跳至主要内容
临床试验/NCT06551870
NCT06551870招募中不适用

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

Universidad Católica del Maule2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
2
主要终点
Change from Fat-free mass at 12 weeks

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change from Fat-free mass at 12 weeks

时间窗: 2 weeks

This variable is obtained by body composition (bioimpedance), using eight-electrode tetrapolar bioimpedance (InBody 570®, Body Composition Analyzers, South Korea). For each measurement, the guidelines of the International Society for Advances in Kinanthropometry will be followed (Marfell-Jones et al., 2012).

Change from 2-minute step test at 12 weeks

时间窗: 2 weeks

Cardiorespiratory fitness was measured using the 2-minute step test (Rikli \& Jones, 2013). Participants were asked to stand up straight and the average distance between the kneecap and the pelvic bones was marked on a wall with colored tape. Participants performed steps so that their knees were raised above the marked point and the number of repetitions in 2 minutes was recorded (Rikli \& Jones, 2013).

Change from 30-second chair stand test at 12 weeks

时间窗: 2 weeks

The 30-second chair stand test (Bruun et al., 2019), which measures the number of repetitions performed standing and sitting in a chair with arms resting on the chest for 30 seconds, will be used to assess lower limb muscle strength and the ability to perform activities of daily living (Jones et al., 1999). The best of the three efforts will be taken into account for the analysis after three attempts, with a recovery of 120 seconds between them.

Change from Maximal isometric handgrip strength at 12 weeks

时间窗: 2 weeks

Previous recommendations indicate that maximal isometric handgrip strength (Lupton-Smith et al., 2022), was employed. The best position for testing was found to be sedentary, with the wrist and forearm in a neutral position, the elbow flexed at a 90-degree angle to the side of the body, the spine aligned, and the shoulder in a neutral position. A portable dynamometer (Jamar®, PLUS+, Sammons Preston, Patterson Medical, Warrenville, IL, USA) was used for testing. The dynamometer was placed in the first position, which promotes contact between the first phalanx of the thumb and index finger, to allow a firm grip on the device while preserving proper closure of the metacarpal, palatine, and interphalangeal joints based on hand size. Each participant performed three attempts with each hand after a 120-second rest.

Change from Timed up-and-go test at 12 weeks

时间窗: 2 weeks

The tiemd up-and- go test will be performed according to previous recommendations (Christopher et al., 2021). The individual will be asked to get out of a chair with arm rests, walk down a 3-meter hallway, turn around, and return to the chair. The timed up-and-go is a measure of functional mobility and dynamic balance (Podsiadlo \& Richardson, 1991). They are asked to perform three trials and quickly record the best one. Using single-beam photocells (Brower Timing System, Draper, UT, USA), two evaluators will record the time; a statistical analysis of the three best trials will be performed.

Change from Body fat percentage at 12 weeks

时间窗: 2 weeks

This variable will be obtained by body composition (bioimpedance), using eight-electrode tetrapolar bioimpedance (InBody 570®, Body Composition Analyzers, South Korea). For each measurement, the guidelines of the International Society for Advances in Kinanthropometry will be followed (Marfell-Jones et al., 2012).

Change from Sit-and-reach test at 12 weeks

时间窗: 2 weeks

Using the sit-and-reach test, flexibility was assessed (Rikli \& Jones, 2013). Subjects sat forward in a chair with a fixed back, one leg bent on the floor and the other left leg straight. Either the left or right leg could be used for comfortable running; however, the post-test measured the same leg as the pre-test. After correcting one position once again, the other bent leg case was assessed for flexibility by running two trials using the highest number to determine the outcome (Lemmink et al., 2003).

次要结局

  • Civil status(1 week)
  • Age(1 week)
  • Academic level(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Valdés-Badilla

Researcher

Universidad Católica del Maule

研究点 (2)

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