Design, Development, and Validation of a Recreational Exercise Intervention in Older Adults to Improve Intrinsic Capacity and Motivation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Intrinsic Capacity
研究概览
简要总结
This randomized clinical trial aims to evaluate the effectiveness of a structured, multicomponent recreational exercise program (FEXO: Fun Exercise for Older Adults) in improving intrinsic capacity, motivation, and adherence among community-dwelling older adults. Participants aged 60 years and older will be randomly allocated to either the FEXO group or a control group performing the established OTAGO program. The intervention will last 14 weeks, with three weekly sessions. Assessments will be conducted at baseline, post-intervention, and after a 3-month follow-up.
详细描述
The global increase in the aging population poses significant public health and societal challenges, particularly regarding multimorbidity, frailty, and functional decline. In response, the World Health Organization has introduced the concept of Intrinsic Capacity (IC), which encompasses the physical and mental capacities an individual can draw upon. IC includes five domains: locomotion, vitality, cognition, psychological well-being, and sensory function.
Evidence supports multicomponent exercise as a primary strategy to promote healthy aging and preserve functionality in older adults. However, low adherence and motivation remain critical barriers. This study proposes a novel, recreationally oriented multicomponent program-FEXO-designed to increase engagement through fun, low-cost, group-based sessions adapted to functional levels.
The study is a two-arm, parallel-group, randomized clinical trial with a 2:1 allocation ratio (intervention:control). A total of 122 older adults from the community will be recruited and randomized into either the FEXO group or the control group (OTAGO program). Both interventions include three non-consecutive weekly sessions over 14 weeks. The FEXO program includes a familiarization phase and progressive intensity adjustments.
Sessions integrate strength, balance, coordination, cognitive stimulation, and relaxation in a recreational format using music, elastic bands, and playful materials. Primary outcomes include changes in Intrinsic Capacity, assessed through standardized tools across its five domains. Secondary outcomes include anthropometric data, cardiovascular parameters, physical performance tests, cognitive function, depression, resilience, and exercise motivation. Adherence will be tracked as the percentage of sessions attended.
Statistical analysis will be conducted on an intention-to-treat basis using two-way ANOVA, with effect sizes and confidence intervals reported. The study has been approved by the Ethics Committee of CEU Cardenal Herrera University and complies with the Declaration of Helsinki.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling adults aged 60 years or older.
- •Able to walk independently, with or without assistive devices (e.g., cane or walker).
- •Provide written informed consent before participation.
- •Willing and able to attend scheduled exercise sessions and assessments over the full duration of the study.
排除标准
- •Presence of severe psychiatric or psychological disorders that may interfere with participation or adherence.
- •Physical incapacity to perform moderate-intensity exercise safely.
- •Participation in another structured multicomponent exercise program during the intervention period.
- •Cognitive impairment that limits comprehension or execution of instructions, as determined by clinical evaluation.
- •Recent fractures, or uncontrolled cardiovascular conditions that contraindicate exercise.
- •Any medical condition judged by the investigators to contraindicate physical exercise or to pose an unacceptable risk.
研究组 & 干预措施
FEXO (Fun EXercise for Older adults)
Participants assigned to the experimental group will take part in a structured multicomponent exercise program specifically designed for older adults. The program, named FEXO, emphasizes recreational and motivational aspects to enhance adherence and enjoyment. It consists of three non-consecutive 1-hour sessions per week for 14 weeks. Exercises are conducted in a group setting (maximum ratio 1 instructor to 15 participants) and are progressively adapted according to the functional capacity of each participant, assessed using the Short Physical Performance Battery (SPPB).
The program uses simple, low-cost, portable materials such as elastic bands, chairs, soft balls, scarves, maracas, and a bubble machine, creating a playful and inclusive environment.
干预措施: Fun Exercise for Older Adults (FEXO) (Other)
OTAGO multicomponent exercise program
Participants in the control group will follow the OTAGO Exercise Program, a widely studied and evidence-based intervention aimed at reducing fall risk and improving lower-limb strength and balance in older adults. This program also lasts 14 weeks, with three non-consecutive sessions per week, delivered in a group format under the supervision of a physiotherapist.
Unlike the FEXO program, OTAGO is more traditional and does not include recreational or cognitive stimulation elements. It serves as an active comparator to evaluate whether incorporating fun and motivational strategies improves adherence, engagement, and intrinsic capacity.
干预措施: OTAGO (Other)
结局指标
主要结局
Intrinsic Capacity
时间窗: Before and inmediately after the intervention
It is a multidimensional concept defined by the World Health Organization to represent the total physical and mental capacities of an individual. It includes five domains: locomotion (SPPB), vitality (MDA), cognition (MMSE), psychological well-being (CSDD), and sensory function (Self-reported). Each domain contributes up to 2 points, for a total composite score ranging from 0 to 10. Higher scores indicate better intrinsic capacity and functional reserve. The specific instruments used to assess each domain are standard, validated tools, and although they contribute to the IC score, they will also be analyzed separately as secondary outcomes to better understand changes in each specific domain.
Adherence to intervention
时间窗: During intervention
Adherence will be calculated as the percentage of sessions attended out of the total planned (42 sessions over 14 weeks). Higher adherence rates reflect better feasibility and acceptance of the exercise program.
Motivation (Behavioral Regulation in Exercise Questionnaire (BREQ-3))
时间窗: Before and inmediately after the intervention
This self-report questionnaire assesses different types of motivation toward exercise (intrinsic, identified, introjected, external, and amotivation) based on Self-Determination Theory. Each subscale ranges from 0 to 12 points. Higher scores in intrinsic and identified motivation are considered positive indicators of adherence and engagement, whereas higher scores in introjected, external, and amotivation reflect lower quality motivation and are considered unfavorable.
次要结局
- Frailty status (Fried criteria)(Before and inmediately after the intervention)
- Grip Strenght (JAMAR Dynamometer)(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)
- Geriatric Depression Scale (GDS)(Before and inmediately after the intervention)
- Berg Balance Scale (BBS)(Before and inmediately after the intervention)
- Sit-to-Stand Test (STS-5)(Before and inmediately after the intervention)
- Timed Up and Go (TUG) - Standard version(Before and inmediately after the intervention)
- Trail Making Test - Part A(Before and inmediately after the intervention)
- Montreal Cognitive Assessment (MoCA)(Before and inmediately after the intervention)
- Physical Resilience Instrument for Older Adults (PRIFOR)(Before and inmediately after the intervention)
- Timed Up and Go with Manual Task (TUG-M)(Before and inmediately after the intervention)
- Timed Up and Go with Cognitive Task (TUG-C)(Before and inmediately after the intervention)
- Cornell Scale for Depression un Dementia (CSDD)(Before and inmediately after the intervention)
- Self-reported Vision(Before and inmediately after the intervention)
- Self-reported Hearing(Before and inmediately after the intervention)
- Blood pressure(Before and inmediately after the intervention)
- Heart rate(Before and inmediately after the intervention)
研究者
Juan F. Lisón Párraga, Dr
Professor
Cardenal Herrera University