The Effectiveness of Training Using Exergaming on Selected Physical and Psychological Parameters in a Population of Patients Over the Age of 65 Belonging to Specific Subgroups of the Frailty Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Change in Frailty Category Based on Fried Frailty Phenotype Criteria
研究概览
简要总结
This study aims to evaluate the effects of a six-week exergaming-based training program on physical and psychological parameters in individuals aged 65 and older diagnosed with frailty or pre-frailty. Participants engage in supervised exergame sessions twice weekly using the Activlife rehabilitation platform, which combines physical exercises with cognitive tasks in a virtual environment. Outcomes are assessed using validated tools including the Fried Frailty Criteria, CES-D, IPAQ-SF, Katz ADL, Lawton IADL, VES-13, Tinetti Test, and Fullerton Fitness Test. Anthropometric and functional data are collected before and after the intervention.
详细描述
Frailty is a clinical syndrome marked by reduced physiological reserve and increased vulnerability to adverse outcomes. Exergaming-interactive video game-based physical activity-offers a novel and potentially effective approach to counteracting physical and cognitive decline in frail older adults. While promising, existing evidence remains limited and methodologically heterogeneous.
This single-center trial investigates the effects of a six-week structured exergame training program on physical performance, functional independence, cognitive function, and mental well-being in a population of individuals aged 65+ with pre-frailty or frailty syndrome according to the Fried criteria.
Participants engage in at least 30-minute exergame-based sessions twice per week using the Activlife rehabilitation platform. The platform combines Kinect-based motion tracking with immersive therapeutic games that include physical (strength, balance, endurance) and cognitive (memory, visuospatial, logic) tasks. Sessions are supervised by a trained therapist, and game difficulty is adapted biweekly to participant capacity.
Assessments are conducted pre- and post-intervention and include: anthropometric data, frailty status (Fried criteria), depression symptoms (CES-D), physical activity (IPAQ-SF), basic and instrumental activities of daily living (Katz ADL, Lawton IADL), vulnerability (VES-13), mobility and balance (Tinetti Test), and physical fitness (Fullerton Fitness Test).
Ethical approval was obtained from the Bioethics Committee of Wroclaw Medical University (approval no. 172/2019). All participants provided written informed consent. The study adheres to the Declaration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no medical contraindications to performing physical exercises in a standing position
排除标准
- •diagnosed moderate or severe stage of dementia
- •the presence of chronic diseases (e.g. chronic obstructive pulmonary disease, asthma, heart failure, arterial hypertension) that were uncontrolled or in an exacerbation phase
结局指标
主要结局
Change in Frailty Category Based on Fried Frailty Phenotype Criteria
时间窗: Baseline and through completion of exergaming training program (an average of 6 weeks)
Frailty status will be assessed using the Fried Frailty Phenotype, which includes five criteria: unintentional weight loss, weakness (handgrip strength), slowness (gait speed), exhaustion (CES-D), and low physical activity (IPAQ-SF). Each criterion met scores 1 point (range: 0-5). Participants are classified as: robust (0 points), pre-frail (1-2 points), or frail (≥3 points). The outcome is the change in frailty category from baseline to study completion. Improvement is defined as transition to a lower-risk category (e.g., frail to pre-frail), while worsening is a shift to a higher-risk category. A decrease in frailty category indicates improvement.
次要结局
- Health-Related Quality of Life Assessed by the Short Form-36 (SF-36) Health Survey(Baseline and through completion of exergaming training program (an average of 6 weeks))
- Functional Vulnerability Assessed by the Vulnerable Elders Survey-13 (VES-13)(Baseline and through completion of exergaming training program (an average of 6 weeks))
- Frailty Score Assessed by Fried Frailty Phenotype Scale(Baseline and through completion of exergaming training program (an average of 6 weeks))
- Depression Symptoms Assessed by the Geriatric Depression Scale (GDS-15)(Baseline and through completion of exergaming training program (an average of 6 weeks))
- Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)(Baseline and through completion of exergaming training program (an average of 6 weeks))
- Functional Status Assessed by the Katz Index of Independence in Activities of Daily Living (ADL)(Baseline and through completion of exergaming training program (an average of 6 weeks))
- Instrumental Activities of Daily Living Assessed by the Lawton-Brody Scale (IADL)(Baseline and through completion of exergaming training program (an average of 6 weeks))
- Physical Fitness Assessed by the Fullerton Fitness Test (Senior Fitness Test)(Baseline and through completion of exergaming training program (an average of 6 weeks))
- Balance and Gait Assessed by the Tinetti Performance-Oriented Mobility Assessment (POMA)(Baseline and through completion of exergaming training program (an average of 6 weeks))