Effect of Action Observation Combined With Therapeutic Exercise on Balance and Falls in Community-Dwelling Adults ≥65: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Static balance
研究概览
简要总结
The primary objective is to evaluate the effectiveness of combining action observation with a therapeutic exercise program to improve balance and prevent falls in adults aged ≥65 with low to moderate fall risk.
详细描述
Background: Action observation activates brain networks involved in motor learning and has shown benefits in neurological and musculoskeletal populations (improvement of balance, gait, and pain). However, evidence in older adults at risk of falls and the role of the observed model remain underexplored. Objectives: The primary objective is to evaluate the effectiveness of combining action observation with a therapeutic exercise program to improve balance and prevent falls in adults aged ≥65 with low to moderate fall risk. Secondary objectives include comparing efficacy according to the observed model, and analyzing effects on strength, fear of falling, adherence, and fall incidence. Methods: A single-blind, randomized clinical trial of 24 weeks (12 intervention, 12 follow-up) is planned. A total of 93 participants will be allocated to 3 groups: exercise, exercise with action observation of a standard model, and exercise with action observation of a self-selected model. The intervention (therapeutic exercise program and/or action observation of the same program) will be delivered three times per week with biweekly progressions. The primary outcome will be balance (static balance measured by sway area on force platform and dynamic balance assessed by Timed Up and Go test). Secondary outcomes will include handgrip and lower limb strength, fear of falling, adherence, and fall incidence. Assessments will be conducted at weeks 0, 6, 12, and 24. Both ITT and per-protocol analyses will be performed, with intra- and inter-group comparisons (p<0.05). Discussion: If effective, this low-cost, low-technology program could be easily scaled up in primary care and community settings, with potential impact on public health and physiotherapy. Applicability may also extend to neurorehabilitation and secondary prevention in frailty. Anticipated limitations: adherence, partial blinding, and external validity limited to community-dwelling older adults. Implications: development of concise practice guidelines, standardized audiovisual materials, and future research in clinical populations.
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)
盲法说明
The study was conducted using a single-blind design. The researchers responsible for recruitment and assessments were unaware of each participant's intervention group, which helped reduce detection bias. Data analysis will be performed by an external researcher. The principal investigator will manage the study documentation, informed consent process, and randomization.
Double blinding was not possible because the intervention involved a physical exercise program, meaning that participants were aware that they were taking part in an intervention. To minimize potential bias, study roles were clearly separated: one researcher delivered the intervention; another conducted the balance assessments; another assessed individual characteristics and strength; and another supported the recording of fall-related incidents. No information was exchanged between researchers in order to prevent data crossover.
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
- •Individuals over 65 years of age with low or moderate risk of falls as measured by the Timed Up and Go test, who have voluntarily signed the informed consent form and are willing to follow the protocol proposed by the research team.
排除标准
- •Presence of uncorrected visual impairments preventing screen observation; diagnosis of a condition that makes adherence to the protocol impossible (cognitive, oncological, psychiatric, psychological, vestibular, neurological, etc.); presence of a musculoskeletal injury at the time of selection and/or prior participation in studies involving movement representation methods.
- •Withdrawal criteria: Lack of participant compliance, defined as failure to complete at least 80% of the intervention sessions and assessments.
研究组 & 干预措施
No Intervention: Control Group
Participants will not engage in any therapeutic exercise program or action observation.
Exercise Group
Participants will perform a therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks.
干预措施: Therapeutic exercise (Other)
Standard Referent Group
Participants will perform the same therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. In addition, they will observe a standard model performing the same program, also three times per week.
干预措施: Action observation videos (Other)
Standard Referent Group
Participants will perform the same therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. In addition, they will observe a standard model performing the same program, also three times per week.
干预措施: Therapeutic exercise (Other)
Self-Selected Referent Group
Participants will perform the therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. In addition, they will observe a model they have personally selected based on perceived similarity, also three times per week, performing the same program.
干预措施: Action observation videos (Other)
Self-Selected Referent Group
Participants will perform the therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks. In addition, they will observe a model they have personally selected based on perceived similarity, also three times per week, performing the same program.
干预措施: Therapeutic exercise (Other)
结局指标
主要结局
Static balance
时间窗: 12 weeks
Center of pressure analysis: The displacement of the center of pressure (CPD) of the participants will be measured through posturographic tests performed on a force platform. The following variables related to the center of pressure (CoP) will be calculated: the roll area (in square millimeters) and the distribution of the weight load on both sides.
Dynamic balance
时间窗: 12 weeks
To assess participants' dynamic balance, the Timed Up and Go test (39-41) will be used. This test records the time, in seconds, it takes for an individual to rise from a chair, walk three meters, turn around, return, and sit down again. It is one of the most widely used tools in older adults due to its simplicity, quick administration, and high reliability. Intra- and inter-rater reliability values range from 0.94 to 0.99, and test-retest reliability from 0.95 to 0.99. Moreover, it shows significant correlations with lower-limb strength, the Berg Balance Scale, and other functional assessments.
Static balance
时间窗: 12 weeks
Center of pressure analysis: The displacement of the center of pressure (CPD) of the participants will be measured through posturographic tests performed on a force platform. The following variables related to the center of pressure (CoP) will be calculated: the roll area (in square millimeters) and the distribution of the weight load on both sides.
Dynamic balance
时间窗: 12 weeks
To assess participants' dynamic balance, the Timed Up and Go test (39-41) will be used. This test records the time, in seconds, it takes for an individual to rise from a chair, walk three meters, turn around, return, and sit down again. It is one of the most widely used tools in older adults due to its simplicity, quick administration, and high reliability. Intra- and inter-rater reliability values range from 0.94 to 0.99, and test-retest reliability from 0.95 to 0.99. Moreover, it shows significant correlations with lower-limb strength, the Berg Balance Scale, and other functional assessments.
次要结局
- Trunk and lower extremity muscle strength(12 weeks)
- Satisfaction assessed by a selfcreate questionnaire(12 weeks)
- Grip strength(12 weeks)
- Satisfaction assessed by a selfcreate questionnaire(12 weeks)
- Trunk and lower extremity muscle strength(12 weeks)
- Grip strength(12 weeks)
- Safety and fear of falling(12 weeks)
- Adherence(12 weeks)
- Incidence of falls(12 weeks)
研究者
Tania López Hernández
Phd
University Rovira i Virgili