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

Not Applicable

Terminated

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment
• Interventions: Other: Physical Training and cognitive activity (EPC group); Other: Physical training (EP group); Other: control group

• Registration Number: NCT01553929
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-03
• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Study Completion: 2015-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-13
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical and cognitive activity group	Physical Training and cognitive activity (EPC group)	-
Physical activity group	Physical training (EP group)	-
control group	control group	-

Primary Outcome Measures

Name	Time	Method
effectiveness of physical training	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.

Secondary Outcome Measures

Name	Time	Method
Cognitive improvement	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.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France