Using Exergame-based Program in Elders of Rural LTCF

NCT05360667 | Completed

• 1 other identifier: 22-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Frailty; Long Term Care Facility

Keywords

long-term care; exergame; RingFit Adventure; elderly; appendicular skeletal muscle index; Study of Osteoporotic Fractures Index

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Box and Block Test (BBT)

  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

  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

  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

  baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)

• General function

  baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week)

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention in this group is standard care plus plus exergame-based multicomponent training program

Other: Standard care plus plus Exergame-based multicomponent training program

Control group

SHAM COMPARATOR

The control group receives usual care in the LTCFs.

Other: Standard care

Interventions

Standard care plus plus Exergame-based multicomponent training program OTHER

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)

Intervention group

Standard care OTHER

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.

Control group

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cishan Hospital, Ministry of Health and Welfare: lead

Study Sites (1)

Cishan Hospital, Ministry of health and welfare

Kaohsiung City, 84247, Taiwan

Location

Related Publications (18)

• 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.

  PMID: 20164314 BACKGROUND

• 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.

  PMID: 21632125 BACKGROUND

• 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.

  PMID: 34444047 BACKGROUND

• 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.

  PMID: 31277132 BACKGROUND

• 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.

  PMID: 31455563 BACKGROUND

• 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.

  PMID: 32033882 BACKGROUND

• 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.

  PMID: 28684385 BACKGROUND

• 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.

  PMID: 33562249 BACKGROUND

• 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.

  PMID: 34156650 BACKGROUND

• 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.

  PMID: 33891508 BACKGROUND

• 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.

  PMID: 33596540 BACKGROUND

• 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.

  PMID: 33732549 BACKGROUND

• 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.

  PMID: 31730754 BACKGROUND

• 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.

  PMID: 19245414 BACKGROUND

• 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.

  PMID: 8024419 BACKGROUND

• 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.

  PMID: 21570036 BACKGROUND

• Tuan SH, Chang LH, Sun SF, Li CH, Chen GB, Tsai YJ. Assessing the Clinical Effectiveness of an Exergame-Based Exercise Training Program Using Ring Fit Adventure to Prevent and Postpone Frailty and Sarcopenia Among Older Adults in Rural Long-Term Care Facilities: Randomized Controlled Trial. J Med Internet Res. 2024 Jul 18;26:e59468. doi: 10.2196/59468.

  PMID: 39024000 DERIVED

• Tuan SH, Chang LH, Sun SF, Lin KL, Tsai YJ. Using exergame-based exercise to prevent and postpone the loss of muscle mass, muscle strength, cognition, and functional performance among elders in rural long-term care facilities: A protocol for a randomized controlled trial. Front Med (Lausanne). 2022 Dec 13;9:1071409. doi: 10.3389/fmed.2022.1071409. eCollection 2022.

  PMID: 36582297 DERIVED

MeSH Terms

Conditions

Sarcopenia; Frailty

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sheng-Hui Tuan, M.D.

  Ci-Shan hospital, Ministry of Health and Welfare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because of the design of the study and the nature of the interventions, blinding the staff and participants of the LTCFs is impossible. The assessors, measuring the outcomes, and the interpreter, analyzing the data, will be blinded in this study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physicain

Model Details: @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.

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 4, 2022
• Study Start: August 26, 2022
• Primary Completion: July 27, 2023
• Study Completion: December 31, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after the official publication.
• Access Criteria: Please e-mail to the primary investigator on reasonable request after the publication.

Locations

TW (1)