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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Patras

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Innovative therapeutic exercise program

    Other intervention

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

  • Therapeutic exercise program

    Other intervention

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

  • Flyer

    Other intervention

    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)

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Innovative therapeutic exercise program emphasizing in dual taskingExperimental treatment 1 intervention
Group B: Therapeutic exercise programActive comparator 1 intervention
Group C: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
baseline, post- intervention (12 weeks)
2

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

Time frame
baseline, post- intervention (12 weeks)
3

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

Time frame
baseline, post- intervention (12 weeks)
4

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

Time frame
baseline, post- intervention (12 weeks)

Secondary outcomes

1

Lipid profile

Plasma samples will be collected from the participants and will be analyzed using standardized biochemical and immunoassay techniques. The samples will be analyzed to assess changes associated with the intervention. Parameters Measured: total cholesterol Blood sample collection: ≈ 5 minutes

Time frame
baseline, post- intervention (12 weeks)
2

Hand grip strength test

The Hand Grip Strength Test is a widely used assessment of upper limb muscle strength, particularly of the forearm and hand flexor muscles. The test measures maximum isometric grip force, which reflects not only upper limb strength but also overall muscle function.The participant holds the dynamometer and squeezes as hard as possible for 3-5 seconds. Three trials are performed per hand, with 30-60 seconds of rest between trials. The mean score of the three trials (kg) are reported for each hand. Results are compared to age- and sex-specific normative data. Administration time: ≈ 3- 5 minutes

Time frame
baseline, post- intervention (12 weeks)
3

30 Second Sit to Stand Test

The 30-Second Sit-to-Stand Test (also known as the 30-Second Chair Stand Test) is a simple, reliable measure of lower limb strength, endurance, and functional mobility. Participant sits in the middle of the chair, back straight, feet flat on the floor, shoulder-width apart, and arms crossed over the chest. On the command "Go," the participant stands up fully and sits down as many times as possible within 30 seconds. The participant must fully extend the knees and hips when standing and sit back fully each time. Partial stands do not count. The assessor counts the number of completed stands within 30 seconds. More repetitions indicate better lower-body strength and endurance. Scores below age- and sex-specific norms indicate reduced lower-body strength and increased fall risk. Administration time: ≈2-3 minutes

Time frame
baseline, post- intervention (12 weeks)
4

Falls Efficacy Scale - International (FES-I)

The Falls Efficacy Scale - International (FES-I) is a standardized self-report questionnaire designed to assess an individual's concern or fear of falling during various everyday activities. The original FES-I includes 16 items, each describing a common daily activity. Participants rate their concern about falling while performing each activity, regardless of whether they actually do it. Each item is rated on a 4-point Likert scale: 1 (Not at all concerned)-4 (Very concerned). Total Score: 16-64 points. Higher scores indicate greater concern about falling and lower confidence in performing activities safely. Administration time: ≈10 minutes

Time frame
baseline, post- intervention (12 weeks)

Other outcomes

1

Weekly diaries

Exercise providers will complete a weekly attendance and performance log for each participant enrolled in the exercise program. The log will document participant attendance, exercise compliance, and qualitative feedback on performance. This information will be used to progressively adjust the difficulty level of the exercises Duration: ≈ 15 minutes

Time frame
throughout the intervention (12 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Patras

Lead sponsor

University General Hospital of Patras

Collaborator

Andreas Mentzelopoulos Foundation

Collaborator