Pathological and Non-pathological Aging, Physical Activity, Genotype and Cognition (VIAGECO)

Pathological and Non-pathological Aging, Physical Activity, Genotype and Cognition (VIAGECO)

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Behavioral: Combination of aerobic and strength exercises; Behavioral: Stretching and balance exercise program

Detailed Description

Several epidemiologic studies conducted in North America and in Europe have shown that the regular practice of physical activity, in opposition to a sedentary life, is associated with a reduced risk of developing neurodegenerative diseases such as AD. These results have been strengthened by cross-sectional and interventional studies, which have shown that physical activity slows down the decline of cognitive functions typically observed in normal and pathological aging and retards the onset of dementia. The positive effects of chronic exercise on cerebral and cognitive ageing are now recognised by scientists and clinicians; however, the mechanisms underlying these effects in humans are poorly understood and there is a real need for randomised controlled trial (RCT) on this topic. The objective of this research project is to understand the compensatory mechanisms that may account for the positive effects of regular physical activity on pathological and non-pathological cerebral ageing in human and in particular in people presenting prodromal AD. All participants will be separated into six groups corresponding to the combination of two independent variables: the population type (aged people without any neurological disease vs. prodromal Alzheimer's disease participants) and the type of physical activity program they will follow during six months (aerobic and strength exercise program, stretching and balance program, or maintaining sedentary life style). Cognitive performance, cardiovascular health, brain integrity and cerebral functioning will be assessed at two or three different times: before the onset of the training program (pre-test), at the end of the training period (post-test 1) and six months after the end of the training program (post-test 2).

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • University Hospital Bordeaux, France
  • Poitiers, France, 86021
    • University Hospital, Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• 18.5 ≤ 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Physical activity program (A); Physical exercises	Behavioral: Combination of aerobic and strength exercises; Combination of aerobic and strength exercises
EXPERIMENTAL: Physical activity program (B); Physical exercises	Behavioral: Stretching and balance exercise program; Stretching and balance exercise program
NO_INTERVENTION: Control; No physical exercices assigned by the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Actimetry meseare	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
Depression score		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Self-efficacy score		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Quality of life score		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Stage of change score related to physical activity		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Score at Verbal working-memory span		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Reaction time in a two-choice reaction time task		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Error rate in a two-choice reaction time task		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Logic memory score		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Grey and white matter volumes in regions of interest		0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit
Cerebral perfusion in the same regions of interest	Brain Imaging	0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit
Resting State Networks Activity	Brain Imaging	0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit
Brain glucose metabolism	Brain Imaging	0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: University of Bordeaux; Poitiers University Hospital; Centre National de la Recherche Scientifique, France; University of Poitiers
• Investigators: Study Chair: Michel AUDIFFREN, CNRS Poitiers; Study Chair: Hélène AMIEVA, University of Bordeaux

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ACTUAL): February 10, 2017
• Study Completion (ACTUAL): May 11, 2018

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (ESTIMATE): August 11, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: alzheimer's disease; genetic polymorphisms; executive functions; chronic exercise; brain imagery
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: CHUBX 2013/22