NCT07199790

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

September 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

September 22, 2025

Last Update Submit

April 27, 2026

Conditions

Balance DisordersFallElderly (People Aged 65 or More)ExerciseObservationPhysical Therapist

Keywords

balancestrengthreferentexercise therapyhealthy agingaction observation

Outcome Measures

Primary Outcomes (2)

  • Static balance

    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.

    12 weeks

  • Dynamic balance

    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.

    12 weeks

Secondary Outcomes (6)

  • Trunk and lower extremity muscle strength

    12 weeks

  • Satisfaction assessed by a selfcreate questionnaire

    12 weeks

  • Grip strength

    12 weeks

  • Safety and fear of falling

    12 weeks

  • Adherence

    12 weeks

  • +1 more secondary outcomes

Study Arms (4)

No Intervention: Control Group

NO INTERVENTION

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

Exercise Group

EXPERIMENTAL

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

Other: Therapeutic exercise

Standard Referent Group

EXPERIMENTAL

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.

Other: Action observation videosOther: Therapeutic exercise

Self-Selected Referent Group

EXPERIMENTAL

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.

Other: Action observation videosOther: Therapeutic exercise

Interventions

Action observation videosOTHER

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

Self-Selected Referent GroupStandard Referent Group
Therapeutic exerciseOTHER

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.

Exercise GroupSelf-Selected Referent GroupStandard Referent Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultat de Medicina i Ciències de la Salut

Reus, Tarragona, 43203, Spain

Location

Related Publications (4)

  • 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.

    PMID: 23523272BACKGROUND

  • 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.

    PMID: 40618719BACKGROUND

  • 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.

    PMID: 31938708BACKGROUND

  • 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.

    PMID: 39986658BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

September 22, 2025

First Posted

September 30, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)