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

Centre Hospitalier Universitaire de Nice

Status: Terminated

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Treatments: Other: control group; Other: Physical training (EP group); Other: Physical Training and cognitive activity (EPC group)

Study type: Interventional

Funder types: Other

Identifiers

NCT01553929

11-AOI-03

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 3 patient groups, including a placebo group

Physical and cognitive activity group

Experimental group

Treatment:

Other: Physical Training and cognitive activity (EPC group)

Physical activity group

Active Comparator group

Treatment:

Other: Physical training (EP group)

control group

Placebo Comparator group

Treatment:

Other: control group