Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
MARAE
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMay 29, 2018
May 1, 2018
2.4 years
September 7, 2016
May 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF.
Up to 4 months
Secondary Outcomes (6)
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
Up to 4 months
Stress test
Up to 4 months
- +1 more secondary outcomes
Study Arms (2)
Endurance Training
ACTIVE COMPARATORThe 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.
Control group
ACTIVE COMPARATOR20 persons will be in the control group and they will not perform the endurance training. However, they will have 9 therapeutic education meetings.
Interventions
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.
Group of 20 people will be the control group and will not perform ET. However, they will have 9 therapeutic education meetings.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Martinique
Fort-de-France, 97261, Martinique
Related Publications (1)
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.
PMID: 31921371DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Luc Ms FANON, Doctor
CHU de Martinique
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2016
First Posted
November 21, 2016
Study Start
July 1, 2015
Primary Completion
December 1, 2017
Study Completion
February 1, 2018
Last Updated
May 29, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share