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HealthyAGUEDANCT05186090

Active Gains in Brain Using Exercise During Aging

A study testing 24-week resistance exercise program in people with Healthy and Cognitive Function 1, Social, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Cognitive Function 1, Social
What is being tested?
24-week resistance exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSpain
Study dates
2 Jan 2021to 11 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • Ambulatory with pain or regular use of an assisted walking device.
  • Medical contraindication for inclusion in an exercise program.
  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University of Granada

    Granada, Andalusia, 18016

Other trials in Spain

About this study

Official title: Active Gains in Brain Using Exercise During Aging: AGUEDA Trial

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.

Read the detailed description

Exercise has emerged as the most promising non-pharmacologic intervention for improving brain health in older adults. The main aim of AGUEDA (Active Gains in brain using Exercise During Aging) trial is to examine the effects of a 6-month resistance exercise program on executive function in cognitively normal older adults. The secondary aims are (i) to examine the effects of exercise on central and peripheral brain markers, and (ii) to investigate mediators and moderators of the exercise-derived improvements observed in executive function and brain markers. AGUEDA is a randomized controlled trial in which 90 cognitively normal older adults, aged 65-80 years old, will be randomized into an exercise group (n=45) or a wait-list control group (n=45). Participants assigned to the exercise group will participate in a 24-week resistance exercise program (3 sessions/week, 60 min/session), while the control group will be asked to maintain their usual lifestyle. A comprehensive neuropsychological test battery, amyloid PET scan, cutting-edge MRI scan, DXA scan, physical fitness, physical function and physical activity measures will be used. Blood, saliva and fecal samples will be collected. Mental health and psychosocial variables will be self-reported.

Being tested
24-week resistance exercise program
Keywords
brain, cognition, executive function, exercise, brain-gut axis, positron emission tomography, magnetic resonance imaging, aging, preclinical Alzheimer Disease stages
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 24-week resistance exercise programBehavioural

    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.

Study groups in NCT05186090
Study groupRoleWhat they receive
24-week resistance exercise programExperimentalParticipants will engage in supervised 24-week resistance exercise program with goal of maintaining 180 minutes of exercise per week.
Receives: Behavioral: 24-week resistance exercise program
Wait-list control groupNo interventionControl group will be asked to maintain their usual lifestyle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 3 months and 6 months

Secondary outcomes (12)
  1. Change in brain amyloid beta

    PET (positron emission tomography) scan using the tracer Neuraceq (Florbetaben F18) will measure levels of the protein amyloid beta in the brain.

    Measured: Baseline and 6 months

  2. Change in brain morphology

    MRI (magnetic resonance imaging) will measure brain morphology including volume, area, cortical thickness and shapes by a T1-weighted MPRAGE structural sequence.

    Measured: Baseline and 6 months

  3. Change in hippocampal brain morphology

    MRI (magnetic resonance imaging) will measure hippocampal morphology including volume, area, cortical thickness, shapes by a high resolution hippocampus sequence.

    Measured: Baseline and 6 months

  4. Change in white matter structure

    MRI (magnetic resonance imaging) will measure white matter structure and lesions by diffusion weighted acquisition sequence.

    Measured: Baseline and 6 months

  5. Change in brain function

    MRI (magnetic resonance imaging) will measure brain function including both resting state and n-back working memory task-evoked patterns. Measures of brain activity and brain connectivity will be calculated.

    Measured: Baseline and 6 months

  6. Change in cerebral blood flow

    MRI (magnetic resonance imaging) will measure cerebral blood flow by Pseudo-Continuous Arterial Spin Labeling (pCASL) sequence.

    Measured: Baseline and 6 months

  7. Change in peripheral amyloid beta

    Saliva and blood samples will be used to determine peripheral amyloid beta

    Measured: Baseline and 6 months

  8. Change in other peripheral neurology biomarkers

    Saliva and blood samples will be used to determine peripheral neurology biomarkers including brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VEGF) and cathepsin B (CTSB).

    Measured: Baseline and 6 months

  9. Change in memory performance

    Visuospatial memory will be assessed by the Rey-Osterreith figure (ROF) test, verbal memory by the Rey Auditory Verbal Learning Test (RAVLT) and confrontational word memory by the boston Naming Test (short version, BNT).

    Measured: Baseline and 6 months

  10. Change in fluid and crystallized intelligence

    Intelligence will be assessed by the Wechsler Adult Intelligence Scale (WAIS-IV). 3 subtests for crystallized intelligence (Similarities, Vocabulary, information) and 3 subtests for fluid intelligence (Block Design, Matrix Reasoning, Visual Puzzles).

    Measured: Baseline and 6 months

  11. Change in general cognition

    General cognition will be assessed by the Telephone Interview for Cognitive Status (STICS-m), the Mini mental state examination (MMSE) and the Montreal Cognitive Assessment (MOCA. vocabulary/language and subjective and objective cognitive decline will be assessed by paper-based tests.

    Measured: Baseline and 6 months

  12. Change in other cognitive outcomes

    Vocabulary/language, and subjective and objective cognitive decline will be assessed by paper-based tests.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start2 Jan 2021
  3. Primary completion11 Dec 2022
  4. Study completion11 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05186090
Sponsor's protocol ID
RTI2018-095284-J-I00
Acronym
AGUEDA
Status last verified
Sep 2026
First submitted
17 Oct 2021
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37284481
  • 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.

    PubMed 37960912
  • 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.

    PubMed 38007656
  • 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.

    PubMed 37558161
  • Fernandez-Gamez B, Solis-Urra P, Sanchez-Martinez J, Sclafani A, Olvera-Rojas M, Rodriguez-Palacios MT, Mellow ML, Dumuid D, Smith AE, Ortega FB, Esteban-Cornejo I. Microstructural Brain Reserve Moderates the Associations Between 24-h Movement Behaviors and Cognition in Older Adults: Cross-Sectional Findings From the AGUEDA Trial. Scand J Med Sci Sports. 2026 Sep;36(9):e70360. doi: 10.1111/sms.70360.

    PubMed 42701867
  • Sanchez-Martinez J, Solis-Urra P, Fernandez-Gamez B, Fernandez-Ortega J, Sanchez-Aranda L, Erickson KI, Ortega FB, Esteban-Cornejo I. Effects of a 24-week resistance exercise program on Alzheimer's disease brain signatures in cognitively unimpaired older adults: a secondary analysis of the AGUEDA randomized controlled trial. Age Ageing. 2026 Apr 4;55(4):afag086. doi: 10.1093/ageing/afag086.

    PubMed 41967036
  • 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.

    PubMed 41562376
  • 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.

    PubMed 39425451

Questions about this trial

What is this clinical trial studying?

A study testing 24-week resistance exercise program in people with Healthy and Cognitive Function 1, Social, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in executive function (time frame: Baseline, 3 months and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05186090, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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