NCT06551870

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 6, 2024

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Change from Fat-free mass at 12 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).

    2 weeks

  • Change from Body fat percentage at 12 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).

    2 weeks

  • Change from Maximal isometric handgrip strength at 12 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.

    2 weeks

  • Change from 30-second chair stand test at 12 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.

    2 weeks

  • Change from Timed up-and-go test at 12 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.

    2 weeks

  • Change from Sit-and-reach test at 12 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).

    2 weeks

  • Change from 2-minute step test at 12 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).

    2 weeks

Secondary Outcomes (3)

  • Age

    1 week

  • Academic level

    1 week

  • Civil status

    1 week

Study Arms (3)

Experimental group 1 (Xbox Kinect Sports)

EXPERIMENTAL

The programs were then designed for a duration of 12 weeks (36 sessions), with a 10-minute warm-up consisting of low-intensity aerobic activities and joint mobility, a 40-minute main part and a 10-minute cool-down with static flexibility exercises. The main part of the training sessions included active exergames of volleyball, bowling, boxing, and table tennis, each lasting 8 minutes, with 2 minutes of rest between games. In these active exergames, playing the games will require standing in front of a sensor on a camera under the TV screen in a 3.5-meter-wide range of motion (Li et al., 2021; Marotta et al., 2022).

Other: Physical activity

Experimental group 2 (Nintendo Switch Sports)

EXPERIMENTAL

The programs were then designed for a duration of 12 weeks (36 sessions), with a 10-minute warm-up consisting of low-intensity aerobic activities and joint mobility, a 40-minute main part and a 10-minute cool-down with static flexibility exercises. In Nintendo Switch Sports in order to run the games of these active exergames you will have to have a controller in your hand that has no cable because it connects via Bluetooth to the console, as in Xbox Kinect Sports you have to play in front of the TV screen (Ramolete et al., 2020). In Nintendo Switch Sports, there will be active exergames of volleyball, bowling, fencing and tennis in the main part, each of 8 min duration, with 2 minutes of rest between games.

Other: Physical activity

Control group

NO INTERVENTION

The control group, the individuals will participate in the assessments (initial and final) and only played board games twice a week for 60 minutes.

Interventions

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.

Also known as: Physical fitness
Experimental group 1 (Xbox Kinect Sports)Experimental group 2 (Nintendo Switch Sports)

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community center

Osorno, Los Lagos Region, 5290000, Chile

RECRUITING

Related Publications (19)

  • 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.

  • 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 activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

  • 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.

  • Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.

  • 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).

    RESULT
  • 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.

  • 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.

  • 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.

  • Lupton-Smith A, Fourie K, Mazinyo A, Mokone M, Nxaba S, Morrow B. Measurement of hand grip strength: A cross-sectional study of two dynamometry devices. S Afr J Physiother. 2022 Sep 26;78(1):1768. doi: 10.4102/sajp.v78i1.1768. eCollection 2022.

  • Marfell-Jones, M., Olds, T., & De Ridder, J. (2012). International Standards for Anthropometric Assessment (Vol. 137).

    RESULT
  • Marotta N, Demeco A, Indino A, de Scorpio G, Moggio L, Ammendolia A. Nintendo WiiTM versus Xbox KinectTM for functional locomotion in people with Parkinson's disease: a systematic review and network meta-analysis. Disabil Rehabil. 2022 Feb;44(3):331-336. doi: 10.1080/09638288.2020.1768301. Epub 2020 Jun 1.

  • Ministerio de Salud. (2013). Manual de Aplicación del Examen de Medicina Preventiva del Adulto Mayor. . https://www.minsal.cl/portal/url/item/ab1f81f43ef0c2a6e04001011e011907.pdf

    RESULT
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  • Queiroz, B. M. d., Borgatto, A. F., Barbosa, A. R., & Guimarães, A. V. (2017). Exergame vs. Aerobic Exercise and Functional Fitness of Older Adults: A Randomized Controlled Trial. Journal of physical education and sport, 17, 740.

    RESULT
  • Ramolete, G., Almirante, J., Mondragon, J., Ting, C., Cohen, M., & Custodio, B. (2020). Physical Design Assessment of the Nintendo Switch Controller Configurations. In (pp. 198-205). https://doi.org/10.1007/978-3-030-51038-1_29

    RESULT
  • Richardson, J. T. E. (2011). Eta squared and partial eta squared as measures of effect size in educational research. Educational Research Review, 6(2), 135-147. https://doi.org/https://doi.org/10.1016/j.edurev.2010.12.001

    RESULT
  • Rikli, R. E., & Jones, C. J. (2013). Senior fitness test manual. Human kinetics.

    RESULT
  • Rytterstrom P, Stromberg A, Jaarsma T, Klompstra L. Exergaming to Increase Physical Activity in Older Adults: Feasibility and Practical Implications. Curr Heart Fail Rep. 2024 Aug;21(4):439-459. doi: 10.1007/s11897-024-00675-9. Epub 2024 Jul 18.

  • Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, Schulz KF, Plint AC, Moher D. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012 Nov 14;11(11):MR000030. doi: 10.1002/14651858.MR000030.pub2.

MeSH Terms

Interventions

ExercisePhysical Fitness

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealthPopulation Characteristics

Study Officials

  • Pablo Valdés-Badilla, PhD

    Universidad Católica del Maule

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Valdés-Badilla, PhD

CONTACT

Ranjeeva Ranjan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 13, 2024

Study Start

April 14, 2024

Primary Completion

December 14, 2024

Study Completion

December 14, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Participant data will not be shared. We will only disseminate the results of the study through scientific papers and presentations at scientific congresses.

Locations