Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01553929
First received: March 8, 2012
Last updated: December 17, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment
Alzheimer's Disease
Other: Physical Training and cognitive activity (EPC group)
Other: Physical training (EP group)
Other: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Physical Trainig and Cognitive Activity on the MCI Patient

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • effectiveness of physical training [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    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:
  • Cognitive improvement [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 36
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical and cognitive activity group 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.
Active Comparator: Physical activity group Other: Physical training (EP group)
The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.
Placebo Comparator: control group Other: control group
no physical training and no cognitive activity

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553929

Contacts
Contact: Vanina OLIVERI, ARC 0033 4 92 03 42 54 oliveri.v@chu-nice.fr

Locations
France
CHU de Nice Recruiting
Nice, France, 06000
Contact: Franck Le Duff, PH         
Principal Investigator: Franck Le Duff, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Franck LE DUFF, PH CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01553929     History of Changes
Other Study ID Numbers: 11-AOI-03
Study First Received: March 8, 2012
Last Updated: December 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nice:
MCI

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014