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

NCT01553929 | Terminated

• 1 other identifier: 11-AOI-03
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Keywords

MCI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cognitive improvement

  up to 3 months

Study Arms (3)

Physical and cognitive activity group

EXPERIMENTAL

Other: Physical Training and cognitive activity (EPC group)

Physical activity group

ACTIVE COMPARATOR

Other: Physical training (EP group)

control group

PLACEBO COMPARATOR

Other: control group

Interventions

Physical Training and cognitive activity (EPC group) OTHER

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 and cognitive activity group

Physical training (EP group) OTHER

The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.

Physical activity group

control group OTHER

no physical training and no cognitive activity

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• The placed persons under guardianship, under protection of justice,
• The private persons of freedom (administrative or judicial)
• Nobody already participating in a clinical trial

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Franck LE DUFF, PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 14, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: January 1, 2015
• Last Updated: August 14, 2015

Record last verified: 2015-08

Locations

FR (1)