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

NCT ID: NCT07199790

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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 104 participants will be allocated to four groups: control, 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, 4, 8, 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.

Conditions

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Balance Disorders Fall Elderly (People Aged 65 or More) Exercise Observation Physical Therapist

Keywords

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balance strength referent exercise therapy healthy aging action observation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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No Intervention: Control Group

Participants will not engage in any therapeutic exercise program or action observation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise Group

Participants will perform a therapeutic exercise program aimed at improving balance and preventing falls, three times per week for twelve weeks.

Group Type EXPERIMENTAL

Therapeutic exercise

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Action observation videos

Intervention Type 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

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Action observation videos

Intervention Type 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

Intervention Type 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.

Interventions

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Action observation videos

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

Intervention Type OTHER

Therapeutic 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Rovira i Virgili

OTHER

Sponsor Role lead

Responsible Party

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Tania López Hernández

Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Facultat de Medicina i Ciències de la Salut

Reus, Tarragona, Spain

Site Status

Countries

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Spain

Central Contacts

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Phd. Tania López Hernández

Role: CONTACT

Phone: 34+620438175

Email: [email protected]

Facility Contacts

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Tania López Hernández

Role: primary

References

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Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009. Epub 2013 Mar 22.

Reference Type BACKGROUND
PMID: 23523272 (View on PubMed)

Zhang M, Zhang T, He Y, Luo J. Comparison of motor imagery and action observation on lower limb function in older adults: a systematic review and meta-analysis. Geriatr Nurs. 2025 Sep-Oct;65:103468. doi: 10.1016/j.gerinurse.2025.103468. Epub 2025 Jul 5.

Reference Type BACKGROUND
PMID: 40618719 (View on PubMed)

Leem SH, Kim JH, Lee BH. Effects of Otago exercise combined with action observation training on balance and gait in the old people. J Exerc Rehabil. 2019 Dec 31;15(6):848-854. doi: 10.12965/jer.1938720.360. eCollection 2019 Dec.

Reference Type BACKGROUND
PMID: 31938708 (View on PubMed)

Lopez Hernandez T, Caparo Ferre M, Salas-Huetos A, Salvat Salvat I, Adillon Camon C. Influence of referent selection on balance in action observation: A randomized controlled trial. Complement Ther Med. 2025 Jun;90:103150. doi: 10.1016/j.ctim.2025.103150. Epub 2025 Feb 20.

Reference Type BACKGROUND
PMID: 39986658 (View on PubMed)

Other Identifiers

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09/2025

Identifier Type: -

Identifier Source: org_study_id