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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02968875
Other study ID # 15/B/03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date February 2018

Study information

Verified date May 2018
Source University Hospital Center of Martinique
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date February 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Endurance Training
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.
Other:
therapeutic education meetings
Group of 20 people will be the control group and will not perform ET. However, they will have 9 therapeutic education meetings.

Locations

Country Name City State
Martinique CHU de Martinique Fort-de-France

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF. Up to 4 months
Secondary Measuring the effect of training on the psychological performance by using questionnaire MMSE Up to 4 months
Secondary Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT) Up to 4 months
Secondary Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD) Up to 4 months
Secondary Stress test Measuring the effect of training on the physiological performance by determining the maximum power of the effort tolerated Up to 4 months
Secondary Stress test Measuring the effect of training on the physiological performance by determining the grip strength Up to 4 months
Secondary Measuring the effect of training on the physiological performance with a walk test of 6 minutes. Up to 4 months
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