The Clinical Effectiveness of Exergame-based Exercise Training in the Prevention of Fragile Syndrome and Sarcopenia Among Elders in Rural Long-term Care Facilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Gait Speed (T2-T1)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Gait Speed (T2-T1)
时间窗: 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.
Dominant Hand Grip Strength (HGS) (T1-T0)
时间窗: 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.
Change of anthropometry and body composition (T1-T0)
时间窗: 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)
时间窗: 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)
时间窗: 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.
Study of Osteoporotic Fractures Index (SOF index) (T2-T1)
时间窗: 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.
Change of anthropometry and body composition (T2-T0)
时间窗: 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).
Study of Osteoporotic Fractures Index (SOF index) (T2-T0)
时间窗: 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.
Dominant Hand Grip Strength (HGS) (T2-T1)
时间窗: 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)
时间窗: 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)
时间窗: 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.
Study of Osteoporotic Fractures Index (SOF index) (T1-T0)
时间窗: 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.
次要结局
- Cognitive level(baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week))
- Box and Block Test (BBT)(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))
- General function(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))
- 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))
- Health-related Quality of Life (HQoL)(baseline (before intervention), during-test (at the end of 6th week), post-test (at the end of 12th week))
研究者
Sheng-Hui Tuan
Attending physicain
Cishan Hospital, Ministry of Health and Welfare