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Not yet recruitingNCT07762235Updated Aug 13, 2026

High-Amplitude Functional Exercises in Older Adults With Mild Cognitive Impairment

An interventional study of Dual-Task-Based High-Amplitude Functional Exercise Program and Traditional Balance and Mobility Exercise Group in Mild Cognitive Impairment (MCI) and Exercises, sponsored by Istinye University. Not yet recruiting. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Istinye University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Mild Cognitive Impairment (MCI)
  • Exercises

Keywords

  • Mild Cognitive Impairment
  • Older Adults
  • High-Amplitude Functional Exercises
  • Dual-Task Training
  • Functional Mobility
  • Dual-Task Cost
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 36 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Istinye University is the lead sponsor of 221 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Living independently/actively in a nursing home.
  • Diagnosis of Mild Cognitive Impairment (MCI) based on a standardized screening test, with a (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.

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of dementia or severe cognitive impairment based on cognitive screening ( \<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 ( 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Dual-Task-Based High-Amplitude Functional Exercise

    Other: Dual-Task-Based High-Amplitude Functional Exercise Program

  • Active comparator
    Traditional Balance and Mobility Exercise

    Other: Traditional Balance and Mobility Exercise Group

Interventions

  • OtherDual-Task-Based High-Amplitude Functional Exercise Program

    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.

  • OtherTraditional Balance and Mobility Exercise Group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to post-intervention (4 weeks)

  2. 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.

    Time frame: Baseline to post-intervention (4 weeks)

  3. 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.

    Time frame: Baseline to post-intervention (4 weeks)

Secondary outcomes

  1. Timed Up and Go Test (TUG)

    The TUG will be used to assess functional mobility and dynamic balance.

    Time frame: Baseline to post-intervention (4 weeks)

  2. Edinburgh Visual Gait Score

    The EVGS will be used to assess gait quality through observational analysis of gait kinematics across different anatomical segments.

    Time frame: Baseline to post-intervention (4 weeks)

  3. 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.

    Time frame: Baseline to post-intervention (4 weeks)

  4. Dual-Task Cost

    Dual-task cost will be calculated from the TUG performance using the formula.

    Time frame: Baseline to post-intervention (4 weeks)

  5. 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.

    Time frame: Baseline to post-intervention (4 weeks)

  6. 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.

    Time frame: Baseline to post-intervention (4 weeks)

  7. 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).

    Time frame: Post-intervention (4 weeks)

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Apr 2027, 7 months later.

Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 7 months is below that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2026
First posted
Aug 13, 2026
StartEst.
Aug 20, 2026
Primary completionEst.
Apr 5, 2027
CompletionEst.
Apr 5, 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07762235
Lead sponsor
Istinye University
Responsible party
Yunus Emre Tutuneken (Dr. Assistant Professor, Istinye University) — Principal investigator
First posted
Aug 13, 2026
Start date
Aug 20, 2026 (estimated)
Primary completion
Apr 5, 2027 (estimated)
Completion
Apr 5, 2027 (estimated)
Last update
Aug 13, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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