Clinical trial NCT03923712: Exercise, Brain, Cognition, OMICs, Molecular Markers and Functionality in People at Risk of Mild Cognitive Impairment
Official title: Effect of Supervised Physical Exercise on Brain, Cognition, OMICs, Molecular Markers and Functional Status in Older People at Risk of Mild Cognitive Impairment: Rationale, Design and Methodology.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Dementia
Keywords: Physical exercise
ageing
dementia
Alzheimer
magnetic resonance image
cerebral
cognition
metabolomic
older people
mild cognitive impairment
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Centro de Excelencia en Metabolómica y Bioanálisis (CEMBIO)
name: Servicio Central de Neuroimagen de la Universidad Pablo de Olavide
name: Consejería de Salud y Bienestar Social, Andalucía
First posted: 2019-04-23
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project aims to examine the effect of a 5-month period supervised exercise intervention on brain, cognition, OMICs, Molecular Markers and functional status in older people at risk of mild cognitive impairment. Secondarily, the effect of this intervention on antioxidant capacity, lipid metabolism and glucose, physical health (functional capacity, blood pressure, body composition) and mental (quality of life and depression) will be studied, as well as other factors risk (genetic and biological) for the development of Alzheimer. A total of 100 people aged between 65 and 75 years old at risk of mild cognitive impairment will be randomly distributed in the supervised exercise intervention group (n = 50) and control group (n = 50). The design will include a 5-month intervention with measurements at pre and post intervention and a third measurement (retest) after 3 months of completion. The multicomponent supervised exercise program will include aerobic, strength, cognitive and coordinative-agility-balance works, and progression will be established in different load parameters (frequency, volume, intensity, density). Therefore, randomized controlled studies are needed to know the specific effect of dose-response considering the various dimensions in parallel such as neuroimaging, cognitive status and OMICS. This will allow us to understand from a comprehensive perspective the causes and mechanisms underlying the response. This project will significantly increase scientific knowledge about the role of exercise on brain as a therapeutic measure in people at risk of mild cognitive impairment from a multidimensional perspective. The project will have a significant impact at social and economic level by transferring the study findings to social and health setting by means of agents and networks provided for the project.


Eligibility criteria: Inclusion Criteria:

* Do not present any physical illness that prevents you from doing physical activity
* Able to communicate without problems
* Able to read and understand informed consent as well as the object of the study

Exclusion Criteria:

* Acute or terminal illness
* Diagnosis of Alzheimer's
* History of cranioencephalic trauma with loss of consciousness
* History of cerebral infarction, epilepsy, brain tumor
* Unstable cardiovascular disease
* Recent fracture in upper or lower limb
* Alcohol abuse and / or habitual drug use or drug infusion pump
* Presence of pacemakers, defibrillator, metallic implants in the head, intraocular and / or maxillo-facial structures, dental prostheses incompatible with magnetic resonance studies
* Intravascular devices (stent, Coil, filter), heart valve, aneurysm clip, neurostimulator, intravascular catheter with metal or cardiovascular bypass
* Severe visual or auditory problems, implant in the middle / inner ear
* Do not want to complete the study or be assigned to the control group
* He/she is participating in another research study that may influence the present project.

Primary outcomes:
measure: Assessed changes from Baseline Neuroimaging Markers of Brain Structures (thickness in mm; volumes in mm)
timeFrame: up to 24 weeks
measure: Assessed changes from Baseline Neuroimaging Markers of Brain Function (level of activity in percentage)
timeFrame: up to 24 weeks
measure: Assessed changes from Baseline Cognitive Status
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline OMICs Analysis
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Molecular Makers
timeFrame: up to 36 weeks
Secondary outcomes:
measure: Assessed changes from Baseline Physical Health Parameters on Functional capacity: Muscle-skeletal
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health Parameters on Functional capacity: Cardiorespiratory fitness
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health Parameters on Functional capacity:Agility-motor coordination
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health Parameters on Functional capacity: Flexibility
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health Parameters on Functional capacity: Handgrip strength
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Incremental Exercise test:
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health by the Scale of instrumental activities of the daily life of Lawton and Brody
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health of hemodynamic status
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health of Body Composition: Weight
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health of Body Composition:Height
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health of Body Composition: Waist Circumference
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health of Body Composition: Body mass index
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Physical Health of Body Composition: Total body fluids
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile: Glucose.
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile:Total cholesterol
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile:HDL cholesterol
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile: LDL Cholesterol
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile:triglycerides
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile:Apolipoprotein B
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile:Insulin
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile: HOMA
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Antioxidant Capacity
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline Blood Sample of the Neurotrophic Factor Derived from the Brain (neurotransmitter)
timeFrame: up to 36 weeks
measure: Assessed of Baseline levels for Cerebrospinal fluid:
timeFrame: baseline
measure: Assessed changes from Baseline Quality of life as assessed through the quality of life questionnaire related to health (Short-Form Health Survey 36 -SF36)
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline of Depression using the Geriatric Depression Scale (GDS)
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline of Sociodemographic Characteristics: Age.
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline of Sociodemographic Characteristics.Sex.
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline of Sociodemographic Characteristics.Marital Status.
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline of Sociodemographic Characteristics.Educational level and socio-economic status.
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline of Sociodemographic Characteristics.Family history of dementia.
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline of Sociodemographic Characteristics.Medication.
timeFrame: up to 36 weeks
measure: Assessed changes from Baseline of Sociodemographic Characteristics. Other pathologies.
timeFrame: up to 36 weeks
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: University of Cádiz
Study officials:
affiliation: University of Cádiz
name: David Jiménez Pavón, PhD
role: PRINCIPAL_INVESTIGATOR
References: