Back to resultsAlzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training (MARAE)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Martinique
Study Type
Interventional
Intervention
Endurance Training
therapeutic education meetings
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer's Disease focused on measuring endurance training, BDNF analysis, cognitive function, physiological abilities
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
Sites / Locations
- CHU de Martinique
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Endurance Training
Control group
Arm Description
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.
20 persons will be in the control group and they will not perform the endurance training. However, they will have 9 therapeutic education meetings.
Outcomes
Primary Outcome Measures
Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.
Secondary Outcome Measures
Measuring the effect of training on the psychological performance by using questionnaire MMSE
Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)
Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)
Stress test
Measuring the effect of training on the physiological performance by determining the maximum power of the effort tolerated
Stress test
Measuring the effect of training on the physiological performance by determining the grip strength
Measuring the effect of training on the physiological performance with a walk test of 6 minutes.
Full Information
NCT ID
NCT02968875
First Posted
September 7, 2016
Last Updated
May 24, 2018
Sponsor
University Hospital Center of Martinique
1. Study Identification
Unique Protocol Identification Number
NCT02968875
Brief Title
Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
Acronym
MARAE
Official Title
Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
endurance training, BDNF analysis, cognitive function, physiological abilities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endurance Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
20 persons will be in the control group and they will not perform the endurance training. However, they will have 9 therapeutic education meetings.
Intervention Type
Device
Intervention Name(s)
Endurance Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
therapeutic education meetings
Intervention Description
Group of 20 people will be the control group and will not perform ET. However, they will have 9 therapeutic education meetings.
Primary Outcome Measure Information:
Title
Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Measuring the effect of training on the psychological performance by using questionnaire MMSE
Time Frame
Up to 4 months
Title
Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)
Time Frame
Up to 4 months
Title
Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)
Time Frame
Up to 4 months
Title
Stress test
Description
Measuring the effect of training on the physiological performance by determining the maximum power of the effort tolerated
Time Frame
Up to 4 months
Title
Stress test
Description
Measuring the effect of training on the physiological performance by determining the grip strength
Time Frame
Up to 4 months
Title
Measuring the effect of training on the physiological performance with a walk test of 6 minutes.
Time Frame
Up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Ms FANON, Doctor
Organizational Affiliation
CHU de Martinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Martinique
City
Fort-de-France
ZIP/Postal Code
97261
Country
Martinique
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31921371
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.
Results Reference
derived
Learn more about this trial
Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
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