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

Mild Cognitive Impairment Clinical Trial

— EPAC-M  

Official title:

Physical Trainig and Cognitive Activity on the MCI Patient

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01553929
• Other study ID #: 11-AOI-03
• Status: Terminated
• Phase: N/A
• First received: March 8, 2012
• Last updated: August 13, 2015
• Start date: March 2012
• Est. completion date: January 2015

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.
• Physical training (EP group)
The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.
• control group
no physical training and no cognitive activity

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

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