Balance Disorders, Elderly (People Aged 65 or More), Exercise, Fall, Observation, Physical Therapist
Conditions
Keywords
balance, strength, referent, exercise therapy, healthy aging, action observation
Brief summary
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.
Detailed description
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.
Interventions
The participant will see videos of balance exercises performed by the assigned reference, depending on their group, without performing any physical movement.
OTHERTherapeutic exercise
The therapeutic exercise program aimed at improving balance and preventing falls will be carried out three times per week (Monday, Wednesday, and Friday), with each session lasting 30-45 minutes. Each session will be structured into three blocks: a warm-up of 5-10 minutes, a main block focused on balance and strength lasting 20-25 minutes, and a cool-down of 5-10 minutes.
Sponsors
University Rovira i Virgili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static balance | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trunk and lower extremity muscle strength | 12 weeks | Analogue dynamometry will be used as an evaluation method and will be recorded in Newtons (N) with the Saehan SKU SH5007 back, leg and chest dynamometer. |
| Satisfaction assessed by a selfcreate questionnaire | 12 weeks | A questionnaire specifically designed to evaluate participants' satisfaction with their experience in the study will be used once they have completed their participation. |
| Grip strength | 12 weeks | A digital dynamometer will be used as the assessment method, and results will be recorded in kilograms using the K-Grip hand dynamometer (K-Invent®, Montpellier, France) through the grip strength test. Three 3-second trials will be performed with each hand, with 30 seconds of rest between attempts, and the best result will be selected. |
| Safety and fear of falling | 12 weeks | The validated Spanish version of the Short Falls Efficacy Scale-International (Short FES-I) will be used. This scale comprises 7 items related to daily life activities, each rated on a 4-point scale: not at all concerned (1 point), somewhat concerned (2 points), fairly concerned (3 points), or very concerned (4 points). The total score ranges from 7 to 28, with higher scores indicating greater fear of falling. The Short FES-I has shown high internal consistency (Cronbach's alpha = 0.90; intraclass correlation coefficient = 0.89), good test-retest reliability (Spearman's rho = 0.76), and strong concurrent criterion validity, as evidenced by its high correlation with the original FES-I (Spearman's rho = 0.90). |
| Adherence | 12 weeks | Adherence will be evaluated by calculating the ratio between the number of sessions completed and the total number of sessions scheduled. Recording will be carried out using a weekly log sheet filled out by participants and supervised by the research team. |
| Incidence of falls | 12 weeks | Fall events will be recorded through self-reporting during the entire intervention and follow-up period. |
Countries
Spain
Outcome results
None listed