Exercise, Brain, Cognition, OMICs, Molecular Markers and Functionality in People at Risk of Mild Cognitive Impairment

University of Cadiz

Status: Completed

Conditions: Alzheimer Dementia; Mild Cognitive Impairment

Treatments: Behavioral: Supervised Exercise Programme

Study type: Interventional

Funder types: Other

Identifiers

NCT03923712

DEP2016-76123-R

PI-0002-2017 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 65 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

98 participants in 2 patient groups

Control Group

No Intervention group

Description:

Participants randomly assigned to control group will be instructed to maintain their normal life habits with respect to physical activity and diet. During the 5 months of intervention participants from this group will receive at least one call from the researchers to be interested in their health status and inform them about the next evaluation appointment, as well as, an objectively evaluation of the main behaviours in the middle of intervention. Investigators will inform about the relevance of attending the full process and respecting the condition and rule as control. Participants from the control group will be freely offered the possibility to get involve in a similar intervention protocol at the end of the study in order to benefit from the potential positive effect of exercise.

Supervised exercise programme

Experimental group

Description:

5 months of supervised physical exercise program. The individualized and progressive Health periodization model will be applied establishing an initial individualizing period, as well as identifying any need or adaptation to apply during the exercise program. The physical exercise program will be applied in a period of progressive increase whose initial objective will be to reach the volume and intensity established by the international recommendations of physical activity (http://www.health.gov/paguidelines/) for this population. Briefly, a volume of 150 min/week of moderate-vigorous physical activity (60% -85% reserve heart rate) spread over a maximum of 5 days and including force work 2-3 days/week. The training load will progressively increase with a wave and flexible periodization.

Treatment:

Behavioral: Supervised Exercise Programme