Healthy People ProgramsXb&NinNCT06551870
Xbox Kinect Sports Versus Nintendo Switch Sports
A study testing Physical activity in people with Healthy People Programs, run by Universidad Católica del Maule at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy People Programs
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChile
- Study dates
- 14 Apr 2024to 14 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Community center
Osorno, Los Lagos Region, 5290000
Pablo Valdés-Badilla, PhD, +56971258824, valdesbadilla@gmail.com
Jordan Hernandez-Martínez, MsC, +56940514789, jordan.hernandez@ulagos.cl
About this study
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
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).
Read the 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).
- Conditions
- Healthy People Programs
- Being tested
- Physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Also called Physical fitness
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 2 weeks
Secondary outcomes (3)
Age
In years, through an interview and identity card.
Measured: 1 week
Academic level
Primary, secondary, bachelor, master, PhD. Consulting their curriculum background
Measured: 1 week
Civil status
Married, separated, widow, single, others. Through an interview
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start14 Apr 2024
- Primary completion14 Dec 2024 (estimated)
- Study completion14 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Healthy People ProgramsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Maule
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Valdés-Badilla, Universidad Católica del Maule
- Investigators
- Pablo Valdés-Badilla, PhD, Principal investigator, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551870
- Sponsor's protocol ID
- 29/2022
- Acronym
- Xb&Nin
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared. We will only disseminate the results of the study through scientific papers and presentations at scientific congresses.
Publications
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.
PubMed 29227412Bull 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.
PubMed 33239350Christopher 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.
PubMed 31656104Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
PubMed 19565683Hernandez 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.
PubMed 10380242Lemmink 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.
PubMed 14510299Li 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.
PubMed 34948547Lupton-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.
PubMed 36262213Marfell-Jones, M., Olds, T., & De Ridder, J. (2012). International Standards for Anthropometric Assessment (Vol. 137).
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.
PubMed 32478581Ministerio de Salud. (2013). Manual de Aplicación del Examen de Medicina Preventiva del Adulto Mayor. . https://www.minsal.cl/portal/url/item/ab1f81f43ef0c2a6e04001011e011907.pdf
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.
PubMed 1991946Queiroz, 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06551870
- Acronym / sponsor ID
- Xb&Nin / 29/2022
- Conditions
- Healthy People Programs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad Católica del MauleUniversity, hospital or other
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 14 Dec 2024 (estimated)
- Study completion
- 14 Dec 2024 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 (Xbox Kinect Sports) | Experimental | Other: Physical activityThe 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). |
| Experimental group 2 (Nintendo Switch Sports) | Experimental | Other: Physical activityThe 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. |
| 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: Physical fitnessThe 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. | Other | Experimental group 1 (Xbox Kinect Sports), Experimental group 2 (Nintendo Switch Sports) |
Primary outcome
Change from Fat-free mass at 12 weeks
Time frame: 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 Body fat percentage at 12 weeks
Time frame: 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 Maximal isometric handgrip strength at 12 weeks
Time frame: 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 30-second chair stand test at 12 weeks
Time frame: 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 Timed up-and-go test at 12 weeks
Time frame: 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 Sit-and-reach test at 12 weeks
Time frame: 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).
Change from 2-minute step test at 12 weeks
Time frame: 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).
3 secondary outcomes
Age
Time frame: 1 week
Academic level
Time frame: 1 week
Civil status
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Results publication: PubMed 29227412Bruun 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.
- Results publication: PubMed 33239350Bull 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.
- Results publication: PubMed 31656104Christopher 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.
- Results publication: PubMed 19565683Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
- Results publicationHernandez 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).
- Results publication: PubMed 10380242Jones 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.
- Results publication: PubMed 14510299Lemmink 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.
- Results publication: PubMed 34948547Li 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.
- Results publication: PubMed 36262213Lupton-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.
- Results publicationMarfell-Jones, M., Olds, T., & De Ridder, J. (2012). International Standards for Anthropometric Assessment (Vol. 137).
- Results publication: PubMed 32478581Marotta 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.
- Results publicationMinisterio de Salud. (2013). Manual de Aplicación del Examen de Medicina Preventiva del Adulto Mayor. . https://www.minsal.cl/portal/url/item/ab1f81f43ef0c2a6e04001011e011907.pdf
- Individual participant dataSharing planned: No. Participant data will not be shared. We will only disseminate the results of the study through scientific papers and presentations at scientific congresses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Valdés-Badilla, PhD principal investigator
Universidad Católica del Maule
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Healthy People Programs, run by Universidad Católica del Maule at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo Valdés-Badilla, PhD (+56971258824, valdesbadilla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Fat-free mass at 12 weeks (time frame: 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06551870, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.