Physical Training and Cognitive Activity on the Mild Cognitive Impairment (MCI) Patient

Study Overview
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Brief Summary
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Regular physical activity is now recognized as a key element of good physical and mental health and this all ages. MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive training in improving the cognitive function of patients diagnosed with Mild Cognitive Impairment (MCI). DESIGN : Controlled randomized monocentric and prospective study with clinical benefit for the patient with three groups : one physical training and cognitive exercise group, one physical training without cognitive exercise group and one control group. In agreement with the literature on the effects of physiological stress on cognitive performance, the investigators expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire. Furthermore the investigators hypothesize that this positive effect is greater in the physical training and cognitive exercise group compared with the physical training group only.

Official Title
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Physical Trainig and Cognitive Activity on the MCI Patient

Conditions
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Mild Cognitive Impairment, Alzheimer's Disease

Intervention / Treatment
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* Other: Physical Training and cognitive activity (EPC group)
* Other: Physical training (EP group)
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed patient MCI (Mild Cognitive Impairment) Elderly from 40 to 75 years old MMSE upper to 22 Affiliated or beneficiary of a national insurance scheme Medical capacity to the physical proposed activity (filling of the conditions of the Medical certificate of not contraindication in the sport) Exclusion Criteria: The placed persons under guardianship, under protection of justice, The private persons of freedom (administrative or judicial) Nobody already participating in a clinical trial

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical and cognitive activity group<br> | Other: Physical Training and cognitive activity (EPC group)<br>* The patients of the EPC group will realize 2 weekly sessions of 20 minutes of pédalage. During the exercise, the patients will realize a series of tests of decision-making and perceptive cognitive capacity.<br>|
| Active Comparator: Physical activity group<br> | Other: Physical training (EP group)<br>* The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.<br>|
| Placebo Comparator: control group<br> | Other: control group<br>* no physical training and no cognitive activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of physical training | Assess the effectiveness of physical training associated with a cognitive training in improving the cognitive functions of patients diagnosed with Mild Cognitive Impairment (MCI). We expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive improvement | Assess the cognitive improvement after three months and after cessation of the intervention. Assess the impact of the intervention on the cognitive and behavioral, 3 months after cessation of training with maintenance of physical activity by patients. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCI