NCT03923712

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

Completed NA Last updated 27 April 2021

What this trial tests

NA trial testing Supervised Exercise Programme in Mild Cognitive Impairment in 98 participants. Completed in 31 December 2020.

Timeline

15 January 2018

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	University of Cadiz
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	98
Start date	15 January 2018
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across Spain

Drugs / interventions tested

• Supervised Exercise Programme

Conditions studied

• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Alzheimer Dementia — all drugs for Alzheimer Dementia →

Sponsor

University of Cadiz

Who can join

Adults 65 to 75, any sex, with Mild Cognitive Impairment or Alzheimer Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A new set of estimated cardiorespiratory fitness equations are associated with cognitive performance in older adults.
   Velázquez-Díaz D, Cadenas-Sanchez C, Molina-Guzmán FA, Sáenz-Carrasco JA, et al · · 2023 · cited 2× · PMID 36653578 · DOI 10.1007/s11357-022-00718-w