High-Amplitude Functional Exercises in Older Adults With Mild Cognitive Impairment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorIstinye University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dual-Task-Based High-Amplitude Functional Exercise Program
Other interventionParticipants 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 interventionParticipants 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Dual-Task-Based High-Amplitude Functional ExerciseExperimental treatment 1 intervention
Group B: Traditional Balance and Mobility ExerciseActive comparator 1 intervention
Trial outcomes
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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