Impact of a Multicomponent Exercise Program on Cognitive and Functional Outcomes in Patients With Mild Cognitive Impairment

NCT07334392 | Recruiting

• 1 other identifier: 17335/01-06-2025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Walking; Balance; Cognition; Mild Cognitive Impairment

Keywords

kinetic and kinematic; balance; global cognition; executive function; attention; mci; multicomponent program; exercise; dual tasking

Outcome Measures

Primary Outcomes (6)

• Kinematic and kinetic gait assessment

  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

  baseline, post- intervention (12 weeks)

• Functional Gait Assessment (FGA)

  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

  baseline, post- intervention (12 weeks)

• mini Balance Evaluation Systems Test (mini-BESTest)

  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

  baseline, post- intervention (12 weeks)

• Montreal Cognitive Assessment (MoCA)

  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

  baseline, post- intervention (12 weeks)

• Cognitive Telephone Screening Instrument (COGTEL)

  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

  baseline, post- intervention (12 weeks)

• Stroop Test

  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

  baseline, post- intervention (12 weeks)

Secondary Outcomes (12)

• 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)

Other Outcomes (1)

• Weekly diaries

  throughout the intervention (12 weeks)

Study Arms (3)

Innovative therapeutic exercise program emphasizing in dual tasking

EXPERIMENTAL

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.

Other: Innovative therapeutic exercise program

Therapeutic exercise program

ACTIVE COMPARATOR

Participants will perform aerobic exercises, strengthening exercises and balance exercises for 60- 90 minutes/ twice a week/ three months.

Other: Therapeutic exercise program

Control group

ACTIVE COMPARATOR

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.

Other: Flyer

Interventions

Innovative therapeutic exercise program OTHER

Aerobic, strengthening and balance exercises combined with cognitive training -name: Experimental group 1 (EXP1)

Innovative therapeutic exercise program emphasizing in dual tasking

Therapeutic exercise program OTHER

Aerobic, strengthening and balance exercises without cognitive training- name: Experimental group 2 (EXP2)

Therapeutic exercise program

Flyer OTHER

The control group will receive only educational material in the form of a flyer, outlining the importance and potential benefits of physical activity, along with general lifestyle recommendations, without participating in the structured exercise intervention- name: Control group (CG)

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Patras: lead
• General University Hospital of Patras: collaborator
• Andreas Mentzelopoulos Foundation: collaborator

Study Sites (1)

Department of Physiotherapy, University of Patras

Pátrai, Greece

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Neurocognitive Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Mental Disorders; Behavior

Central Study Contacts

Eftychia A Nastou

CONTACT

+30 6948694966; eutuxianastou@gmail.com

Sofia Lampropoulou

CONTACT

lampropoulou@upatras.gr

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: PhD candidate

Model Details: Randomized Control Trial with Two Experimental Groups and one Control Group

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: January 12, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)