Pathological and Non-pathological Aging, Physical Activity, Genotype and Cognition

NCT02520232 | Completed

• 1 other identifier: CHUBX 2013/22
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

Brief Summary

Alzheimer's disease (AD) is an irreversible, progressive brain disease. It is the most common form of dementia and the major cause of functional dependence in the elderly. Since there is currently no cure for Alzheimer's disease, a growing number of scientists pointed out the interest to use non-pharmacological alternative therapeutic approaches in order to slow down the decline of physical and cognitive resources and improve quality of life of patients with Alzheimer's disease. Several narrative and meta-analytical reviews suggest that regular practice of physical activity delays the occurrence of cognitive decline and slows down Alzheimer's disease progress when compared with sedentary people. Despite the growing interest of the scientific community for the positive effects of chronic exercise on mental health and cognitive functions, the clinical reality of this phenomenon remains to be clearly established, more particularly in aged people suffering from neurodegenerative diseases.The first aim of this research project is to test if chronic exercise reduces and even compensates for a cognitive decline in both patients with prodromal Alzheimer's disease (i.e., no dementia) and aging people with no pathology of central nervous system. The second aim of this research project is to examine whether an increasing of cerebral blood flow induced by chronic exercise can explain this positive effect.

Conditions

Alzheimer's Disease

Keywords

chronic exercise; genetic polymorphisms; brain imagery; executive functions; alzheimer's disease

Outcome Measures

Primary Outcomes (3)

• Executive functions (Mean z score)

  Mean z score of performances in five tasks involving executive functions (Trail Making Test, Random Number Generation Task, Stroop Color Word Test, Eriksen's Flanker Task, Letter Running Span Task).

  0 to 3 months after inclusion visit

• Executive functions (Mean z score)

  6 to 9 months after inclusion visit

• Executive functions (Mean z score)

  12 to 15 months after inclusion visit

Secondary Outcomes (17)

• Senior Fitness Test score

  0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit

• Body Mass Index

  Day 0 (Inclusion visit)

• Energy expenditure related to physical activity (Actimetry)

  3 to 6 months after inclusion visit

• Heart rate variability at rest

  0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit

• Blood pressure

  0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit

Study Arms (3)

Physical activity program (A)

EXPERIMENTAL

Physical exercises

Behavioral: Combination of aerobic and strength exercises

Physical activity program (B)

EXPERIMENTAL

Physical exercises

Behavioral: Stretching and balance exercise program

Control

NO INTERVENTION

No physical exercices assigned by the protocol

Interventions

Combination of aerobic and strength exercises BEHAVIORAL

Combination of aerobic and strength exercises

Physical activity program (A)

Stretching and balance exercise program BEHAVIORAL

Stretching and balance exercise program

Physical activity program (B)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 60 and 80 years
• Retired
• Complete autonomy on the following four instrumental activities of daily living scales (IADL) : ability to use telephone, mode of transportation, responsibility for own medications and ability to handle finances, level of physical activity practice ≤ 2
• ≤ BMI \< 40
• MMSE ≥ 25
• For prodromal Alzheimer Disease patients : subjective memory complaints of the participant, objective evidence of impaired encoding in episodic memory (Grober-Buschke free recall score \< 17).

You may not qualify if:

• Presence of a counter-indication for Magnetic Resonance Imaging , presence of a counter-indication for Positron Emission TomographyScan with \[18F\]-Flutemetamol, presence of any health problem preventing travel to the imaging service of the University Hospital, being under the legal guardianship of another person or being unable to provide consent to participate

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Poitiers University Hospital: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• University of Poitiers: collaborator
• University of Bordeaux: collaborator

Study Sites (2)

University Hospital Bordeaux, France

Bordeaux, 33076, France

Location

University Hospital, Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Michèle ALLARD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Michel AUDIFFREN

  CNRS Poitiers

  STUDY CHAIR

• Hélène AMIEVA

  University of Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 11, 2015
• Study Start: June 1, 2015
• Primary Completion: February 10, 2017
• Study Completion: May 11, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

FR (2)