NCT07762235

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

August 20, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 9, 2026

Last Update Submit

August 9, 2026

Conditions

Keywords

Mild Cognitive ImpairmentOlder AdultsHigh-Amplitude Functional ExercisesDual-Task TrainingFunctional MobilityDual-Task Cost

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline to post-intervention (4 weeks)

Secondary Outcomes (7)

  • Timed Up and Go Test (TUG)

    Baseline to post-intervention (4 weeks)

  • Edinburgh Visual Gait Score

    Baseline to post-intervention (4 weeks)

  • Dual-Task Walking Speed

    Baseline to post-intervention (4 weeks)

  • Dual-Task Cost

    Baseline to post-intervention (4 weeks)

  • Falls Efficacy Scale-International I

    Baseline to post-intervention (4 weeks)

  • +2 more secondary outcomes

Study Arms (2)

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

Interventions

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.

Dual-Task-Based High-Amplitude Functional Exercise

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.

Traditional Balance and Mobility Exercise

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Assistant Professor

Study Record Dates

First Submitted

August 9, 2026

First Posted

August 13, 2026

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

April 5, 2027

Study Completion (Estimated)

April 5, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08