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

NCT03923712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-04-27

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Supervised Exercise Programme

The methodology will be multicomponent, including aerobic, strength, coordination-cognitive and balance-agility. The physical exercise sessions will be designed in such a way that they work the dimensions but being attractive and motivating for the participants. Each session will include 10 minutes of warm-up with smooth running and mobility exercises; 35-40 minutes of aerobic, strength, coordination-cognitive and balance-agility progressively developed; and 10 minutes back to calm at low intensity with stretching exercises. Nutritional intervention will not be included. For quality purposes, we will use small groups (10-15 pers). After each session participants will be asked about their subjective perception of the effort and the intensity will be controlled by heart rate monitors.

Sponsors & Collaborators

  • Centro de Excelencia en Metabolómica y Bioanálisis (CEMBIO)

    collaborator UNKNOWN
  • Servicio Central de Neuroimagen de la Universidad Pablo de Olavide

    collaborator UNKNOWN
  • Consejería de Salud y Bienestar Social, Andalucía

    collaborator UNKNOWN
  • University of Cadiz

    lead OTHER

Principal Investigators

  • David Jiménez Pavón, PhD · University of Cádiz

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03923712 on ClinicalTrials.gov