- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418970
Effects of Action Observation Therapy in Geriatric Individuals
Investigating the Effects of Action Observation Therapy on Cognitive Function, Balance, Fatigue, and Functional Capacity in Geriatric Individuals: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a three-arm randomized controlled trial designed to evaluate the effects of Action Observation Therapy (AOT) on cognitive function, balance, fatigue, and functional capacity in geriatric individuals aged 65 years and older.
Participants were randomly assigned to one of three groups: (1) a control group that did not receive any structured exercise intervention during the study period, (2) an exercise group that participated in a conventional exercise program, and (3) an action observation therapy group that watched exercise demonstration videos prior to performing the same conventional exercise program.
The intervention period lasted 8 weeks. The conventional exercise program included balance, strengthening, and functional mobility exercises appropriate for older adults. The action observation therapy group observed standardized exercise videos to facilitate motor learning before actively performing the exercises.
Primary and secondary outcome measures included cognitive function (e.g., Montreal Cognitive Assessment), balance performance (e.g., Timed Up and Go Test and One-Leg Stand Test), fatigue levels (e.g., Fatigue Severity Scale), and functional capacity (e.g., 6-Minute Walk Test). Assessments were performed at baseline and at the end of the 8-week intervention period.
The primary objective of the study was to determine whether adding action observation therapy to conventional exercise provides additional benefits in cognitive and functional outcomes in geriatric individuals.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye), 4400
- Inonu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 years and older
- Community-dwelling older adults
- Able to ambulate independently with or without an assistive device
- Able to understand and follow verbal instructions
- Provided written informed consent
Exclusion Criteria:
- Severe neurological, vestibular, or orthopedic conditions affecting balance or mobility
- Severe visual or hearing impairment interfering with participation
- Diagnosed psychiatric disorders affecting cognitive assessment
- Participation in another structured exercise program during the study period
- Any medical condition contraindicating exercise participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
No action was taken.
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Experimental: Action Observation Therapy
Based on exercise recommendations for older adults from the American College of Sports Medicine (ACSM), the researcher developed a conventional exercise training programme suitable for participants aged 65 and over, incorporating balance, strength and flexibility exercises. In parallel, an action observation therapy exercise video recording was prepared for the experimental group participants. The exercises were easy to learn, not complex in terms of memory and performance, performed standing up without sitting down, and progressed from easy to difficult. The exercise programme was carried out for a total of 16 sessions over four weeks, with 8 repetitions per set for the first four weeks and 12 repetitions per set for the next four weeks, for 30-45 minutes, twice a week. Participants in the control group were informed that they would be enrolled in their preferred exercise programme afterwards, and no exercise programme was implemented throughout the study. The same exercise progra |
Based on exercise recommendations for older adults from the American College of Sports Medicine (ACSM), the researcher developed a conventional exercise training programme suitable for participants aged 65 and over, incorporating balance, strength and flexibility exercises. In parallel, an action observation therapy exercise video recording was prepared for the experimental group participants. The exercises were easy to learn, not complex in terms of memory and performance, performed standing up without sitting down, and progressed from easy to difficult. The exercise programme was carried out for a total of 16 sessions over four weeks, with 8 repetitions per set for the first four weeks and 12 repetitions per set for the next four weeks, for 30-45 minutes, twice a week. Participants in the control group were informed that they would be enrolled in their preferred exercise programme afterwards, and no exercise programme was implemented throughout the study. The same exercise program |
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Active Comparator: Exercise
Warm-up Exercises: Active joint range of motion and sequential circumduction of the shoulder forwards and backwards,
The exercises consisted of these movements. |
exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional capacity
Time Frame: Baseline and 8 weeks
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To determine functional capacity, the 6-Minute Walk Test (6MWT) was administered in accordance with the American Thoracic Society protocol.
During the test, patients were expected to complete the test by walking as fast as possible on a 30-metre straight corridor without running.
Before starting, individuals were informed about the test and verbally advised that they could slow down, rest, and terminate the test if they felt tired or short of breath.
The 6MWT test was interpreted according to gender using the following formulas
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Baseline and 8 weeks
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Dynamic balance performance
Time Frame: Baseline and 8 weeks
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During the test, the time it took for the patient to get up from the chair they were sitting in, walk a distance of 3 meters, then return to the starting position was measured
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Baseline and 8 weeks
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Static balance performance
Time Frame: Baseline and 8 weeks
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The test was performed to measure static standing capacity.
The time was started when the person lifted their foot and stopped when the lifted foot touched the ground, the supporting foot bounced, or the person had to take support to maintain balance.
It was performed twice with eyes open, and the average time was recorded
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Baseline and 8 weeks
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Fatigue Level Assement
Time Frame: Baseline and 8 weeks
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Fatigue severity scale was applied to evaluate the fatigue levels of the patients.
This scale consists of a total of 9 questions, and each question was scored from one to seven depending on the participants' agreement with the questions.
The scores on the scale are 1 point for strongly disagree, 3 points for tend to disagree, 4 points for undecided, 5 points for tend to agree, and 7 points for strongly agree
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Baseline and 8 weeks
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Cognitive function
Time Frame: Baseline and 8 weeks
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Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA).
The MoCA evaluates global cognitive performance including attention, memory, language, executive functions, and visuospatial abilities in older adults.
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Baseline and 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ilker Demir, PhD, Hasan Kalyoncu University
Publications and helpful links
General Publications
- No publications are currently available for this study.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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