Effects of Active Exergames Program on Muscle Strength, Lower Limb Muscle Mass and Physical Fitness in Older Adults at Risk of Falls
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Dynamic balance
研究概览
简要总结
The goal of this randomized clinical trial is to analyze the effectiveness of a physical exercise program based on exergames combined with conventional physical therapy, compared to a conventional physical exercise program alone, in improving lower limb strength, muscle quality, and physical capacity in older adults at risk of falling. The main questions it aims to answer are:
Does a combined exergame and conventional exercise program improve functional capacity in older adults at risk of falling more than traditional exercise alone? Does the intervention improve lower limb strength and muscle quality more effectively than conventional exercise alone?
Researchers will compare a group receiving exergame-based exercise combined with conventional therapy to a group receiving conventional physical exercise only to see if the addition of exergames enhances functional outcomes and muscle performance.
Participants will:
- Undergo baseline and post-intervention assessments of lower limb strength, muscle quality, and physical capacity.
- Participate in a structured physical exercise program.
- In the intervention group, perform exergame-based exercises using virtual reality gaming systems such as Nintendo Switch (Ring Fit Adventure).
- Engage in sessions for several weeks, with consistent frequency and intensity depending on the group allocation.
详细描述
Falls in older adults have been associated with a decrease in physical activity, the level of functionality and an increase in dependency. Furthermore, falls and their consequences are one of the main causes of mortality among older people. Falls are more frequent in women, in people over 75 years of age and with sensory deficits.
Currently, there are promising and novel solutions to prevent and/or avoid the repetition of falls; Among them, the use of active exergames stands out. Active exergames can be developed in health, community, sports centers or in a homeroom individually or in groups using a screen through video games that involve the movement of the whole body, like the real world with or without the use of a controller that allows you to execute movements in a small space and interact with the game scenario. They have been shown to be useful for improving balance and physical condition in people of different ages and health conditions, but there is little evidence of studies that analyze the effects of this therapeutic strategy in older adults at risk of falling.
Active exergames are a novel, simple, motivating, and easy-to-implement treatment option to promote healthy aging and prevent the risk of falls in older people. Therefore, it has the potential to become, in the short term, a therapeutic strategy for mass use, with high adherence and low cost in health centers.
Exergames have an affordable cost, with a wide variety of games and are easy to use, therefore it is increasingly accepted by different types of patients as a therapeutic strategy.
The evidence indicates that, both programs are expected to improve the primary and secondary outcomes proposed in this project. Additionally, older adults who execute an active exergame program are expected to have better performance compared to a conventional physiotherapy program in the main outcome and the secondary outcomes analyzed. It is expected to promote the use of active exergames by rehabilitation professionals in primary health care centers to prevent falls in older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 60 years or older
- •Both sexes eligible
- •Attendees of SENAMA day centers (senior care centers) in the Metropolitan Region of Santiago, Chile.
- •Mini-Mental State Examination (MMSE) score > 14
- •Barthel Index score > 60 (indicating moderate to good functional independence)
- •No self-reported medical contraindications for physical exercise
- •Ability to walk independently (with or without assistive devices)
- •Provided written informed consent
排除标准
- •Recent bone fractures or acute myocardial infarction
- •Severe cardiovascular or respiratory conditions
- •Uncontrolled hypertension or diabetes mellitus
- •Cognitive or sensory impairments that limit instruction comprehension
- •Participation in other exercise programs during the study period
- •Inability to attend at least 80% of the intervention sessions
研究组 & 干预措施
Exergame-Based Exercise + Conventional Physical Therapy group
Participants in this group will receive a combined intervention that includes multicomponent physical exercise and training using exergames (specifically Ring Fit Adventure on the Nintendo Switch). The sessions target strength, balance, and aerobic capacity and will be delivered twice a week for 12 weeks in senior care centers.
干预措施: Exergame-Based Exercise + Conventional Physical Therapy (Behavioral)
Conventional Physical Therapy Group
Participants in this group will receive a standard multicomponent physical exercise program including aerobic, strength, balance, and flexibility exercises, delivered twice a week for 12 weeks in senior care centers. No exergames or virtual reality components will be included in this intervention.
干预措施: Conventional Physical Therapy (Behavioral)
结局指标
主要结局
Dynamic balance
时间窗: Baseline and 12 weeks post-intervention
Dynamic balance is measured with the Timed Up and Go (TUG) test, which evaluates the time in seconds that a participant takes to rise from a chair, walk 3 meters, turn, return, and sit down again.
Risk of fall
时间窗: Baseline and 12 weeks post-intervention
Fall risk will be evaluated using the Downton Fall Risk Index (DFRI), a 5-item composite score based on prior falls, medication, sensory deficits, mental state, and mobility. A total score \>3 indicates high fall risk.
Functional Independence
时间窗: Baseline and 12 weeks post-intervention
Functional independence will be measured with FIM scale, it consists of 18 items that assess both motor and cognitive skills, and is scored on a 7-level scale, where 1 indicates total dependence and 7 complete independence.
Center of Pressure (COP)
时间窗: Baseline and 12 weeks post-intervention
Posturography, which records center of pressure displacement while standing on a stable platform.
Aerobic capacity
时间窗: Baseline and 12 weeks post-intervention
Aerobic capacity is assessed by the 2-Minute Walk Test, which measures the total distance (in meters) covered at a self-selected walking pace within 2 minutes on a flat surface.
Static balance
时间窗: Baseline and 12 weeks post-intervention
Single-Leg Stance Test (Unipedal Stance Test), where participants must maintain balance on one leg for at least 5 seconds.
次要结局
- body composition(Baseline and 12 weeks post-intervention)
- Handgrip strength(Baseline and 12 weeks post-intervention)
- Lower Limb Muscle Strength(Baseline and 12 weeks post-intervention)
- Intramuscular Fat Infiltration(Baseline and 12 weeks post-intervention)
- Muscle Architecture(Baseline and 12 weeks post-intervention)