Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training (MARAE)

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Device: Endurance Training; Other: therapeutic education meetings

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Martinique
  • Fort-de-France, Martinique, 97261
    • CHU de Martinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endurance Training; 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.	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.
Active Comparator: Control group; 20 persons will be in the control group and they will not perform the endurance training. However, they will have 9 therapeutic education meetings.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the effect of training on the psychological performance by using questionnaire MMSE		Up to 4 months
Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)		Up to 4 months
Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)		Up to 4 months
Stress test	Measuring the effect of training on the physiological performance by determining the maximum power of the effort tolerated	Up to 4 months
Stress test	Measuring the effect of training on the physiological performance by determining the grip strength	Up to 4 months
Measuring the effect of training on the physiological performance with a walk test of 6 minutes.		Up to 4 months

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique
• Investigators: Principal Investigator: Jean-Luc Ms FANON, Doctor, CHU de Martinique

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2018
• Last Update Submitted That Met QC Criteria: May 24, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: cognitive function; endurance training; BDNF analysis; physiological abilities
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 15/B/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO