SarcopeniaNCT05360667
Using Exergame-based Program in Elders of Rural LTCF
A study of Sarcopenia and Frailty, run by Cishan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Sarcopenia, Frailty, Long Term Care Facility
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Aug 2022to 31 Dec 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Cishan Hospital, Ministry of health and welfare
Kaohsiung City, 84247
About this study
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
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.
Read more
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.
Read the 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
- After three months of participating in the Exergame-based REH, the primary outcomes will show statistically significant increase.
- 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
- Sarcopenia, Frailty, Long Term Care Facility
- Being tested
- Standard care plus plus Exergame-based multicomponent training program, Standard care
- Keywords
- long-term care, exergame, RingFit Adventure, elderly, appendicular skeletal muscle index, Study of Osteoporotic Fractures Index
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care plus plus Exergame-based multicomponent training programOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention in this group is standard care plus plus exergame-based multicomponent training program Receives: Other: Standard care plus plus Exergame-based multicomponent training program |
| Control group | Sham comparator | The control group receives usual care in the LTCFs. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline appendicular skeletal muscle mass index at the end of the 12th weeks
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).
Measured: Change from baseline appendicular skeletal muscle mass index at the end of the 6th weeks
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).
Measured: Change of appendicular skeletal muscle mass index between the 6th week and the 12th week
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.
Measured: Change from baseline HGS at the end of 12th weeks
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.
Measured: Change from baseline appendicular skeletal muscle mass index at the end of the 6th weeks
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.
Measured: Change of HGS between the end of the 6th week and the 12th week
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.
Measured: Change from baseline gait speed at the end of the 12th weeks
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.
Measured: Change from baseline gait speed at the end of the 6th weeks
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.
Measured: Change of gait speed between the end of the 6th week and the 12th week
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.
Measured: Change from baseline SOF index at the end of the 12th weeks
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.
Measured: Change from baseline SOF index at the end of the 6th weeks
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.
Measured: Change of SOF index between the end of the 6th week and the 12th week
Secondary outcomes (7)
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.
Measured: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
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.
Measured: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
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.
Measured: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
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.
Measured: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
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.
Measured: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
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.
Measured: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
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.
Measured: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start26 Aug 2022
- Primary completion27 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- @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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cishan Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Hui Tuan, Cishan Hospital, Ministry of Health and Welfare
- Investigators
- Sheng-Hui Tuan, M.D., Principal investigator, Ci-Shan hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360667
- Sponsor's protocol ID
- 22-01
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and analysed during the current study are not publicly available since the study is just under construction. The data will be available from the primary investigator on reasonable request after the publication.
Publications
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.
PubMed 20164314Seene 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.
PubMed 21632125Chang 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.
PubMed 34444047Thomas 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.
PubMed 31277132Hsu 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.
PubMed 31455563Chen 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.
PubMed 32033882Meekes 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.
PubMed 28684385Jahouh 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.
PubMed 33562249Gunst 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.
PubMed 34156650Sato 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.
PubMed 33891508Chen 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.
PubMed 33596540Choi 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.
PubMed 33732549Bobos 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.
PubMed 31730754Ensrud 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.
PubMed 19245414Desrosiers 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.
PubMed 8024419
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05360667
- Acronym / sponsor ID
- 22-01
- Conditions
- Sarcopenia, Frailty, Long Term Care Facility
- Keywords
- long-term care, exergame, RingFit Adventure, elderly, appendicular skeletal muscle index, Study of Osteoporotic Fractures Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cishan Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 May 2022 (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.
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
- After three months of participating in the Exergame-based REH, the primary outcomes will show statistically significant increase.
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Standard care plus plus Exergame-based multicomponent training programThe intervention in this group is standard care plus plus exergame-based multicomponent training program |
| Control group | Sham comparator | Other: Standard careThe control group receives usual care in the LTCFs. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Standard care plus plus Exergame-based multicomponent training programThe 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) | Other | Intervention group |
| Standard careThe 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. | Other | Control group |
Primary outcome
Change of anthropometry and body composition (T2-T0)
Time frame: Change from baseline appendicular skeletal muscle mass index at the end of the 12th weeks
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 anthropometry and body composition (T1-T0)
Time frame: Change from baseline appendicular skeletal muscle mass index at the end of the 6th weeks
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 anthropometry and body composition (T2-T1)
Time frame: Change of appendicular skeletal muscle mass index between the 6th week and the 12th week
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).
Dominant Hand Grip Strength (HGS) (T2-T0)
Time frame: Change from baseline HGS at the end of 12th weeks
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.
Dominant Hand Grip Strength (HGS) (T1-T0)
Time frame: Change from baseline appendicular skeletal muscle mass index at the end of the 6th weeks
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.
Dominant Hand Grip Strength (HGS) (T2-T1)
Time frame: Change of HGS between the end of the 6th week and the 12th week
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.
Gait Speed (T2-T0)
Time frame: Change from baseline gait speed at the end of the 12th weeks
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.
Gait Speed (T1-T0)
Time frame: Change from baseline gait speed at the end of the 6th weeks
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.
Gait Speed (T2-T1)
Time frame: Change of gait speed between the end of the 6th week and the 12th week
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.
Study of Osteoporotic Fractures Index (SOF index) (T2-T0)
Time frame: Change from baseline SOF index at the end of the 12th weeks
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.
Study of Osteoporotic Fractures Index (SOF index) (T1-T0)
Time frame: Change from baseline SOF index at the end of the 6th weeks
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.
Study of Osteoporotic Fractures Index (SOF index) (T2-T1)
Time frame: Change of SOF index between the end of the 6th week and the 12th week
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.
7 secondary outcomes
Box and Block Test (BBT)
Time frame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Biceps and Triceps Brachii Muscle Strength of the dominant side
Time frame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Sonographic thickness of Biceps and Triceps Brachii muscles
Time frame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Measurement of the range of motion (ROM) of the Joints of Dominant Upper Extremity
Time frame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
General function
Time frame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Health-related Quality of Life (HQoL)
Time frame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Cognitive level
Time frame: baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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- Background: PubMed 34444047Chang 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.
- Background: PubMed 31277132Thomas 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.
- Background: PubMed 31455563Hsu 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.
- Background: PubMed 32033882Chen 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.
- Background: PubMed 28684385Meekes 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.
- Background: PubMed 33562249Jahouh 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.
- Background: PubMed 34156650Gunst 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.
- Background: PubMed 33891508Sato 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.
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- Individual participant dataSharing planned: Yes. The datasets generated and analysed during the current study are not publicly available since the study is just under construction. The data will be available from the primary investigator on reasonable request after the publication.
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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.
Sheng-Hui Tuan, M.D. principal investigator
Ci-Shan hospital, Ministry of Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Sarcopenia and Frailty, run by Cishan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 9 Feb 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of anthropometry and body composition (T2-T0) (time frame: Change from baseline appendicular skeletal muscle mass index at the end of the 12th weeks). The study lists 12 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 NCT05360667, which also lists 18 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 9 Feb 2024.