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

May 29, 2026 updated by: University Hospital, Bordeaux

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Executive functions (Mean z score)
Time Frame: 0 to 3 months after inclusion visit
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)
Time Frame: 6 to 9 months after inclusion visit
6 to 9 months after inclusion visit
Executive functions (Mean z score)
Time Frame: 12 to 15 months after inclusion visit
12 to 15 months after inclusion visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Senior Fitness Test score
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Body Mass Index
Time Frame: Day 0 (Inclusion visit)
Day 0 (Inclusion visit)
Energy expenditure related to physical activity (Actimetry)
Time Frame: 3 to 6 months after inclusion visit
Actimetry meseare
3 to 6 months after inclusion visit
Heart rate variability at rest
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Blood pressure
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Depression score
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Self-efficacy score
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
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
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
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
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
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
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
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
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
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
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Logic memory score
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
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
Time Frame: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit
0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit
Cerebral perfusion in the same regions of interest
Time Frame: 0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit
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
Time Frame: 0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit
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
Time Frame: 0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bordeaux
Poitiers University Hospital
Centre National de la Recherche Scientifique, France
University of Poitiers

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Michel AUDIFFREN, CNRS Poitiers
  • Study Chair: Hélène AMIEVA, University of Bordeaux
  • Principal Investigator: Michèle ALLARD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2013/22
  • 2014-A00827-40 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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