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

August 13, 2015 updated by: Centre Hospitalier Universitaire de Nice

Physical Trainig and Cognitive Activity on the MCI Patient

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
Other: control group
no physical training and no cognitive activity
Active Comparator: Physical activity group
Other: Physical training (EP group)
The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.
Experimental: Physical and cognitive activity group
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effectiveness of physical training
Time Frame: up to 3 months
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
Time Frame: up to 3 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Franck LE DUFF, PH, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-AOI-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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