Using Exergame-based Program in Elders of Rural LTCF

C

Cishan Hospital, Ministry of Health and Welfare

Status

Completed

Conditions

Frailty
Sarcopenia
Long Term Care Facility

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05360667
22-01

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

60 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Intervention group
Experimental group
Description:
The intervention in this group is standard care plus plus exergame-based multicomponent training program
Treatment:
Other: Standard care plus plus Exergame-based multicomponent training program
Control group
Sham Comparator group
Description:
The control group receives usual care in the LTCFs.
Treatment:
Other: Standard care

Trial contacts and locations

1

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Central trial contact

Sheng-Hui Tuan, M.D.

Data sourced from clinicaltrials.gov

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