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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02968875
Date of registration: 07/09/2016
Prospective Registration: No
Primary sponsor: University Hospital Center of Martinique
Public title: Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training MARAE
Scientific title: Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
Date of first enrolment: July 2015
Target sample size: 54
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02968875
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France Martinique
Contacts
Name:     Jean-Luc Ms FANON, Doctor
Address: 
Telephone:
Email:
Affiliation:  CHU de Martinique
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Alzheimer's Disease
Intervention(s)
Device: Endurance Training
Other: therapeutic education meetings
Primary Outcome(s)
Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF. [Time Frame: Up to 4 months]
Secondary Outcome(s)
Measuring the effect of training on the physiological performance with a walk test of 6 minutes. [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]
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]
Stress test [Time Frame: Up to 4 months]
Secondary ID(s)
15/B/03
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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