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NCT Number: NCT07762235

High-Amplitude Functional Exercises 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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Behavior Cognition Disorders Cognitive Dysfunction Exercises Mental Disorders Motor Activity Neurocognitive Disorders

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dual-Task-Based High-Amplitude Functional Exercise Program

Other

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 Group

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Timed Up and Go Test (TUG)

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

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

  2. Edinburgh Visual Gait Score

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

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

  3. Dual-Task Walking Speed

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

    Walking speed will be measured during a cognitive dual-task condition over a 10-meter walking course and recorded in meters per second.

  4. Dual-Task Cost

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

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

  5. Falls Efficacy Scale-International I

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

    The FES-I will be used to assess concerns about falling during daily activities. Higher scores indicate greater fear of falling.

  6. Barthel Index

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

    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.

  7. Global Change Scale

    Time frame: Post-intervention (4 weeks)

    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).

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Effects of Dual-Task-Based High-Amplitude Functional Exercises on Balance and Functional Mobility in Older Adults With Mild Cognitive Impairment

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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