Clinical trial NCT02968875: Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
Official title: Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: endurance training
BDNF analysis
cognitive function
physiological abilities
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient who refused to provide written consent
* Inability to pedal
* Recent myocardial necrosis (less than 3 months)
* Aortic Stenosis
* Uncompensated heart failure
* Unstable angina
* Ventricular arrythmia
* Pulmonary embolism
* Coxarthrosis, knee, ankle osteoarthritis
* Not affiliated to a social security
* Patient already participating in another biomedical research

Primary outcomes:
measure: Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.
timeFrame: Up to 4 months
Secondary outcomes:
measure: Measuring the effect of training on the psychological performance by using questionnaire MMSE
timeFrame: Up to 4 months
measure: Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)
timeFrame: Up to 4 months
measure: Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)
timeFrame: Up to 4 months
measure: Stress test
timeFrame: Up to 4 months
measure: Stress test
timeFrame: Up to 4 months
measure: Measuring the effect of training on the physiological performance with a walk test of 6 minutes.
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: CHU de Martinique
name: Jean-Luc Ms FANON, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.