Design, Development, and Validation of FEXO: A Playful-Recreational Exercise Intervention for Institutionalized Frail Older Adults to Improve Intrinsic Functional and Cognitive Capacity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intrinsic Capacity (IC)
研究概览
简要总结
This multicenter randomized controlled trial aims to evaluate the effectiveness of a playful multicomponent exercise intervention (FEXO - Fun Exercise for Older Adults) on intrinsic capacity, frailty, and functional health in institutionalized older adults aged over 75. The FEXO program combines aerobic, strength, balance, and flexibility training in a recreational format. Participants will be randomized to an experimental group (receiving the 14-week FEXO program) or a wait-list control group (continuing daily routines). After the first intervention phase, the control group will also complete the program. Primary outcomes include improvements in intrinsic capacity domains (cognition, locomotion, vitality, sensory, and psychological), frailty phenotype (Fried criteria), and physical function.
详细描述
Frailty is a dynamic syndrome marked by diminished physiological reserves and increased vulnerability to stressors. It is prevalent among institutionalized older adults and is associated with higher risks of dependency, hospitalization, and reduced quality of life. Evidence shows that physical inactivity and sedentary behavior significantly contribute to the onset and progression of frailty, especially in long-term care settings.
The World Health Organization (WHO) introduced the concept of Intrinsic Capacity in 2015, emphasizing a multidimensional view of healthy aging that includes cognition, mobility, vitality, sensory function, and psychological well-being. Preserving or enhancing intrinsic capacity is critical to prolonging independence and life quality among older adults.
This trial assesses the effectiveness of the FEXO program, a playful multicomponent exercise intervention designed to enhance intrinsic capacity and reduce frailty in adults over 75 years of age residing in geriatric care centers of the Ballesol Group (Valencia and Alicante). The intervention combines aerobic, strength, balance, gait, and flexibility exercises delivered in a recreational and group-based format using playful tools (e.g., foam balls, scarves, bubbles). Participants will engage in three 55-60 minute sessions per week over 14 weeks.
The study follows a wait-list controlled randomized design. Participants will be randomized to one of two groups: (1) the experimental group, which receives the FEXO intervention immediately, and (2) the control group, which continues routine activities during the first 14 weeks, followed by delayed participation in the program. Outcomes will be measured at baseline (T0), post-intervention (T1, at 14 weeks), and follow-up (T2, 28 weeks post-baseline for the control group).
Primary and secondary outcomes include: Fried's Frailty Phenotype, Short Physical Performance Battery (SPPB), Timed Up and Go Test (TUG), grip strength (JAMAR), walking speed (10-MWT), cognitive status (MMSE), nutritional status (MNA), depressive symptoms (GDS, CSDD), balance (Berg Balance Scale), and quality of life indicators.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥75 years.
- •Resident in a long-term care facility (residencia geriátrica) affiliated with the Ballesol group (Levante area: Valencia and Alicante).
- •Provide informed consent (or consent by legal representative, if appropriate).
- •Functional and/or cognitive status that allows them to participate in basic physical activity and understand and follow basic verbal instructions.
排除标准
- •Unstable medical condition or uncontrolled chronic disease.
- •Severe cognitive impairment or advanced dementia that prevents comprehension or adherence to the intervention, determined by clinical assessment or MMSE <
- •Severe physical disability.
- •Active infectious disease or acute condition requiring isolation or rest.
- •Participation in another structured physical activity or rehabilitation program during the study period.
- •End-of-life situation or terminal illness.
- •Any condition that, in the judgment of the research or clinical team, would interfere with participation or data collection.
研究组 & 干预措施
Wait-List Control Group
Participants in this group will continue their usual daily activities for 14 weeks without receiving the FEXO intervention. After this period, they will be offered the same 14-week FEXO program as the experimental group, following the same structure, supervision, and exercise content.
FEXO Multicomponent Playful Exercise
Participants in this group will follow the FEXO program, a 14-week multicomponent playful-recreational exercise intervention. The program includes 3 supervised sessions per week (55-60 minutes each) and incorporates aerobic, resistance, balance, flexibility, and gait exercises delivered in a playful group-based format using motivational materials. The 14-week program is structured into an initial 2-week familiarization phase followed by three progressive 4-week levels. Exercises are adapted and progressively intensified according to individual capacity.
干预措施: FEXO (Fun Exercise for Older Adults) (Other)
结局指标
主要结局
Intrinsic Capacity (IC)
时间窗: Before and inmediately after the intervention
This composite outcome evaluates changes in intrinsic capacity, following the five-domain model proposed by the World Health Organization: cognition, vitality, locomotion (function), sensory function, and psychological well-being. Each domain is assessed through one standardized test: the Mini-Mental State Examination (MMSE) for cognition, the Mini Nutritional Assessment (MNA) for vitality, the Short Physical Performance Battery (SPPB) for locomotion, self-reported vision and hearing for sensory function, and the Cornell Scale for Depression in Dementia (CSDD) for psychological well-being. Each test contributes up to a maximum of 2 points, according to predefined cut-off values. For the cognitive domain (MMSE), 2 points are assigned if ≥27, 1 point if 10-26, and 0 points if 0-9. For vitality (MNA), 2 points are assigned if 24-30, 1 point if 17-23, and 0 points if \<17. For locomotion (SPPB), 2 points are assigned if ≥10, 1 point if 3-9, and 0 points if 0-2. For sensory function (self-r
Frailty (Fried's Phenotype)
时间窗: Before and inmediately after the intervention
Frailty status will be assessed using Fried's phenotype, which classifies participants as robust (0 criteria), pre-frail (1-2 criteria), or frail (3-5 criteria) based on five components: unintentional weight loss, exhaustion, low physical activity, slow gait speed, and weak grip strength. Improvement is defined as transition to a lower frailty category (e.g., from frail to pre-frail).
次要结局
- Geriatric Depression Scale (GDS)(Before and inmediately after the intervention)
- Berg Balance Scale (BBS)(Before and inmediately after the intervention)
- 10-Meter Walk Test (10-MWT)(Before and inmediately after the intervention)
- Mini-Mental State Examination (MMSE)(Before and inmediately after the intervention)
- Mini Nutritional Assessment (MNA)(Before and inmediately after the intervention)
- Self-reported Vision(Before and inmediately after the intervention)
- Barthel Index(Before and inmediately after the intervention)
- Self-reported Hearing(Before and inmediately after the intervention)
- Short Physical Performance Battery (SPPB)(Before and inmediately after the intervention)
- Timed Up and Go Test (TUG)(Before and inmediately after the intervention)
- Grip Strength (JAMAR Dynamometer)(Before and inmediately after the intervention)
- Cornell Scale for Depression in Dementia(Before and inmediately after the intervention)
研究者
Juan F. Lisón Párraga, Dr
Professor
Cardenal Herrera University