Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02968875 |
Date of registration:
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07/09/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
MARAE |
Scientific title:
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Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training |
Date of first enrolment:
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July 2015 |
Target sample size:
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54 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02968875 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Martinique
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Contacts
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Name:
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Jean-Luc Ms FANON, Doctor |
Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Martinique |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Intervention(s)
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Device: Endurance Training
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Other: therapeutic education meetings
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Primary Outcome(s)
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Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.
[Time Frame: Up to 4 months]
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Secondary Outcome(s)
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Measuring the effect of training on the physiological performance with a walk test of 6 minutes.
[Time Frame: Up to 4 months]
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Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)
[Time Frame: Up to 4 months]
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Measuring the effect of training on the psychological performance by using questionnaire MMSE
[Time Frame: Up to 4 months]
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Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)
[Time Frame: Up to 4 months]
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Stress test
[Time Frame: Up to 4 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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