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Recruiting NCT07334392

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

No phase Interventional Mild Cognitive Impairment Walking Balance Cognition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Innovative therapeutic exercise program, Therapeutic exercise program, Flyer.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment, Walking, Balance, Cognition. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of an Innovative Therapeutic Exercise Program on Physical and Cognitive Function in Mild Cognitive Impairment Due to Alzheimer's Disease

Overview

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.

Interventions

  • Other Innovative therapeutic exercise program
    Aerobic, strengthening and balance exercises combined with cognitive training -name: Experimental group 1 (EXP1)
  • Other Therapeutic exercise program
    Aerobic, strengthening and balance exercises without cognitive training- name: Experimental group 2 (EXP2)
  • Other Flyer
    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)

Primary outcome measures

  • Kinematic and kinetic gait assessment [Time frame: baseline, post- intervention (12 weeks)]
  • Functional Gait Assessment (FGA) [Time frame: baseline, post- intervention (12 weeks)]
  • mini Balance Evaluation Systems Test (mini-BESTest) [Time frame: baseline, post- intervention (12 weeks)]
  • Montreal Cognitive Assessment (MoCA) [Time frame: baseline, post- intervention (12 weeks)]
  • Cognitive Telephone Screening Instrument (COGTEL) [Time frame: baseline, post- intervention (12 weeks)]
  • Stroop Test [Time frame: baseline, post- intervention (12 weeks)]
Secondary outcome measures (12)
  • Lipid profile [Time frame: baseline, post- intervention (12 weeks)]
  • Hand grip strength test [Time frame: baseline, post- intervention (12 weeks)]
  • 30 Second Sit to Stand Test [Time frame: baseline, post- intervention (12 weeks)]
  • Falls Efficacy Scale - International (FES-I) [Time frame: baseline, post- intervention (12 weeks)]
  • 6 Minute Walk Test (6MWT) [Time frame: baseline, post- intervention (12 weeks)]
  • Timed Up and Go test (TUG) [Time frame: baseline, post- intervention (12 weeks)]
  • Short Physical Performance Battery- (SPPB) [Time frame: baseline, post- intervention (12 weeks)]
  • Exercise Adherence Rating Scale (EARS) [Time frame: end of 4 weeks of intervention, end of 8 weeks of intervention, end of intervention (12 weeks)]
  • Word Finding Questionnaire - Brief Version (WoFi-Brief) [Time frame: baseline, post- intervention (12 weeks)]
  • Consortium to Establish a Registry for Alzheimer's Disease-CERAD constructional praxis (CP) and constructional praxis recall [Time frame: baseline, post- intervention (12 weeks)]
  • Geriatric Depression Scale - 15 Item Version [Time frame: baseline, post- intervention (12 weeks)]
  • The Neuropsychiatric Inventory-12 Item Version [Time frame: baseline, post- intervention (12 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Greece · 1 center
  • Department of Physiotherapy, University of Patras — Pátrai

Identifiers

NCT: NCT07334392 · 17335/01-06-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗