Mild Cognitive Impairment (MCI)NCT07762235
High-Amplitude Functional Exercises in Older Adults With Mild Cognitive Impairment
A study testing Dual-Task-Based High-Amplitude Functional Exercise Program and Traditional Balance and Mobility Exercise Group in people with Mild Cognitive Impairment (MCI) and Exercises, run by Istinye University.
Trial summary
This study will investigate the effects of dual-task-based high-amplitude functional exercises on balance and functional mobility in older adults with mild cognitive impairment. A total of 36 participants aged 65 years and older will be randomly assigned to either a high-amplitude functional exercise group or a… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Exercises
- What is being tested?
- Dual-Task-Based High-Amplitude Functional Exercise Program and Traditional Balance and Mobility Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 5 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Who may be able to join
- Living independently/actively in a nursing home.
- Diagnosis of Mild Cognitive Impairment (MCI) based on a standardized screening test, with a Montreal Cognitive Assessment (MoCA) score of 18-25.
- Ability to walk independently for at least 10 meters without an assistive device or with only a cane/single-point support.
- Sufficient vision and hearing capacity to follow dual-task instructions and exercise directions, which may be corrected with glasses or hearing aids.
- Stable medical condition that does not prevent participation in the exercise program throughout the study.
Who cannot join
- Diagnosis of dementia or severe cognitive impairment based on cognitive screening (MoCA <17).
- Neurological conditions that primarily affect balance, such as Parkinson's disease, residual effects of stroke, multiple sclerosis, or cerebellar ataxia.
- Severe osteoarthritis, active inflammatory joint disease, or a history of major orthopedic surgery within the previous 6 months that could limit exercise performance.
- Uncontrolled hypertension, heart failure (NYHA Class III-IV), or cardiopulmonary instability causing symptoms during exercise.
- Advanced vestibular pathology or severe loss of proprioception in the lower extremities that could be the primary cause of balance impairment.
About this study
Official title: Effects of Dual-Task-Based High-Amplitude Functional Exercises on Balance and Functional Mobility in Older Adults With Mild Cognitive Impairment
This study will investigate the effects of dual-task-based high-amplitude functional exercises on balance and functional mobility in older adults with mild cognitive impairment. A total of 36 participants aged 65 years and older will be randomly assigned to either a high-amplitude functional exercise group or a traditional balance and mobility exercise group. Both groups will participate in exercise sessions four times per week for four weeks, with each session lasting 60 minutes. The effects of the exercise programs will be evaluated by assessing balance, functional mobility, dual-task performance, walking performance, fear of falling, and independence in daily activities before and after the intervention.
- Conditions
- Mild Cognitive Impairment (MCI), Exercises
- Being tested
- Dual-Task-Based High-Amplitude Functional Exercise Program, Traditional Balance and Mobility Exercise Group
- Keywords
- Mild Cognitive Impairment, Older Adults, High-Amplitude Functional Exercises, Dual-Task Training, Functional Mobility, Dual-Task Cost
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task-Based High-Amplitude Functional Exercise ProgramOther
Participants will receive a dual-task-based high-amplitude functional exercise program consisting of high-amplitude functional movements combined with progressively challenging cognitive tasks. The program will be administered 4 times per week for 4 weeks, for a total of 16 sessions, with each session lasting 60 minutes. Exercise intensity will be prescribed as maximal effort, corresponding to 7-8/10 on the Borg Rating of Perceived Exertion Scale. The program will include seated and standing functional exercises, large-amplitude stepping movements, dynamic movements, large-amplitude walking, functional task activities, and complex functional tasks.
Traditional Balance and Mobility Exercise GroupOther
Participants will receive a traditional balance and mobility exercise program administered 4 times per week for 4 weeks, for a total of 16 sessions, with each session lasting 60 minutes. Exercise intensity will be moderate, corresponding to 4-5/10 on the Borg Rating of Perceived Exertion Scale. The program will consist of motor tasks without cognitive dual-task components.
| Study group | Role | What they receive |
|---|---|---|
| Dual-Task-Based High-Amplitude Functional Exercise | Experimental | Not described Receives: Other: Dual-Task-Based High-Amplitude Functional Exercise Program |
| Traditional Balance and Mobility Exercise | Active comparator | Not described Receives: Other: Traditional Balance and Mobility Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-Task Timed Up and Go Test
The Dual-Task TUG will assess functional mobility under cognitive load by adding a cognitive task to the standard Timed Up and Go test. Test performance will be recorded as the time required to complete the task.
Measured: Baseline to post-intervention (4 weeks)
Mini-BESTest
The Mini-BESTest will be used to assess balance performance across anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait. The scale consists of 14 items scored from 0 to 2, with a maximum total score of 28. Higher scores indicate better balance performance.
Measured: Baseline to post-intervention (4 weeks)
Five Times Sit-to-Stand Test
The Five Times Sit-to-Stand Test will be used to assess lower-extremity muscle strength and functional capacity. The time required to complete five full sit-to-stand repetitions will be recorded.
Measured: Baseline to post-intervention (4 weeks)
Secondary outcomes (7)
Timed Up and Go Test (TUG)
The TUG will be used to assess functional mobility and dynamic balance.
Measured: Baseline to post-intervention (4 weeks)
Edinburgh Visual Gait Score
The EVGS will be used to assess gait quality through observational analysis of gait kinematics across different anatomical segments.
Measured: Baseline to post-intervention (4 weeks)
Dual-Task Walking Speed
Walking speed will be measured during a cognitive dual-task condition over a 10-meter walking course and recorded in meters per second.
Measured: Baseline to post-intervention (4 weeks)
Dual-Task Cost
Dual-task cost will be calculated from the TUG performance using the formula.
Measured: Baseline to post-intervention (4 weeks)
Falls Efficacy Scale-International I
The FES-I will be used to assess concerns about falling during daily activities. Higher scores indicate greater fear of falling.
Measured: Baseline to post-intervention (4 weeks)
Barthel Index
The Barthel Index will be used to assess independence in basic activities of daily living, including eating, bathing, dressing, and transfers. Scores range from 0 to 100, with higher scores indicating greater independence.
Measured: Baseline to post-intervention (4 weeks)
Global Change Scale
The Global Change Scale will be used to assess participants' perceived change following the intervention. Participants will rate perceived change from -5 (much worse) to +5 (much better).
Measured: Post-intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion5 Apr 2027 (estimated)
- Study completion5 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762235
- Sponsor's protocol ID
- 104
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual-Task-Based High-Amplitude Functional Exercises on Balance and Functional Mobility in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07762235
- Acronym / sponsor ID
- 104
- Conditions
- Mild Cognitive Impairment (MCI), Exercises
- Keywords
- Mild Cognitive Impairment, Older Adults, High-Amplitude Functional Exercises, Dual-Task Training, Functional Mobility, Dual-Task Cost
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 13 Aug 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 study will investigate the effects of dual-task-based high-amplitude functional exercises on balance and functional mobility in older adults with mild cognitive impairment. A total of 36 participants aged 65 years and older will be randomly assigned to either a high-amplitude functional exercise group or a traditional balance and mobility exercise group. Both groups will participate in exercise sessions four times per week for four weeks, with each session lasting 60 minutes. The effects of the exercise programs will be evaluated by assessing balance, functional mobility, dual-task performance, walking performance, fear of falling, and independence in daily activities before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-Task-Based High-Amplitude Functional Exercise | Experimental | Other: Dual-Task-Based High-Amplitude Functional Exercise Program |
| Traditional Balance and Mobility Exercise | Active comparator | Other: Traditional Balance and Mobility Exercise Group |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Living independently/actively in a nursing home.
- Diagnosis of Mild Cognitive Impairment (MCI) based on a standardized screening test, with a Montreal Cognitive Assessment (MoCA) score of 18-25.
- Ability to walk independently for at least 10 meters without an assistive device or with only a cane/single-point support.
- Sufficient vision and hearing capacity to follow dual-task instructions and exercise directions, which may be corrected with glasses or hearing aids.
- Stable medical condition that does not prevent participation in the exercise program throughout the study.
Key exclusion criteria (5 listed)
- Diagnosis of dementia or severe cognitive impairment based on cognitive screening (MoCA <17).
- Neurological conditions that primarily affect balance, such as Parkinson's disease, residual effects of stroke, multiple sclerosis, or cerebellar ataxia.
- Severe osteoarthritis, active inflammatory joint disease, or a history of major orthopedic surgery within the previous 6 months that could limit exercise performance.
- Uncontrolled hypertension, heart failure (NYHA Class III-IV), or cardiopulmonary instability causing symptoms during exercise.
- Advanced vestibular pathology or severe loss of proprioception in the lower extremities that could be the primary cause of balance impairment.
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 |
|---|---|---|
| Dual-Task-Based High-Amplitude Functional Exercise ProgramParticipants will receive a dual-task-based high-amplitude functional exercise program consisting of high-amplitude functional movements combined with progressively challenging cognitive tasks. The program will be administered 4 times per week for 4 weeks, for a total of 16 sessions, with each session lasting 60 minutes. Exercise intensity will be prescribed as maximal effort, corresponding to 7-8/10 on the Borg Rating of Perceived Exertion Scale. The program will include seated and standing functional exercises, large-amplitude stepping movements, dynamic movements, large-amplitude walking, functional task activities, and complex functional tasks. | Other | Dual-Task-Based High-Amplitude Functional Exercise |
| Traditional Balance and Mobility Exercise GroupParticipants will receive a traditional balance and mobility exercise program administered 4 times per week for 4 weeks, for a total of 16 sessions, with each session lasting 60 minutes. Exercise intensity will be moderate, corresponding to 4-5/10 on the Borg Rating of Perceived Exertion Scale. The program will consist of motor tasks without cognitive dual-task components. | Other | Traditional Balance and Mobility Exercise |
Primary outcome
Dual-Task Timed Up and Go Test
Time frame: Baseline to post-intervention (4 weeks)
The Dual-Task TUG will assess functional mobility under cognitive load by adding a cognitive task to the standard Timed Up and Go test. Test performance will be recorded as the time required to complete the task.
Mini-BESTest
Time frame: Baseline to post-intervention (4 weeks)
The Mini-BESTest will be used to assess balance performance across anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait. The scale consists of 14 items scored from 0 to 2, with a maximum total score of 28. Higher scores indicate better balance performance.
Five Times Sit-to-Stand Test
Time frame: Baseline to post-intervention (4 weeks)
The Five Times Sit-to-Stand Test will be used to assess lower-extremity muscle strength and functional capacity. The time required to complete five full sit-to-stand repetitions will be recorded.
7 secondary outcomes
Timed Up and Go Test (TUG)
Time frame: Baseline to post-intervention (4 weeks)
Edinburgh Visual Gait Score
Time frame: Baseline to post-intervention (4 weeks)
Dual-Task Walking Speed
Time frame: Baseline to post-intervention (4 weeks)
Dual-Task Cost
Time frame: Baseline to post-intervention (4 weeks)
Falls Efficacy Scale-International I
Time frame: Baseline to post-intervention (4 weeks)
Barthel Index
Time frame: Baseline to post-intervention (4 weeks)
Global Change Scale
Time frame: Post-intervention (4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Task-Based High-Amplitude Functional Exercise Program and Traditional Balance and Mobility Exercise Group in people with Mild Cognitive Impairment (MCI) and Exercises, run by Istinye University.
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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Dual-Task Timed Up and Go Test (time frame: Baseline to post-intervention (4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.