Clinical trial NCT06551870: Xbox Kinect Sports Versus Nintendo Switch Sports
Official title: Xbox Kinect Sports Versus Nintendo Switch Sports and Their Effects on Body Composition and Physical Performance in Older Female: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy People Programs
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 45
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Fat-free mass at 12 weeks
timeFrame: 2 weeks
measure: Change from Body fat percentage at 12 weeks
timeFrame: 2 weeks
measure: Change from Maximal isometric handgrip strength at 12 weeks
timeFrame: 2 weeks
measure: Change from 30-second chair stand test at 12 weeks
timeFrame: 2 weeks
measure: Change from Timed up-and-go test at 12 weeks
timeFrame: 2 weeks
measure: Change from Sit-and-reach test at 12 weeks
timeFrame: 2 weeks
measure: Change from 2-minute step test at 12 weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Age
timeFrame: 1 week
measure: Academic level
timeFrame: 1 week
measure: Civil status
timeFrame: 1 week
Other outcomes:
Locations:
city: Osorno
country: Chile
facility: Community center
state: Región De Los Lagos
Study officials:
affiliation: Universidad Católica del Maule
name: Pablo Valdés-Badilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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