Alzheimer's DiseaseMARAENCT02968875
Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
A study testing Endurance Training and therapeutic education meetings in people with Alzheimer's Disease, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
Alzheimer's disease (AD) is a neurodegenerative disease leading to one of the most common forms of dementia in humans and memory disorder is one of the first symptoms that lead to diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Endurance Training and therapeutic education meetings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMartinique
- Study dates
- Jul 2015to Feb 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Alzheimer's disease patients diagnosed by a consultation memory (DSM- IV)
- Person with at least 60 years
- Person with a score higher than 15 in the Mini Mental State Examination
- No one can achieve the pedaling motion
- People who do not perform regular physical activity on bike
- Nobody has given free and informed consent in writing or obtained from a trusted person or the family environment
- People affiliated to a social security
Who cannot join
- Patient who refused to provide written consent
- Inability to pedal
- Recent myocardial necrosis (less than 3 months)
- Aortic Stenosis
- Uncompensated heart failure
- Unstable angina
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- Ventricular arrythmia
- Pulmonary embolism
- Coxarthrosis, knee, ankle osteoarthritis
- Not affiliated to a social security
- Patient already participating in another biomedical research
Trial locations and contacts
1 site in 1 country.
About this study
Alzheimer's disease (AD) is a neurodegenerative disease leading to one of the most common forms of dementia in humans and memory disorder is one of the first symptoms that lead to diagnosis.
Read the detailed description
Present in greater amounts in the regions of the hippocampus and cortex, the Brain-derived neurotrophic factor (BDNF) is essential to both learning and memory processes. This protein is found in lower amounts in people with AD. Acute physical activity of moderate to vigorous intensity would increase the levels of plasma BDNF whether for a healthy person or a person with AD. Nevertheless in rest, healthy people have higher level of BDNF than individuals with AD. There are no studies on the effect of chronic exercise based on BDNF level at rest in people with AD. In a hypothetical endurance training of 18 sessions, whether interval or continuous training the levels of BDNF would increase in people with AD at rest. Their physiological and neuropsychological performances would also show a rise.
- Conditions
- Alzheimer's Disease
- Being tested
- Endurance Training, therapeutic education meetings
- Keywords
- endurance training, BDNF analysis, cognitive function, physiological abilities
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance TrainingDevice
40 people will submitted to endurance training: 20 will perform a continuous training and 20 will perform an interval training. The variables that will be analyzed are maximum aerobic power, endurance, heart rate, prehension strength, Mini-Mental State Examination (MMSE), REY's test, biological examination and level of BDNF plasma, before and after the intervention and one month after the end of the intervention and one month after the end of the intervention.
therapeutic education meetingsOther
Group of 20 people will be the control group and will not perform ET. However, they will have 9 therapeutic education meetings.
| Study group | Role | What they receive |
|---|---|---|
| Endurance Training | Active comparator | The first group of 40 people will do endurance training; 20 of them will perform a continuous exercise on cycle ergometer at a power equivalent to 70% of the maximal heart rate, twice a week. The other group will do Interval Training, with a four minute long base and one minute long peak, twice a week. The base workload will be equivalent to an intensity of 60% of the maximal heart rate and the peak will be equivalent to 80% of the maximal heart rate. Receives: Device: Endurance Training |
| Control group | Active comparator | 20 persons will be in the control group and they will not perform the endurance training. However, they will have 9 therapeutic education meetings. Receives: Other: therapeutic education meetings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.
Measured: Up to 4 months
Secondary outcomes (6)
Measuring the effect of training on the psychological performance by using questionnaire MMSE
Measured: Up to 4 months
Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)
Measured: Up to 4 months
Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)
Measured: Up to 4 months
Stress test
Measuring the effect of training on the physiological performance by determining the maximum power of the effort tolerated
Measured: Up to 4 months
Stress test
Measuring the effect of training on the physiological performance by determining the grip strength
Measured: Up to 4 months
Measuring the effect of training on the physiological performance with a walk test of 6 minutes.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Ms FANON, Doctor, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968875
- Sponsor's protocol ID
- 15/B/03
- Acronym
- MARAE
- Status last verified
- May 2018
- First submitted
- 7 Sep 2016
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Enette L, Vogel T, Merle S, Valard-Guiguet AG, Ozier-Lafontaine N, Neviere R, Leuly-Joncart C, Fanon JL, Lang PO. Effect of 9 weeks continuous vs. interval aerobic training on plasma BDNF levels, aerobic fitness, cognitive capacity and quality of life among seniors with mild to moderate Alzheimer's disease: a randomized controlled trial. Eur Rev Aging Phys Act. 2020 Jan 6;17:2. doi: 10.1186/s11556-019-0234-1. eCollection 2020.
PubMed 31921371
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
- ClinicalTrials.gov ID
- NCT02968875
- Acronym / sponsor ID
- MARAE / 15/B/03
- Conditions
- Alzheimer's Disease
- Keywords
- endurance training, BDNF analysis, cognitive function, physiological abilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 21 Nov 2016 (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 a neurodegenerative disease leading to one of the most common forms of dementia in humans and memory disorder is one of the first symptoms that lead to diagnosis.
Detailed description
Present in greater amounts in the regions of the hippocampus and cortex, the Brain-derived neurotrophic factor (BDNF) is essential to both learning and memory processes. This protein is found in lower amounts in people with AD. Acute physical activity of moderate to vigorous intensity would increase the levels of plasma BDNF whether for a healthy person or a person with AD. Nevertheless in rest, healthy people have higher level of BDNF than individuals with AD. There are no studies on the effect of chronic exercise based on BDNF level at rest in people with AD. In a hypothetical endurance training of 18 sessions, whether interval or continuous training the levels of BDNF would increase in people with AD at rest. Their physiological and neuropsychological performances would also show a rise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance Training | Active comparator | Device: Endurance TrainingThe first group of 40 people will do endurance training; 20 of them will perform a continuous exercise on cycle ergometer at a power equivalent to 70% of the maximal heart rate, twice a week. The other group will do Interval Training, with a four minute long base and one minute long peak, twice a week. The base workload will be equivalent to an intensity of 60% of the maximal heart rate and the peak will be equivalent to 80% of the maximal heart rate. |
| Control group | Active comparator | Other: therapeutic education meetings20 persons will be in the control group and they will not perform the endurance training. However, they will have 9 therapeutic education meetings. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Alzheimer's disease patients diagnosed by a consultation memory (DSM- IV)
- Person with at least 60 years
- Person with a score higher than 15 in the Mini Mental State Examination
- No one can achieve the pedaling motion
- People who do not perform regular physical activity on bike
Key exclusion criteria (11 listed)
- Patient who refused to provide written consent
- Inability to pedal
- Recent myocardial necrosis (less than 3 months)
- Aortic Stenosis
- Uncompensated heart failure
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 |
|---|---|---|
| Endurance Training40 people will submitted to endurance training: 20 will perform a continuous training and 20 will perform an interval training. The variables that will be analyzed are maximum aerobic power, endurance, heart rate, prehension strength, Mini-Mental State Examination (MMSE), REY's test, biological examination and level of BDNF plasma, before and after the intervention and one month after the end of the intervention and one month after the end of the intervention. | Device | Endurance Training |
| therapeutic education meetingsGroup of 20 people will be the control group and will not perform ET. However, they will have 9 therapeutic education meetings. | Other | Control group |
Primary outcome
Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.
Time frame: Up to 4 months
6 secondary outcomes
Measuring the effect of training on the psychological performance by using questionnaire MMSE
Time frame: Up to 4 months
Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)
Time frame: Up to 4 months
Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)
Time frame: Up to 4 months
Stress test
Time frame: Up to 4 months
Stress test
Time frame: Up to 4 months
Measuring the effect of training on the physiological performance with a walk test of 6 minutes.
Time frame: Up to 4 months
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 29 May 2018.
- Derived from this study: PubMed 31921371Enette L, Vogel T, Merle S, Valard-Guiguet AG, Ozier-Lafontaine N, Neviere R, Leuly-Joncart C, Fanon JL, Lang PO. Effect of 9 weeks continuous vs. interval aerobic training on plasma BDNF levels, aerobic fitness, cognitive capacity and quality of life among seniors with mild to moderate Alzheimer's disease: a randomized controlled trial. Eur Rev Aging Phys Act. 2020 Jan 6;17:2. doi: 10.1186/s11556-019-0234-1. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Jean-Luc Ms FANON, Doctor principal investigator
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance Training and therapeutic education meetings in people with Alzheimer's Disease, run by University Hospital Center of Martinique at 1 site in Martinique.
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 7 inclusion and 11 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 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. 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?
Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF. (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968875, which also lists 1 linked publication.
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 29 May 2018.