Physical Training and Cognitive Activity on the Mild Cognitive Impairment (MCI) Patient (EPAC-M)
Primary Purpose
Mild Cognitive Impairment, Alzheimer's Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical Training and cognitive activity (EPC group)
Physical training (EP group)
control group
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring MCI
Eligibility Criteria
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
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Physical and cognitive activity group
Physical activity group
control group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01553929
First Posted
March 8, 2012
Last Updated
August 13, 2015
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01553929
Brief Title
Physical Training and Cognitive Activity on the Mild Cognitive Impairment (MCI) Patient
Acronym
EPAC-M
Official Title
Physical Trainig and Cognitive Activity on the MCI Patient
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer's Disease
Keywords
MCI
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical and cognitive activity group
Arm Type
Experimental
Arm Title
Physical activity group
Arm Type
Active Comparator
Arm Title
control group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Physical Training and cognitive activity (EPC group)
Intervention Description
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
Intervention Name(s)
Physical training (EP group)
Intervention Description
The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
no physical training and no cognitive activity
Primary Outcome Measure Information:
Title
effectiveness of physical training
Description
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.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Cognitive improvement
Description
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.
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck LE DUFF, PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Physical Training and Cognitive Activity on the Mild Cognitive Impairment (MCI) Patient
We'll reach out to this number within 24 hrs