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Active, Not Recruiting

NCT Number: NCT07199790

Action Observation and Exercise for Balance in Older Adults: A Randomized Trial.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultat de Medicina i Ciències de la Salut

Reus, Tarragona, 43203, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Action observation videos

Other

The participant will see videos of balance exercises performed by the assigned reference, depending on their group, without performing any physical movement.

Therapeutic exercise

Other

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.

Primary outcomes

  1. Static balance

    Time frame: 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.

  2. Dynamic balance

    Time frame: 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 outcomes

  1. Trunk and lower extremity muscle strength

    Time frame: 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.

  2. Satisfaction assessed by a selfcreate questionnaire

    Time frame: 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.

  3. Grip strength

    Time frame: 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.

  4. Safety and fear of falling

    Time frame: 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).

  5. Adherence

    Time frame: 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.

  6. Incidence of falls

    Time frame: 12 weeks

    Fall events will be recorded through self-reporting during the entire intervention and follow-up period.

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Registry information

Official study title

Effect of Action Observation Combined With Therapeutic Exercise on Balance and Falls in Community-Dwelling Adults ≥65: A Randomized Trial

Acronym: AOBAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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