Trials / Not Yet Recruiting
Not Yet RecruitingNCT07199790
Action Observation and Exercise for Balance in Older Adults: A Randomized Trial.
Effect of Action Observation Combined With Therapeutic Exercise on Balance and Falls in Community-Dwelling Adults ≥65: A Randomized Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- University Rovira i Virgili · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| 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. |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2027-06-30
- Completion
- 2027-12-31
- First posted
- 2025-09-30
- Last updated
- 2025-09-30
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT07199790. Inclusion in this directory is not an endorsement.