NCT05186090

Brief Summary

AGUEDA (Active Gains in brain using Exercise During Aging) is a randomized controlled trial designed to examine the effects of a 24-week resistance exercise program on brain health in cognitively normal adults between 65-80 years of age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

January 2, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2022

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

October 17, 2021

Last Update Submit

March 14, 2024

Conditions

HealthyCognitive Function 1, Social

Keywords

braincognitionexecutive functionexercisebrain-gut axispositron emission tomographymagnetic resonance imagingagingpreclinical Alzheimer Disease stages

Outcome Measures

Primary Outcomes (1)

  • Change in executive function

    The main outcome is change in executive function from baseline to 6 months. The 3-month measure is used to assess the trajectory of the change. A comprehensive neuropsychological battery will assess several domains of executive function: working memory, cognitive flexibility and inhibitory control.

    Baseline, 3 months and 6 months

Secondary Outcomes (12)

  • Change in brain amyloid beta

    Baseline and 6 months

  • Change in brain morphology

    Baseline and 6 months

  • Change in hippocampal brain morphology

    Baseline and 6 months

  • Change in white matter structure

    Baseline and 6 months

  • Change in brain function

    Baseline and 6 months

  • +7 more secondary outcomes

Other Outcomes (16)

  • Changes in muscular strength

    Baseline, 3 months (only for field-based tests) and 6 months

  • Change in physical function

    Baseline, 3 months and 6 months

  • Change in gait speed and variability

    Baseline and 6 months

  • +13 more other outcomes

Study Arms (2)

24-week resistance exercise program

EXPERIMENTAL

Participants will engage in supervised 24-week resistance exercise program with goal of maintaining 180 minutes of exercise per week.

Behavioral: 24-week resistance exercise program

Wait-list control group

NO INTERVENTION

Control group will be asked to maintain their usual lifestyle.

Interventions

24-week resistance exercise programBEHAVIORAL

This group will perform a 24-week resistance exercise program. Participants will engage in 180 minutes/week of resistance exercise (3 supervised sessions peer week, 60 min/session). The training will consist of a combination of upper and lower body exercises using elastic bands and participants' body weight as the primary resistance. Exercise load and intensity will be based on the number of repetitions (i.e.,10-12 repetitions), resistance of the elastic bands, in ascending order with seven intensities, and also on the exercises' difficulty (i.e., three levels). The prescribed targeted intensity will reach 70-80% of the participants' maximum rating perceived exertion (i.e., 7-8 RPE).The progression (horizontal) will be standardized according to the execution time and RPE, and individualized according to execution speed and band resistance. Heart rate will be monitored in all sessions. Further, intrinsic motivation before and after session and sleep quality will be registered.

24-week resistance exercise program

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women 65 - 80 years.
  • Able to speak and read fluent Spanish.
  • Living in community during the study.
  • Reliable means of transportation.
  • Being physical inactive (i.e., not to be participating in the last 6 months in any resistance exercise program, or accumulating less than 600 METS/Week of moderate-vigorous physical activity).
  • Classified as cognitively normal according to Stics-m MMSE and MOCA tests.

You may not qualify if:

  • Ambulatory with pain or regular use of an assisted walking device.
  • Neurological condition (Multiple Sclerosis, Parkinson Disease, Dementia) or brain injury (traumatic or stroke).
  • Current diagnosis and treatment of a DSM-V Axis I or II disorder including major depression and seeing a psychologist, therapist, or psychiatrist.
  • History of major psychiatric illness including schizophrenia, general anxiety disorder or depression (GDS-30\>=15).
  • Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep venous thrombosis or other cardiovascular event.
  • Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year.
  • Current or previous treatment for any type of cancer.
  • Type I Diabetes or uncontrolled Type II Diabetes defined as Insulin dependent or Hba1C greater than 10.
  • Recent treatment for alcohol or substance abuse.
  • Presence of metal implants (e.g., pacemaker, stents, joint replacement) that would be MRI ineligible.
  • Claustrophobia.
  • Color blindness.
  • Diagnosis of COVID-19 with hospitalization in intensive care unit.
  • Any other consideration that interferes with the study aims and could be a risk to the participant, at the discretion of the researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, Andalusia, 18016, Spain

Location

Related Publications (6)

  • Solis-Urra P, Molina-Hidalgo C, Garcia-Rivero Y, Costa-Rodriguez C, Mora-Gonzalez J, Fernandez-Gamez B, Olvera-Rojas M, Coca-Pulido A, Toval A, Bellon D, Sclafani A, Martin-Fuentes I, Trivino-Ibanez EM, de Teresa C, Huang H, Grove G, Hillman CH, Kramer AF, Catena A, Ortega FB, Gomez-Rio M, Erickson KI, Esteban-Cornejo I. Active Gains in brain Using Exercise During Aging (AGUEDA): protocol for a randomized controlled trial. Front Hum Neurosci. 2023 May 22;17:1168549. doi: 10.3389/fnhum.2023.1168549. eCollection 2023.

    PMID: 37284481BACKGROUND

  • Fernandez-Gamez B, Solis-Urra P, Olvera-Rojas M, Molina-Hidalgo C, Fernandez-Ortega J, Lara CP, Coca-Pulido A, Bellon D, Sclafani A, Mora-Gonzalez J, Toval A, Martin-Fuentes I, Bakker EA, Lozano RM, Navarrete S, Jimenez-Pavon D, Liu-Ambrose T, Erickson KI, Ortega FB, Esteban-Cornejo I. Resistance Exercise Program in Cognitively Normal Older Adults: CERT-Based Exercise Protocol of the AGUEDA Randomized Controlled Trial. J Nutr Health Aging. 2023;27(10):885-893. doi: 10.1007/s12603-023-1982-1.

    PMID: 37960912BACKGROUND

  • Solis-Urra P, Rodriguez-Ayllon M, Alvarez-Ortega M, Molina-Hidalgo C, Molina-Garcia P, Arroyo-Avila C, Garcia-Hermoso A, Collins AM, Jain S, Gispert JD, Liu-Ambrose T, Ortega FB, Erickson KI, Esteban-Cornejo I. Physical Performance and Amyloid-beta in Humans: A Systematic Review and Meta-Analysis of Observational Studies. J Alzheimers Dis. 2023;96(4):1427-1439. doi: 10.3233/JAD-230586.

    PMID: 38007656BACKGROUND

  • Rodriguez-Ayllon M, Solis-Urra P, Arroyo-Avila C, Alvarez-Ortega M, Molina-Garcia P, Molina-Hidalgo C, Gomez-Rio M, Brown B, Erickson KI, Esteban-Cornejo I. Physical activity and amyloid beta in middle-aged and older adults: A systematic review and meta-analysis. J Sport Health Sci. 2024 Mar;13(2):133-144. doi: 10.1016/j.jshs.2023.08.001. Epub 2023 Aug 7.

    PMID: 37558161BACKGROUND

  • Fernandez-Gamez B, Solis-Urra P, Coca-Pulido A, Molina-Hidalgo C, Olvera-Rojas M, Bakker EA, Bellon D, Sclafani A, Mora-Gonzalez J, Fernandez-Ortega J, Sanchez-Aranda L, Martin-Fuentes I, Toval A, Sanchez-Martinez J, Wan L, Gomez-Rio M, Liu-Ambrose T, Erickson KI, Ortega FB, Esteban-Cornejo I. Effect of a 24-week resistance exercise intervention on cognitive function in cognitively normal older adults: The AGUEDA randomized controlled trial. Alzheimers Dement. 2026 Jan;22(1):e71019. doi: 10.1002/alz.71019.

    PMID: 41562376DERIVED

  • Coca-Pulido A, Solis-Urra P, Fernandez-Gamez B, Olvera-Rojas M, Bellon D, Sclafani A, Toval A, Martin-Fuentes I, Bakker EA, Fernandez-Ortega J, Gomez-Rio M, Hillman CH, Erickson KI, Ortega FB, Mora-Gonzalez J, Esteban-Cornejo I. Fitness, Gray Matter Volume, and Executive Function in Cognitively Normal Older Adults: Cross-Sectional Findings From the AGUEDA Trial. Scand J Med Sci Sports. 2024 Oct;34(10):e14746. doi: 10.1111/sms.14746.

    PMID: 39425451DERIVED

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Irene Esteban-Cornejo, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2021

First Posted

January 11, 2022

Study Start

January 2, 2021

Primary Completion

December 11, 2022

Study Completion

December 11, 2022

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)