Using Exergame-based Program in Elders of Rural LTCF
Condition: Sarcopenia; Frailty; Long Term Care Facility
MeSH terms: Sarcopenia; Frailty
Study type: Interventional

Summary: 
      Background:

      Sarcopenia is the progressive loss of skeletal muscle mass and decline of muscle function
      associated with aging. Frailty is defined as a clinically recognizable state of increased
      vulnerability resulting from aging-associated decline in reserve and function across multiple
      physiologic systems. Resistant, aerobic, and multi-component exercise could improve muscle
      strength and function in older adults. Some policies have been proposed and implemented to
      prevent and delay the frailty and disability among elders in long term care policy in Taiwan.
      However, due to shortage in healthcare provider, long-term exercise program is difficult to
      provide in long-term care facilities (LTCF) of countryside in Taiwan.

      Method:

      This will be a prospective randomized controlled trial comparing an exergame-based
      multicomponent training (Exergame-based REH) to standard of care in older users of LTCF in
      rural Kaohsiung city, Taiwan. Participants in the intervention group will receive
      Exergame-based REH for 12 weeks, while participants in the control group will receive
      standard care that routinely applied in the LTFC as usual. The Exergame-based REH contains
      progressive resistance training and functional movement of the four extremities but mainly
      upper limbs. The investigators will use the Ringfit Adventure to deliver the program. The
      Exergame-based REH will be performed twice per week, at least 48 hours apart from each
      training session, 50 minutes per time, for a total 12 weeks. Criteria of sarcopenia including
      (1) handgrip strength of dominant hand, (2) walking speed, and (3) appendicular skeletal
      muscle mass index of 4 extremities, and Study of osteoporotic fractures index, will be
      measured as primary outcomes. (1) Range of motions in dominant upper extremity, (2) maximal
      voluntary isometric contraction of biceps/triceps brachial muscles of dominant side, (3) box
      and block test, (4) Sonographic thickness of Biceps and Triceps Brachii muscles, (5) Kihon
      checklist-Taiwan version, (6) 36-Item Short Form Survey questionnaire, and (7) brain health
      test, will be measured as secondary outcomes before and after the programs.

      Anticipated benefits:

      The Exergame-based REH could enhance the motivation toward exercise of older adults. It could
      also increase muscle mass, strength, functional ability of dominant upper extremity, and
      health-related quality of life.
    

Detailed description: 
      Background:

      Sarcopenia is the progressive loss of skeletal muscle mass and decline of muscle function
      associated with aging. The prevalence of sarcopenia among people older than 65 years old in
      Taiwan is over 20%. Sarcopenia is one of the most important causes of functional decline and
      loss of independence, even mortality in older adults. Frailty is theoretically defined as a
      clinically recognizable state of increased vulnerability resulting from aging-associated
      decline in reserve and function across multiple physiologic systems such that the ability to
      cope with everyday or acute stressors is comprised. Both sarcopenia and frailty are getting
      more and more concerns in Taiwan, which is now an aged-society. Resistant, aerobic, and
      multi-component exercise have been proved to improve muscle strength and function in older
      adults.

      The principles of progressive resistance training and multi-component exercise programs
      include regular, mass-practiced, mild overwhelming engagement. These principles demand
      devoting time, workforce, and money to achieve. Staffing constraints and resources shortage
      have made it challenging to promote regular exercise programs in long-term care facilities.
      Exergames have been defined as any type of video game that requires the movement of the
      player's entire body, allowing real-time interaction. Exergames breaks down the barriers of
      repetitive and monotonous physical exercise since they contain attractive and multisensory
      game environments with an immersive environment in which the interaction takes place through
      global body movements. Moreover, the gamified approach and immersive scenarios motivate older
      people to acquire a greater commitment to the practice of physical and rehabilitative
      exercises. Therefore, by playing exergames, it reduces staff time for intervention,
      encourages patients to perform relatively high-energy movements, and increase participants'
      motivation.

      Therefore, investigators in this study aim to evaluate the feasibility and clinical
      application of a novel exergame-based multicomponent training via Nintendo Switch® Ringfit
      Adventure (RFA), (which could deliver optimal exercise intensity for each player and perform
      fine-tuned up- and downregulation based on performance after each game), among older adults
      in rural care facilities in this current study.

      Methods:

      The investigators will conduct a prospective randomized controlled trial (RCT) comparing an
      exergame-based multicomponent training (Exergame-based REH) to standard of care in older
      users of LTCF in Ci-Shan and Mei-Nong district, Kaohsiung city, Taiwan. Participants in the
      intervention group will receive standard care with additional exergame-based REH for 12
      weeks, while participants in the control group will receive standard care that routinely
      applied in the long term care facilities as usual. The Exergame-based REH contains
      progressive resistance training and functional movement of the four extremities but mainly
      upper limbs. The investigators will use the commercialized exergame Ringfit Adventure (RFA)
      to deliver the program. The Exergame-based REH will be performed twice per week, at least 48
      hours apart from each training session, 50 minutes (10 minutes for warm-up and cool-down, 30
      minutes for main program) per time, for a total 12 weeks. Criteria of sarcopenia including
      (1) handgrip strength of dominant hand (HGS), (2) walking speed, and (3) appendicular
      skeletal muscle mass index of 4 extremities (ASMMI), and study of osteoporotic fractures
      index, will be measured as primary outcomes. (1) Range of motions in dominant upper extremity
      (ROM), (2) maximal voluntary isometric contraction of biceps/triceps brachial muscles of
      dominant side (MVC of biceps/triceps), (3) box and block test (BBT), (4) Sonographic
      thickness of Biceps and Triceps Brachii muscles, (5) Kihon checklist-Taiwan version, (6)
      36-Item Short Form Survey questionnaire (SF-36), and (7) brain health test (BHT) will be
      measured as secondary outcomes before, during, and after the programs.

      Hypothesis

        1. After three months of participating in the Exergame-based REH, the primary outcomes will
           show statistically significant increase.

        2. After three months of participating in the Exergame-based REH, the secondary outcomes
           will show statistically significant increase.

      Flow of the research:

      Participants meet the inclusion criteria are first selected from the long term care
      facilities (including daycare centers and nursing homes) in Chi-Shan and Mei-Nong districts
      in rural Kaohsiung city.

      The participants are classified into the intervention and control group randomly.

      All the outcomes measured are done at the baseline (pre-test), 6 weeks after the intervention
      (mid-term evaluation), and 3 months after the intervention (post-test).

      Apparatus in this study:

      Nintendo Switch® RingFit Adventrue with RIng-Con and Joy-con. InBody S10 Body Composition &
      Scale JAMAR Hand Dynamometer MicroFET3 Dynamometer and range of motion evaluator Goniometer
      Box and Block Test Apparatus A portable LOGIQ e ultrasound (General Electric Company, U.S.A.,
      2010), equipped with a 5-12 MHz linear array transducer
    

Intervention name(s): Standard care plus plus Exergame-based multicomponent training program; Standard care
Intervention type(s): Other; Other
Intervention description(s): 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); 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: @Intervention group: The program consists of PRT and functional movement of the four extremities but mainly the upper limbs. We used RFA to deliver the program. The exergame-based exercise were performed two times per week, at least 48 h apart from each training session, 50 min per session (10 min each for a warm-up and cool-down and 30 min for the main program), for 12 weeks, and will be supervised by a therapist.
@Control group: Participants in the control group received standard care that applied as usual in the LTCFs, in the way of group activities, including calisthenics (that could be performed in the sitting position), horticultural therapy, and group static activities (e.g., tabletop games). The programs were performed two times per week for approximately 30-60 min, depending on the activity, and will be led by a therapist.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: long-term care; exergame; RingFit Adventure; elderly; appendicular skeletal muscle index; Study of Osteoporotic Fractures Index