Using Exergame-based Program in Elders of Rural LTCF

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360667
• Other study ID #: 22-01
• Status: Completed
• Phase: N/A
• Start date: August 26, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Cishan Hospital, Ministry of Health and Welfare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Sarcopenia

Intervention

Other:
• 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 ?tness 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 ?ne-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.

Locations

Country	Name	City	State
Taiwan	Cishan Hospital, Ministry of health and welfare	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Cishan Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

References & Publications (16)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of anthropometry and body composition (T2-T0)	We choose bioelectrical impedance analysis to evaluate participants' appendicular skeletal muscle mass. ASMMI was defined as the appendicular skeletal muscle mass (in kilograms) divided by the height squared (in meters squared).	Change from baseline appendicular skeletal muscle mass index at the end of the 12th weeks
Primary	Change of anthropometry and body composition (T1-T0)	We choose bioelectrical impedance analysis to evaluate participants' appendicular skeletal muscle mass. ASMMI was defined as the appendicular skeletal muscle mass (in kilograms) divided by the height squared (in meters squared).	Change from baseline appendicular skeletal muscle mass index at the end of the 6th weeks
Primary	Change of anthropometry and body composition (T2-T1)	We choose bioelectrical impedance analysis to evaluate participants' appendicular skeletal muscle mass. ASMMI was defined as the appendicular skeletal muscle mass (in kilograms) divided by the height squared (in meters squared).	Change of appendicular skeletal muscle mass index between the 6th week and the 12th week
Primary	Dominant Hand Grip Strength (HGS) (T2-T0)	The HGS will be measured by a JAMAR dynamometer (J A Preston, New York, NY) using all five notches. The measurement is done three times and the highest of the three measurements will be recorded. The participants are allowed to rest for 1 min between each measurement.	Change from baseline HGS at the end of 12th weeks
Primary	Dominant Hand Grip Strength (HGS) (T1-T0)	The HGS will be measured by a JAMAR dynamometer (J A Preston, New York, NY) using all five notches. The measurement is done three times and the highest of the three measurements will be recorded. The participants are allowed to rest for 1 min between each measurement.	Change from baseline appendicular skeletal muscle mass index at the end of the 6th weeks
Primary	Dominant Hand Grip Strength (HGS) (T2-T1)	The HGS will be measured by a JAMAR dynamometer (J A Preston, New York, NY) using all five notches. The measurement is done three times and the highest of the three measurements will be recorded. The participants are allowed to rest for 1 min between each measurement.	Change of HGS between the end of the 6th week and the 12th week
Primary	Gait Speed (T2-T0)	The participants are asked to walk a 6-m long corridor without a barrier and the usual gait speed calculated by measuring the time spent by a participant as suggested by ASWG.	Change from baseline gait speed at the end of the 12th weeks
Primary	Gait Speed (T1-T0)	The participants are asked to walk a 6-m long corridor without a barrier and the usual gait speed calculated by measuring the time spent by a participant as suggested by ASWG.	Change from baseline gait speed at the end of the 6th weeks
Primary	Gait Speed (T2-T1)	The participants are asked to walk a 6-m long corridor without a barrier and the usual gait speed calculated by measuring the time spent by a participant as suggested by ASWG.	Change of gait speed between the end of the 6th week and the 12th week
Primary	Study of Osteoporotic Fractures Index (SOF index) (T2-T0)	SOF index composes of the following three components: (a) a weight loss of =5% during the preceding year (regardless of any intention to lose weight), (b) an inability to rise from a chair five times without using the arms, and (c) an answer of 'no' to the question 'Do you feel full of energy?'. Participants are identified to be frail by the presence of two or more of the components, those with one disability are considered to be in pre-frailty status, and those with none of the above impairments are considered to be robust.	Change from baseline SOF index at the end of the 12th weeks
Primary	Study of Osteoporotic Fractures Index (SOF index) (T1-T0)	SOF index composes of the following three components: (a) a weight loss of =5% during the preceding year (regardless of any intention to lose weight), (b) an inability to rise from a chair five times without using the arms, and (c) an answer of 'no' to the question 'Do you feel full of energy?'. Participants are identified to be frail by the presence of two or more of the components, those with one disability are considered to be in pre-frailty status, and those with none of the above impairments are considered to be robust.	Change from baseline SOF index at the end of the 6th weeks
Primary	Study of Osteoporotic Fractures Index (SOF index) (T2-T1)	SOF index composes of the following three components: (a) a weight loss of =5% during the preceding year (regardless of any intention to lose weight), (b) an inability to rise from a chair five times without using the arms, and (c) an answer of 'no' to the question 'Do you feel full of energy?'. Participants are identified to be frail by the presence of two or more of the components, those with one disability are considered to be in pre-frailty status, and those with none of the above impairments are considered to be robust.	Change of SOF index between the end of the 6th week and the 12th week
Secondary	Box and Block Test (BBT)	BBT can be used to measure the unilateral gross manual dexterity in various populations with high test-retest reliability and validity. The setup of BBT comprised a wooden box, divided into two compartments, with 100 wooden blocks inside one compartment.	baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Secondary	Biceps and Triceps Brachii Muscle Strength of the dominant side	We will use the microFET® 3 (Hoggan Health Industries, West Jordan, UT) to The test will bmeasure the maximal voluntary isometric contraction (MVIC) of the biceps and triceps brachii of the dominant side. MicroFET® 3 is an electronic handheld dynamometer that can detect 0-150 lb of force with high reliability and validity(61). The participants lie on the treatment table with their elbows forming a 90° angle to the horizontal such that the arm is perpendicular to the limb. The test will be done under standard positions.	baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Secondary	Sonographic thickness of Biceps and Triceps Brachii muscles	An experienced single operator who is not involved in any further data analysis and is blinded to clinical symptoms, will use a portable LOGIQ e ultrasound (General Electric Company, U.S.A., 2010), equipped with a 5-12 MHz linear array transducer, to measure the muscle thickness under sonography. All the measurements will be done under standard positions.	baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Secondary	Measurement of the range of motion (ROM) of the Joints of Dominant Upper Extremity	The ROMs, including shoulder flexion, abduction, and external rotation; elbow flexion and extension; forearm supination and pronation and wrist flexion and extension, of the dominant upper extremity of the participants are measured. The ROMs measurement is done by a goniometer under standard positions.	baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Secondary	General function	We will use Kihon checklist-Taiwan (KC-T) to indicate the ADLs of the participants in this study. KC-T is a self-reported questionnaire, consisting of 25 items divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside the home, cognitive function, and risk of depression.	baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Secondary	Health-related Quality of Life (HQoL)	We will use the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to indicate the HQoL in this study, The SF-36 is a self-assessment validated generic health survey containing 36 items, divided into 8 subscales, including physical functioning, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health.	baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Secondary	Cognitive level	e will use Brain Health Test (BHT)- brief cognitive test (BHT-Cog) to measure the cognitive level of the participants in this study. The BHT, developed by Taiwan Dementia Society, is a simple dementia screening tool with high validity to assist primary care physicians in identifying patients with cognitive impairment among subjects with memory complaints or at a high risk for dementia.	baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)