

Критерии исключения

  • Having any disabling disease.
  • Those female who have musculoskeletal injuries or who are undergoing physical rehabilitation treatment that prevents their normal physical performance.
  • Those who have permanent or temporary contraindications to perform physical activity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Чили · 1 центр
  • Community center — Osorno

Публикации

  • Bruun IH, Mogensen CB, Norgaard B, Schiottz-Christensen B, Maribo T. Validity and Responsiveness to Change of the 30-Second Chair-Stand Test in Older Adults Admitted to an Emergency Department. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):265-274. doi: 10.1519/JPT.0000000000000166. PMID 29227412
  • Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical PMID 33239350
  • Christopher A, Kraft E, Olenick H, Kiesling R, Doty A. The reliability and validity of the Timed Up and Go as a clinical tool in individuals with and without disabilities across a lifespan: a systematic review. Disabil Rehabil. 2021 Jun;43(13):1799-1813. doi: 10.1080/09638288.2019.1682066. Epub 2019 Oct 26. PMID 31656104
  • Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155. PMID 19565683
  • Hernandez Martínez, J., Ramirez Campillo, R., Álvarez, C., Valdés Badilla, P. A., Moran, J., & Izquierdo, M. (2022). Effects of active exergames training on physical functional performance in older females. Cultura_Ciencia_Deporte [CCD], 51(17).
  • Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028. PMID 10380242
  • Lemmink KA, Kemper HC, de Greef MH, Rispens P, Stevens M. The validity of the sit-and-reach test and the modified sit-and-reach test in middle-aged to older men and women. Res Q Exerc Sport. 2003 Sep;74(3):331-6. doi: 10.1080/02701367.2003.10609099. No abstract available. PMID 14510299
  • Li J, Li L, Huo P, Ma C, Wang L, Theng YL. Wii or Kinect? A Pilot Study of the Exergame Effects on Older Adults' Physical Fitness and Psychological Perception. Int J Environ Res Public Health. 2021 Dec 8;18(24):12939. doi: 10.3390/ijerph182412939. PMID 34948547

Идентификаторы

NCT: NCT06551870 · 29/2022

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗