Clinical trial NCT05725668: A Study of Dual-task Exercise Training to Prevent Falls Among Older Adults With Mild Cognitive Impairment
Official title: Dual-Task Training Exercise to Reduce Falls in Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Accidental Falls
Aging
Keywords: Falls
Exercise
Dual tasking
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 336
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the efficacy of a dual-task tai ji quan training therapy in reducing the incidence of falls in older adults with mild cognitive impairment.

Detailed description: The primary aim of the study is to determine the comparative efficacy of two tai ji quan interventions (Dual-task tai ji quan, standard tai ji quan), relative to a stretching exercise control, in reducing the incidence of falls among community-dwelling older adults with mild cognitive impairment.

Eligibility criteria: Inclusion Criteria:

* being 65 years and older
* having complaint of memory loss
* scoring ≤0.5 on Clinical Dementia Scale
* having had 1 or more falls in the preceding 12 months or scoring ≥12 seconds on the Timed Up and Go test

Exclusion Criteria:

* scoring \<24 on the Mini-Mental State Examination
* being able to ambulate independently for household distances
* having medical clearance
* having participated in any regular and structured tai ji quan-based exercise programs (≥2 times weekly) in the preceding 6 months
* having a progressive neuromuscular disorder such as Parkinson's disease or multiple sclerosis
* being unwilling to be randomized

Primary outcomes:
measure: Self-reported number of falls
timeFrame: Monthly, baseline to 6 months (i.e., after end of intervention)
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Timed Up and Go (TUG)
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Dual-task walking
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: 30-second chair stand
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Trail Making (A, B)
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Category Fluency
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Forward Digit Span
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Backward Digit Span
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Proportion of fallers
timeFrame: At 6 months
Other outcomes:
measure: Activity-specific Balance Confidence
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Geriatric Depression Scale
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: EuroQol EQ-5D
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: Frailty Questionnaire
timeFrame: Baseline, 4 months, 6 months, 12 months
measure: International Physical Activity Questionnaire
timeFrame: Baseline, 4 months, 6 months, 12 months
Locations:
city: Springfield
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
References: