Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551870
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Xbox Kinect Sports Versus Nintendo Switch Sports
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XbNin
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 randomizers website httpswwwrandomizerorg 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 060 seconds in TUG with a standard deviation of 020 seconds An alpha level of 005 a power of 85 and an anticipated loss of 20 were considered The Gpower program version 3196 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 andor 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 Healths 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 N29-2022
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 N29-2022
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None