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Clinical Trials/NCT01553929
NCT01553929TerminatedNot Applicable

Physical Trainig and Cognitive Activity on the MCI Patient

Centre Hospitalier Universitaire de Nice1 site in 1 country5 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
5
Locations
1
Primary Endpoint
effectiveness of physical training

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

control group

Placebo Comparator

Intervention: control group (Other)

Physical and cognitive activity group

Experimental

Intervention: Physical Training and cognitive activity (EPC group) (Other)

Physical activity group

Active Comparator

Intervention: Physical training (EP group) (Other)

Outcomes

Primary Outcomes

effectiveness of physical training

Time Frame: 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 Outcomes

  • Cognitive improvement(up to 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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