Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-08-26
2023-12-31
Brief Summary
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Sarcopenia is the progressive loss of skeletal muscle mass and decline of muscle function associated with aging. Frailty is defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems. Resistant, aerobic, and multi-component exercise could improve muscle strength and function in older adults. Some policies have been proposed and implemented to prevent and delay the frailty and disability among elders in long term care policy in Taiwan. However, due to shortage in healthcare provider, long-term exercise program is difficult to provide in long-term care facilities (LTCF) of countryside in Taiwan.
Method:
This will be a prospective randomized controlled trial comparing an exergame-based multicomponent training (Exergame-based REH) to standard of care in older users of LTCF in rural Kaohsiung city, Taiwan. Participants in the intervention group will receive Exergame-based REH for 12 weeks, while participants in the control group will receive standard care that routinely applied in the LTFC as usual. The Exergame-based REH contains progressive resistance training and functional movement of the four extremities but mainly upper limbs. The investigators will use the Ringfit Adventure to deliver the program. The Exergame-based REH will be performed twice per week, at least 48 hours apart from each training session, 50 minutes per time, for a total 12 weeks. Criteria of sarcopenia including (1) handgrip strength of dominant hand, (2) walking speed, and (3) appendicular skeletal muscle mass index of 4 extremities, and Study of osteoporotic fractures index, will be measured as primary outcomes. (1) Range of motions in dominant upper extremity, (2) maximal voluntary isometric contraction of biceps/triceps brachial muscles of dominant side, (3) box and block test, (4) Sonographic thickness of Biceps and Triceps Brachii muscles, (5) Kihon checklist-Taiwan version, (6) 36-Item Short Form Survey questionnaire, and (7) brain health test, will be measured as secondary outcomes before and after the programs.
Anticipated benefits:
The Exergame-based REH could enhance the motivation toward exercise of older adults. It could also increase muscle mass, strength, functional ability of dominant upper extremity, and health-related quality of life.
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Detailed Description
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Sarcopenia is the progressive loss of skeletal muscle mass and decline of muscle function associated with aging. The prevalence of sarcopenia among people older than 65 years old in Taiwan is over 20%. Sarcopenia is one of the most important causes of functional decline and loss of independence, even mortality in older adults. Frailty is theoretically defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems such that the ability to cope with everyday or acute stressors is comprised. Both sarcopenia and frailty are getting more and more concerns in Taiwan, which is now an aged-society. Resistant, aerobic, and multi-component exercise have been proved to improve muscle strength and function in older adults.
The principles of progressive resistance training and multi-component exercise programs include regular, mass-practiced, mild overwhelming engagement. These principles demand devoting time, workforce, and money to achieve. Staffing constraints and resources shortage have made it challenging to promote regular exercise programs in long-term care facilities. Exergames have been defined as any type of video game that requires the movement of the player's entire body, allowing real-time interaction. Exergames breaks down the barriers of repetitive and monotonous physical exercise since they contain attractive and multisensory game environments with an immersive environment in which the interaction takes place through global body movements. Moreover, the gamified approach and immersive scenarios motivate older people to acquire a greater commitment to the practice of physical and rehabilitative exercises. Therefore, by playing exergames, it reduces staff time for intervention, encourages patients to perform relatively high-energy movements, and increase participants' motivation.
Therefore, investigators in this study aim to evaluate the feasibility and clinical application of a novel exergame-based multicomponent training via Nintendo Switch® Ringfit Adventure (RFA), (which could deliver optimal exercise intensity for each player and perform fine-tuned up- and downregulation based on performance after each game), among older adults in rural care facilities in this current study.
Methods:
The investigators will conduct a prospective randomized controlled trial (RCT) comparing an exergame-based multicomponent training (Exergame-based REH) to standard of care in older users of LTCF in Ci-Shan and Mei-Nong district, Kaohsiung city, Taiwan. Participants in the intervention group will receive standard care with additional exergame-based REH for 12 weeks, while participants in the control group will receive standard care that routinely applied in the long term care facilities as usual. The Exergame-based REH contains progressive resistance training and functional movement of the four extremities but mainly upper limbs. The investigators will use the commercialized exergame Ringfit Adventure (RFA) to deliver the program. The Exergame-based REH will be performed twice per week, at least 48 hours apart from each training session, 50 minutes (10 minutes for warm-up and cool-down, 30 minutes for main program) per time, for a total 12 weeks. Criteria of sarcopenia including (1) handgrip strength of dominant hand (HGS), (2) walking speed, and (3) appendicular skeletal muscle mass index of 4 extremities (ASMMI), and study of osteoporotic fractures index, will be measured as primary outcomes. (1) Range of motions in dominant upper extremity (ROM), (2) maximal voluntary isometric contraction of biceps/triceps brachial muscles of dominant side (MVC of biceps/triceps), (3) box and block test (BBT), (4) Sonographic thickness of Biceps and Triceps Brachii muscles, (5) Kihon checklist-Taiwan version, (6) 36-Item Short Form Survey questionnaire (SF-36), and (7) brain health test (BHT) will be measured as secondary outcomes before, during, and after the programs.
Hypothesis
1. After three months of participating in the Exergame-based REH, the primary outcomes will show statistically significant increase.
2. After three months of participating in the Exergame-based REH, the secondary outcomes will show statistically significant increase.
Flow of the research:
Participants meet the inclusion criteria are first selected from the long term care facilities (including daycare centers and nursing homes) in Chi-Shan and Mei-Nong districts in rural Kaohsiung city.
The participants are classified into the intervention and control group randomly.
All the outcomes measured are done at the baseline (pre-test), 6 weeks after the intervention (mid-term evaluation), and 3 months after the intervention (post-test).
Apparatus in this study:
Nintendo Switch® RingFit Adventrue with RIng-Con and Joy-con. InBody S10 Body Composition \& Scale JAMAR Hand Dynamometer MicroFET3 Dynamometer and range of motion evaluator Goniometer Box and Block Test Apparatus A portable LOGIQ e ultrasound (General Electric Company, U.S.A., 2010), equipped with a 5-12 MHz linear array transducer
Conditions
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Study Design
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RANDOMIZED
PARALLEL
@Control group: Participants in the control group received standard care that applied as usual in the LTCFs, in the way of group activities, including calisthenics (that could be performed in the sitting position), horticultural therapy, and group static activities (e.g., tabletop games). The programs were performed two times per week for approximately 30-60 min, depending on the activity, and will be led by a therapist.
PREVENTION
SINGLE
Study Groups
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Intervention group
The intervention in this group is standard care plus plus exergame-based multicomponent training program
Standard care plus plus Exergame-based multicomponent training program
The program contains PRT and functional movement of the four extremities but mainly upper limbs. We will use the commercialized exergame Ringfit Adventure (RFA) to deliver the program.
RFA is a fitness action role-playing game. The player advances the story while exercising as the movement of the player is linked to the main character on the screen. The movements of the player and battle actions are based on performing certain physical activities using the Ring-Con and Leg Strap. RFA itself could estimate the optimal exercise intensity for each player and performs fine-tuned up-and downregulation based on these physiological feedbacks. Therefore, it has become possible to provide an appropriate amount of exercise for all generations from children to the elderly.
The standard care is applied as usual in our LTCF. (descriped as the below in the control group)
Control group
The control group receives usual care in the LTCFs.
Standard care
The standard care in the control group is applied as usual in our LTCF, in the way of group activity, including calisthenics (that could be done in sitting position), horticultural therapy, and group activity of peace (like tabletop games). The programs are performed twice per week, about 30 to 60 minutes (depends on different activity), leading by a therapist.
Interventions
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Standard care plus plus Exergame-based multicomponent training program
The program contains PRT and functional movement of the four extremities but mainly upper limbs. We will use the commercialized exergame Ringfit Adventure (RFA) to deliver the program.
RFA is a fitness action role-playing game. The player advances the story while exercising as the movement of the player is linked to the main character on the screen. The movements of the player and battle actions are based on performing certain physical activities using the Ring-Con and Leg Strap. RFA itself could estimate the optimal exercise intensity for each player and performs fine-tuned up-and downregulation based on these physiological feedbacks. Therefore, it has become possible to provide an appropriate amount of exercise for all generations from children to the elderly.
The standard care is applied as usual in our LTCF. (descriped as the below in the control group)
Standard care
The standard care in the control group is applied as usual in our LTCF, in the way of group activity, including calisthenics (that could be done in sitting position), horticultural therapy, and group activity of peace (like tabletop games). The programs are performed twice per week, about 30 to 60 minutes (depends on different activity), leading by a therapist.
Eligibility Criteria
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Inclusion Criteria
* those living or participating in LTCFs for at least 1 month
* those who can understand and speak Chinese or Taiwanese
* those with sufficient cognitive capacity (judged by the researchers) to give informed consent and participate in the exergame-based REH and data collection
* those who can sit for more than 50 min for training and can complete the measurement of gait speed.
Exclusion Criteria
* those regularly receiving oxygen supplementation
* those who have uncontrollable hypertension
* those who had a recent infection or fracture or were diagnosed with other diseases that might prohibit them from participating in exercises according to the guidelines of the American College of Sports Medicine.
60 Years
100 Years
ALL
No
Sponsors
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Cishan Hospital, Ministry of Health and Welfare
OTHER
Responsible Party
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Sheng-Hui Tuan
Attending physicain
Principal Investigators
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Sheng-Hui Tuan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ci-Shan hospital, Ministry of Health and Welfare
Locations
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Cishan Hospital, Ministry of health and welfare
Kaohsiung City, , Taiwan
Countries
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References
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Evans WJ. Skeletal muscle loss: cachexia, sarcopenia, and inactivity. Am J Clin Nutr. 2010 Apr;91(4):1123S-1127S. doi: 10.3945/ajcn.2010.28608A. Epub 2010 Feb 17.
Seene T, Kaasik P, Riso EM. Review on aging, unloading and reloading: changes in skeletal muscle quantity and quality. Arch Gerontol Geriatr. 2012 Mar-Apr;54(2):374-80. doi: 10.1016/j.archger.2011.05.002. Epub 2011 May 31.
Chang CF, Yeh YL, Chang HY, Tsai SH, Wang JY. Prevalence and Risk Factors of Sarcopenia among Older Adults Aged >/=65 Years Admitted to Daycare Centers of Taiwan: Using AWGS 2019 Guidelines. Int J Environ Res Public Health. 2021 Aug 5;18(16):8299. doi: 10.3390/ijerph18168299.
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Meekes W, Stanmore EK. Motivational Determinants of Exergame Participation for Older People in Assisted Living Facilities: Mixed-Methods Study. J Med Internet Res. 2017 Jul 6;19(7):e238. doi: 10.2196/jmir.6841.
Jahouh M, Gonzalez-Bernal JJ, Gonzalez-Santos J, Fernandez-Lazaro D, Soto-Camara R, Mielgo-Ayuso J. Impact of an Intervention with Wii Video Games on the Autonomy of Activities of Daily Living and Psychological-Cognitive Components in the Institutionalized Elderly. Int J Environ Res Public Health. 2021 Feb 7;18(4):1570. doi: 10.3390/ijerph18041570.
Gunst M, De Meyere I, Willems H, Schoenmakers B. Effect of exergaming on wellbeing of residents in a nursing home: a single blinded intervention study. Aging Clin Exp Res. 2022 Jan;34(1):151-157. doi: 10.1007/s40520-021-01903-1. Epub 2021 Jun 22.
Sato T, Shimizu K, Shiko Y, Kawasaki Y, Orita S, Inage K, Shiga Y, Suzuki M, Sato M, Enomoto K, Takaoka H, Mizuki N, Kim G, Hozumi T, Tsuchiya R, Otagiri T, Mukaihata T, Furuya T, Maki S, Nakamura J, Hagiwara S, Aoki Y, Koda M, Akazawa T, Takahashi H, Takahashi K, Ohtori S, Eguchi Y. Effects of Nintendo Ring Fit Adventure Exergame on Pain and Psychological Factors in Patients with Chronic Low Back Pain. Games Health J. 2021 Jun;10(3):158-164. doi: 10.1089/g4h.2020.0180. Epub 2021 Apr 22.
Chen GB, Lin CW, Huang HY, Wu YJ, Su HT, Sun SF, Tuan SH. Using Virtual Reality-Based Rehabilitation in Sarcopenic Older Adults in Rural Health Care Facilities-A Quasi-Experimental Study. J Aging Phys Act. 2021 Oct 1;29(5):866-877. doi: 10.1123/japa.2020-0222. Epub 2021 Feb 16.
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Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.
Ensrud KE, Ewing SK, Cawthon PM, Fink HA, Taylor BC, Cauley JA, Dam TT, Marshall LM, Orwoll ES, Cummings SR; Osteoporotic Fractures in Men Research Group. A comparison of frailty indexes for the prediction of falls, disability, fractures, and mortality in older men. J Am Geriatr Soc. 2009 Mar;57(3):492-8. doi: 10.1111/j.1532-5415.2009.02137.x. Epub 2009 Feb 22.
Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.
Tuan SH, Chang LH, Sun SF, Li CH, Chen GB, Tsai YJ. Assessing the Clinical Effectiveness of an Exergame-Based Exercise Training Program Using Ring Fit Adventure to Prevent and Postpone Frailty and Sarcopenia Among Older Adults in Rural Long-Term Care Facilities: Randomized Controlled Trial. J Med Internet Res. 2024 Jul 18;26:e59468. doi: 10.2196/59468.
Tuan SH, Chang LH, Sun SF, Lin KL, Tsai YJ. Using exergame-based exercise to prevent and postpone the loss of muscle mass, muscle strength, cognition, and functional performance among elders in rural long-term care facilities: A protocol for a randomized controlled trial. Front Med (Lausanne). 2022 Dec 13;9:1071409. doi: 10.3389/fmed.2022.1071409. eCollection 2022.
Other Identifiers
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22-01
Identifier Type: -
Identifier Source: org_study_id
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