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Completed

NCT Number: NCT02968875

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Martinique

Fort-de-France, 97261, Martinique

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endurance Training

Device

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.

therapeutic education meetings

Other

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

Primary outcomes

  1. Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.

    Time frame: Up to 4 months

Secondary outcomes

  1. Measuring the effect of training on the psychological performance by using questionnaire MMSE

    Time frame: Up to 4 months

  2. Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT)

    Time frame: Up to 4 months

  3. Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD)

    Time frame: Up to 4 months

  4. Stress test

    Time frame: Up to 4 months

    Measuring the effect of training on the physiological performance by determining the maximum power of the effort tolerated

  5. Stress test

    Time frame: Up to 4 months

    Measuring the effect of training on the physiological performance by determining the grip strength

  6. Measuring the effect of training on the physiological performance with a walk test of 6 minutes.

    Time frame: Up to 4 months

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Registry information

Acronym: MARAE

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 21, 2016
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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