Cognitive FunctionNCT07418970
Effects of Action Observation Therapy in Geriatric Individuals
A study testing Action and Action Observation Therapy in people with Cognitive Function and Balance Impairment, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to investigate the effects of Action Observation Therapy (AOT) on cognitive function, balance, fatigue, and functional capacity in geriatric individuals. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Balance Impairment, Fatigue
- What is being tested?
- Action and Action Observation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Action Observation Therapy on Cognitive Function, Balance, Fatigue, and Functional Capacity in Geriatric Individuals: A Randomized Controlled Trial
This randomized controlled trial aimed to investigate the effects of Action Observation Therapy (AOT) on cognitive function, balance, fatigue, and functional capacity in geriatric individuals. Participants aged 65 years and older were randomly assigned to one of three groups: a control group, an exercise group, or an action observation therapy group. The intervention period lasted 8 weeks. The exercise group received a conventional exercise program, while the action observation therapy group watched exercise videos before performing the same exercises. The control group did not participate in any structured exercise program during the study period. Outcome measures included cognitive function, balance performance, fatigue levels, and functional capacity. The study evaluated whether adding action observation therapy to conventional exercise provides additional benefits in older adults.
Read the 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.
- Conditions
- Cognitive Function, Balance Impairment, Fatigue, Aging
- Being tested
- Action, Action Observation Therapy
- Keywords
- Action Observation Therapy, Balance, Exercise therapy, Functional capacity
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActionOther
exercise
Action Observation TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Action Observation Therapy | Experimental | 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 Receives: Other: Action Observation Therapy |
| Exercise | Active comparator | Warm-up Exercises: Active joint range of motion and sequential circumduction of the shoulder forwards and backwards,
* Weight transfer to the hips in a seated position,
* Isometric contraction exercises for the lower extremity extensor, flexor, adductor, and abductor groups in a seated position (performed using a towel or thin pillow),
* Bridge pose,
* Hip abduction in a side-lying position,
* Knee and shoulder flexion and extension,
* Supine position trunk flexion,
* Weight transfer to lower extremities while standing,
* Semi squat,
* Walking,
* Cool-down Exercises: Performed as stretching and breathing exercises for the hamstrings, quadriceps femoris, and pectoral muscles.
The exercises consisted of these movements. Receives: Other: Action |
| Control Group | No intervention | No action was taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
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
Measured: Baseline and 8 weeks
Dynamic balance performance
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
Measured: Baseline and 8 weeks
Static balance performance
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
Measured: Baseline and 8 weeks
Fatigue Level Assement
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
Measured: Baseline and 8 weeks
Cognitive function
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jan 2025
- Primary completion1 Oct 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of three parallel groups: a control group, an exercise group, or an action observation therapy group. Each group received its assigned intervention throughout the 8-week study period without crossover between groups.
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker DEMİR, Hasan Kalyoncu University
- Investigators
- Ilker Demir, PhD, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418970
- Sponsor's protocol ID
- 2024/169
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
No publications are currently available for this study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Action Observation Therapy on Cognitive Function, Balance, Fatigue, and Functional Capacity in Geriatric Individuals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07418970
- Acronym / sponsor ID
- 2024/169
- Conditions
- Cognitive Function, Balance Impairment, Fatigue, Aging
- Keywords
- Action Observation Therapy, Balance, Exercise therapy, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aimed to investigate the effects of Action Observation Therapy (AOT) on cognitive function, balance, fatigue, and functional capacity in geriatric individuals. Participants aged 65 years and older were randomly assigned to one of three groups: a control group, an exercise group, or an action observation therapy group. The intervention period lasted 8 weeks. The exercise group received a conventional exercise program, while the action observation therapy group watched exercise videos before performing the same exercises. The control group did not participate in any structured exercise program during the study period. Outcome measures included cognitive function, balance performance, fatigue levels, and functional capacity. The study evaluated whether adding action observation therapy to conventional exercise provides additional benefits in older adults.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel groups: a control group, an exercise group, or an action observation therapy group. Each group received its assigned intervention throughout the 8-week study period without crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Action Observation Therapy | Experimental | Other: Action Observation TherapyBased 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 |
| Exercise | Active comparator | Other: ActionWarm-up Exercises: Active joint range of motion and sequential circumduction of the shoulder forwards and backwards, * Weight transfer to the hips in a seated position, * Isometric contraction exercises for the lower extremity extensor, flexor, adductor, and abductor groups in a seated position (performed using a towel or thin pillow), * Bridge pose, * Hip abduction in a side-lying position, * Knee and shoulder flexion and extension, * Supine position trunk flexion, * Weight transfer to lower extremities while standing, * Semi squat, * Walking, * Cool-down Exercises: Performed as stretching and breathing exercises for the hamstrings, quadriceps femoris, and pectoral muscles. The exercises consisted of these movements. |
| Control Group | No intervention | –No action was taken. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actionexercise | Other | Exercise |
| Action Observation TherapyBased 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 | Other | Action Observation Therapy |
Primary outcome
Functional capacity
Time frame: Baseline and 8 weeks
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
Dynamic balance performance
Time frame: Baseline and 8 weeks
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
Static balance performance
Time frame: Baseline and 8 weeks
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
Fatigue Level Assement
Time frame: Baseline and 8 weeks
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
Cognitive function
Time frame: Baseline and 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- BackgroundNo publications are currently available for this study.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker Demir, PhD principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action and Action Observation Therapy in people with Cognitive Function and Balance Impairment, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: Baseline and 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07418970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.