Clinical trial NCT05360667: Using Exergame-based Program in Elders of Rural LTCF
Official title: The Clinical Effectiveness of Exergame-based Exercise Training in the Prevention of Fragile Syndrome and Sarcopenia Among Elders in Rural Long-term Care Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Frailty
Long Term Care Facility
Keywords: long-term care
exergame
RingFit Adventure
elderly
appendicular skeletal muscle index
Study of Osteoporotic Fractures Index
Lead sponsor: Cishan Hospital, Ministry of Health and Welfare
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: @Intervention group: The program consists of PRT and functional movement of the four extremities but mainly the upper limbs. We used RFA to deliver the program. The exergame-based exercise were performed two times per week, at least 48 h apart from each training session, 50 min per session (10 min each for a warm-up and cool-down and 30 min for the main program), for 12 weeks, and will be supervised by a therapist.

@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.
Primary purpose: PREVENTION

Brief summary: Background:

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.

Detailed description: Background:

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

Eligibility criteria: Inclusion Criteria:

* individuals aged ≥60 years
* 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:

* Individuals who have significant cardiopulmonary diseases
* 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.

Primary outcomes:
measure: Change of anthropometry and body composition (T2-T0)
timeFrame: Change from baseline appendicular skeletal muscle mass index at the end of the 12th weeks
measure: Change of anthropometry and body composition (T1-T0)
timeFrame: Change from baseline appendicular skeletal muscle mass index at the end of the 6th weeks
measure: Change of anthropometry and body composition (T2-T1)
timeFrame: Change of appendicular skeletal muscle mass index between the 6th week and the 12th week
measure: Dominant Hand Grip Strength (HGS) (T2-T0)
timeFrame: Change from baseline HGS at the end of 12th weeks
measure: Dominant Hand Grip Strength (HGS) (T1-T0)
timeFrame: Change from baseline appendicular skeletal muscle mass index at the end of the 6th weeks
measure: Dominant Hand Grip Strength (HGS) (T2-T1)
timeFrame: Change of HGS between the end of the 6th week and the 12th week
measure: Gait Speed (T2-T0)
timeFrame: Change from baseline gait speed at the end of the 12th weeks
measure: Gait Speed (T1-T0)
timeFrame: Change from baseline gait speed at the end of the 6th weeks
measure: Gait Speed (T2-T1)
timeFrame: Change of gait speed between the end of the 6th week and the 12th week
measure: Study of Osteoporotic Fractures Index (SOF index) (T2-T0)
timeFrame: Change from baseline SOF index at the end of the 12th weeks
measure: Study of Osteoporotic Fractures Index (SOF index) (T1-T0)
timeFrame: Change from baseline SOF index at the end of the 6th weeks
measure: Study of Osteoporotic Fractures Index (SOF index) (T2-T1)
timeFrame: Change of SOF index between the end of the 6th week and the 12th week
Secondary outcomes:
measure: Box and Block Test (BBT)
timeFrame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
measure: Biceps and Triceps Brachii Muscle Strength of the dominant side
timeFrame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
measure: Sonographic thickness of Biceps and Triceps Brachii muscles
timeFrame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
measure: Measurement of the range of motion (ROM) of the Joints of Dominant Upper Extremity
timeFrame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
measure: General function
timeFrame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
measure: Health-related Quality of Life (HQoL)
timeFrame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
measure: Cognitive level
timeFrame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Cishan Hospital, Ministry of health and welfare
Study officials:
affiliation: Ci-Shan hospital, Ministry of Health and Welfare
name: Sheng-Hui Tuan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Thomas E, Battaglia G, Patti A, Brusa J, Leonardi V, Palma A, Bellafiore M. Physical activity programs for balance and fall prevention in elderly: A systematic review. Medicine (Baltimore). 2019 Jul;98(27):e16218. doi: 10.1097/MD.0000000000016218.
citation: Hsu HC, Chen CF. LTC 2.0: The 2017 reform of home- and community-based long-term care in Taiwan. Health Policy. 2019 Oct;123(10):912-916. doi: 10.1016/j.healthpol.2019.08.004. Epub 2019 Aug 20.
citation: Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Choi HJ, Ko CY, Chang Y, Kim GS, Choi K, Kim CH. Development and validation of bioimpedance prediction equations for fat-free mass in unilateral male amputees. PeerJ. 2021 Mar 8;9:e10970. doi: 10.7717/peerj.10970. eCollection 2021.
citation: 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.
citation: 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.
citation: 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.
citation: 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.