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

NCT ID: NCT01553929

Last Updated: 2015-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-01-31

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.

Detailed Description

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Conditions

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Mild Cognitive Impairment Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Physical and cognitive activity group

Group Type EXPERIMENTAL

Physical Training and cognitive activity (EPC group)

Intervention Type OTHER

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.

Physical activity group

Group Type ACTIVE_COMPARATOR

Physical training (EP group)

Intervention Type OTHER

The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.

control group

Group Type PLACEBO_COMPARATOR

control group

Intervention Type OTHER

no physical training and no cognitive activity

Interventions

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Physical Training and cognitive activity (EPC group)

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.

Intervention Type OTHER

Physical training (EP group)

The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.

Intervention Type OTHER

control group

no physical training and no cognitive activity

Intervention Type OTHER

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franck LE DUFF, PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

Other Identifiers

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11-AOI-03

Identifier Type: -

Identifier Source: org_study_id

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