Effectiveness of an Innovative Therapeutic Exercise Program on Physical and Cognitive Function in Mild Cognitive Impairment Due to Alzheimer's Disease
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Patras
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Kinematic and kinetic gait assessment
Overview
Brief Summary
The goal of this randomised clinical trial is to investigate the effectiveness of an innovative therapeutic exercise program emphasizing in dual-task exercises in people with amnestic Mild Cognitive Impairment. The main questions it aims to answer are:
Does the innovative therapeutic exercise program improve gait and balance? Does the innovative therapeutic exercise program improve cognition?
Researchers will compare the innovative therapeutic exercise program emphasizing in dual-task exercises to a therapeutic exercise program without emphasizing in dual-task exercises and to a control group (given instruction about the benefits of exercise).
Participants will:
- Perform the exercise program twice a week for three months.
- Will be assessed before and after the intervention.
- Will record The Borg Scale of Perceived Exertion every second week to monitor and assess the progression of exercise intensity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •individuals \> 50 years old
- •people with confirmed cognitive impairment, as evidenced by values within normal limits on the Montreal Cognitive Assessment test (MOCA ) \>20
- •stable medication in the last month
- •independent walking
Exclusion Criteria
- •people with dementia
- •people suffering from chronic mental illness (e.g. schizophrenia, bipolar disorder)
- •people suffering from a neurological disorder or injuries (e.g. multiple sclerosis, Parkinson's, traumatic brain injury)
- •people with clinical depression (as determined by the Neuropsychiatric Inventory (NPI) assessment and medical diagnosis)
- •people who have had recent surgery
- •people with insufficient knowledge of the Greek language
Arms & Interventions
Innovative therapeutic exercise program emphasizing in dual tasking
Participants will perform aerobic exercises, strengthening exercises and balance exercises combined with cognitive exercises at the same time for 60- 90 minutes/ twice a week/ three months.
Intervention: Innovative therapeutic exercise program (Other)
Therapeutic exercise program
Participants will perform aerobic exercises, strengthening exercises and balance exercises for 60- 90 minutes/ twice a week/ three months.
Intervention: Therapeutic exercise program (Other)
Control group
The control group will be provided with educational material in the form of a flyer outlining the health benefits of exercise and general lifestyle recommendations.
Intervention: Flyer (Other)
Outcomes
Primary Outcomes
Kinematic and kinetic gait assessment
Time Frame: baseline, post- intervention (12 weeks)
Participants will be instructed to walk at their self-selected, comfortable walking pace. Gait performance will be assessed under four task conditions: single-task walking, dual-task walking, single-task obstacle crossing, and dual-task obstacle crossing. These conditions are designed to evaluate participants' walking ability and adaptability under both simple and cognitively demanding circumstances. Duration: ≈ 40 minutes
Functional Gait Assessment (FGA)
Time Frame: baseline, post- intervention (12 weeks)
The Functional Gait Assessment is a clinical tool used to evaluate postural stability during various walking tasks. The assessment includes 10 standardized walking tasks, each addressing a distinct aspect of gait and balance. Performance on each task is rated on a 4-point ordinal scale (0-3), where higher scores indicate better functional performance. The total score ranges from 0 to 30, with a higher total score representing normal gait and balance, and a lower score indicating gait instability or impaired functional mobility. Test duration: ≈ 10-15 minutes
mini Balance Evaluation Systems Test (mini-BESTest)
Time Frame: baseline, post- intervention (12 weeks)
The Mini-BESTest is a clinical balance assessment tool designed to evaluate dynamic balance control and identify the specific balance systems affected in individuals with balance disorders. It is a shortened version of the original Balance Evaluation Systems Test (BESTest). It comprises 14 items, each scored on a 3-point ordinal scale (0-2), with a maximum total score of 28 points. The assessment includes four subscales, each representing a specific component of balance control: Anticipatory Postural Adjustments - maximum score: 6 points Reactive Postural Control - maximum score: 6 points Sensory Orientation - maximum score: 6 points Dynamic Gait - maximum score: 10 points Higher scores indicate better balance performance, while lower scores reflect greater balance impairment. Test duration: ≈ 15minutes
Montreal Cognitive Assessment (MoCA)
Time Frame: baseline, post- intervention (12 weeks)
The MoCA assesses global cognitive function across multiple domains. It includes 12 brief tasks, grouped into 7 cognitive domains: Total possible score: 30 points. Each task contributes a set number of points according to its complexity. If the individual has ≤ 12 years of education, 1 additional point is added to the total score to account for educational effects. Higher score indicates better global cognition while lower scores indicate impairment Administration time: ≈ 10-15 minutes
Cognitive Telephone Screening Instrument (COGTEL)
Time Frame: baseline, post- intervention (12 weeks)
The test consists of six subtests, each targeting a specific cognitive domain: 1. Prospective Memory:(Score range: 0-2 points) 2. Verbal Short-Term Memory: (Score range: 0-8 points) 3. Verbal Long-Term Memory : (Score range: 0-8 points) 4. Working Memory (Backward Digit Span): (Score range: 0-12 points) 5. Verbal Fluency: (Score = number of correct words produced) 6. Inductive Reasoning: (Score range: 0-8 points) Each subtest yields an individual score, which are combined into a total composite score using a weighted formula reflecting the relative contribution of each domain to overall cognition: Total COGTEL score =(7.2 × Prospective Memory) + (1.0 × Verbal Short-Term Memory) + (0.9 × Verbal Long-Term Memory) + (0.8 × Working Memory) + (0.2 × Verbal Fluency) + (1.7 × Inductive Reasoning) Higher score indicates better cognitive performance while lower scores indicate impairment Administration time: ≈ 10-15 minutes
Stroop Test
Time Frame: baseline, post- intervention (12 weeks)
The Stroop test is a sensitive index of executive function and attention. During the task, the participant is required to name the color of the ink in which a word is printed rather than read the word itself. Total number of correct responses within a set time limit (60 seconds), and number of errors (including self-corrections and uncorrected errors) are calculated. Higher scores indicate better executive control, while lower or negative scores suggest difficulty inhibiting automatic responses. Administration time: ≈5-10 minutes
Secondary Outcomes
- Lipid profile(baseline, post- intervention (12 weeks))
- Hand grip strength test(baseline, post- intervention (12 weeks))
- 30 Second Sit to Stand Test(baseline, post- intervention (12 weeks))
- Falls Efficacy Scale - International (FES-I)(baseline, post- intervention (12 weeks))
- 6 Minute Walk Test (6MWT)(baseline, post- intervention (12 weeks))
- Timed Up and Go test (TUG)(baseline, post- intervention (12 weeks))
- Short Physical Performance Battery- (SPPB)(baseline, post- intervention (12 weeks))
- Exercise Adherence Rating Scale (EARS)(end of 4 weeks of intervention, end of 8 weeks of intervention, end of intervention (12 weeks))
- Word Finding Questionnaire - Brief Version (WoFi-Brief)(baseline, post- intervention (12 weeks))
- Consortium to Establish a Registry for Alzheimer's Disease-CERAD constructional praxis (CP) and constructional praxis recall(baseline, post- intervention (12 weeks))
- The Neuropsychiatric Inventory-12 Item Version(baseline, post- intervention (12 weeks))
- Geriatric Depression Scale - 15 Item Version(baseline, post- intervention (12 weeks))
Investigators
Eftychia Nastou
PhD candidate
University of Patras