- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01553929
Physical Training and Cognitive Activity on the Mild Cognitive Impairment (MCI) Patient (EPAC-M)
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
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Nice, France, 06000
- CHU de Nice
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
no physical training and no cognitive activity
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Active Comparator: Physical activity group
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The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.
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Experimental: Physical and cognitive activity group
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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
Investigators
- Principal Investigator: Franck LE DUFF, PH, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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