Mild Cognitive Impairment Clinical Trial
— EPAC-MOfficial title:
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | January 2015 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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