Alzheimer's DiseaseVIAGECONCT02520232
Pathological and Non-pathological Aging, Physical Activity, Genotype and Cognition
A study testing Combination of aerobic and strength exercises and Stretching and balance exercise program in people with Alzheimer's Disease, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Combination of aerobic and strength exercises and Stretching and balance exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2015to 11 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital Bordeaux, France
Bordeaux, 33076
University Hospital, Poitiers
Poitiers, 86021
About this study
Official title: 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.
Read the 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).
- Conditions
- Alzheimer's Disease
- Being tested
- Combination of aerobic and strength exercises, Stretching and balance exercise program
- Keywords
- chronic exercise, genetic polymorphisms, brain imagery, executive functions, alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of aerobic and strength exercisesBehavioural
Combination of aerobic and strength exercises
Stretching and balance exercise programBehavioural
Stretching and balance exercise program
| Study group | Role | What they receive |
|---|---|---|
| Physical activity program (A) | Experimental | Physical exercises Receives: Behavioral: Combination of aerobic and strength exercises |
| Physical activity program (B) | Experimental | Physical exercises Receives: Behavioral: Stretching and balance exercise program |
| Control | No intervention | No physical exercices assigned by the protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0 to 3 months after inclusion visit
Executive functions (Mean z score)
Measured: 6 to 9 months after inclusion visit
Executive functions (Mean z score)
Measured: 12 to 15 months after inclusion visit
Secondary outcomes (17)
Senior Fitness Test score
Measured: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Body Mass Index
Measured: Day 0 (Inclusion visit)
Energy expenditure related to physical activity (Actimetry)
Actimetry meseare
Measured: 3 to 6 months after inclusion visit
Heart rate variability at rest
Measured: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Blood pressure
Measured: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Depression score
Measured: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Self-efficacy score
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit ; 12 to 15 months after inclusion visit
Logic memory score
Measured: 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
Measured: 0 to 3 months after inclusion visit ; 6 to 9 months after inclusion visit
Cerebral perfusion in the same regions of interest
Brain Imaging
Measured: 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
Measured: 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
Measured: 0 to 3 months after inclusion visit ; 0 to 15 days after inclusion visit ; 6 to 9 months after inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startJun 2015
- Primary completion10 Feb 2017
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Poitiers University Hospital, Centre National de la Recherche Scientifique, France, University of Poitiers, University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Michèle ALLARD, Principal investigator, University Hospital, BordeauxMichel AUDIFFREN, Study chair, CNRS PoitiersHélène AMIEVA, Study chair, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520232
- Sponsor's protocol ID
- CHUBX 2013/22
- Other IDs
- 2014-A00827-40
- Acronym
- VIAGECO
- Status last verified
- Feb 2019
- First submitted
- 31 Jul 2015
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological and Non-pathological Aging, Physical Activity, Genotype and Cognition (VIAGECO)
- ClinicalTrials.gov ID
- NCT02520232
- Acronym / sponsor ID
- VIAGECO / CHUBX 2013/22
- Conditions
- Alzheimer's Disease
- Keywords
- chronic exercise, genetic polymorphisms, brain imagery, executive functions, alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Poitiers University Hospital, Centre National de la Recherche Scientifique, France, University of Poitiers, University of Bordeaux
- Study start
- Jun 2015 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical activity program (A) | Experimental | Behavioral: Combination of aerobic and strength exercisesPhysical exercises |
| Physical activity program (B) | Experimental | Behavioral: Stretching and balance exercise programPhysical exercises |
| Control | No intervention | –No physical exercices assigned by the protocol |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of aerobic and strength exercisesCombination of aerobic and strength exercises | Behavioural | Physical activity program (A) |
| Stretching and balance exercise programStretching and balance exercise program | Behavioural | Physical activity program (B) |
Primary outcome
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).
Executive functions (Mean z score)
Time frame: 6 to 9 months after inclusion visit
Executive functions (Mean z score)
Time frame: 12 to 15 months after inclusion visit
17 secondary outcomes
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
Body Mass Index
Time frame: Day 0 (Inclusion visit)
Energy expenditure related to physical activity (Actimetry)
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michèle ALLARD principal investigator
University Hospital, Bordeaux
Michel AUDIFFREN study chair
CNRS Poitiers
Hélène AMIEVA study chair
University of Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of aerobic and strength exercises and Stretching and balance exercise program in people with Alzheimer's Disease, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive functions (Mean z score) (time frame: 0 to 3 months after inclusion visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.