- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05186090
Guadagni attivi nel cervello usando l'esercizio durante l'invecchiamento (AGUEDA)
Guadagni attivi nel cervello usando l'esercizio durante l'invecchiamento: prova AGUEDA
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Andalusia
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Granada, Andalusia, Spagna, 18016
- University of Granada
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 24-week resistance exercise program
Participants will engage in supervised 24-week resistance exercise program with goal of maintaining 180 minutes of exercise per week. |
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. |
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Nessun intervento: Wait-list control group
Control group will be asked to maintain their usual lifestyle. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in executive function
Lasso di tempo: Baseline, 3 months and 6 months
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in brain amyloid beta
Lasso di tempo: Baseline and 6 months
|
PET (positron emission tomography) scan using the tracer Neuraceq (Florbetaben F18) will measure levels of the protein amyloid beta in the brain. |
Baseline and 6 months
|
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Change in brain morphology
Lasso di tempo: Baseline and 6 months
|
MRI (magnetic resonance imaging) will measure brain morphology including volume, area, cortical thickness and shapes by a T1-weighted MPRAGE structural sequence. |
Baseline and 6 months
|
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Change in hippocampal brain morphology
Lasso di tempo: Baseline and 6 months
|
MRI (magnetic resonance imaging) will measure hippocampal morphology including volume, area, cortical thickness, shapes by a high resolution hippocampus sequence. |
Baseline and 6 months
|
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Change in white matter structure
Lasso di tempo: Baseline and 6 months
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MRI (magnetic resonance imaging) will measure white matter structure and lesions by diffusion weighted acquisition sequence. |
Baseline and 6 months
|
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Change in brain function
Lasso di tempo: Baseline and 6 months
|
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. |
Baseline and 6 months
|
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Change in cerebral blood flow
Lasso di tempo: Baseline and 6 months
|
MRI (magnetic resonance imaging) will measure cerebral blood flow by Pseudo-Continuous Arterial Spin Labeling (pCASL) sequence. |
Baseline and 6 months
|
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Change in peripheral amyloid beta
Lasso di tempo: Baseline and 6 months
|
Saliva and blood samples will be used to determine peripheral amyloid beta |
Baseline and 6 months
|
|
Change in other peripheral neurology biomarkers
Lasso di tempo: Baseline and 6 months
|
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). |
Baseline and 6 months
|
|
Change in memory performance
Lasso di tempo: Baseline and 6 months
|
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). |
Baseline and 6 months
|
|
Change in fluid and crystallized intelligence
Lasso di tempo: Baseline and 6 months
|
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). |
Baseline and 6 months
|
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Change in general cognition
Lasso di tempo: Baseline and 6 months
|
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. |
Baseline and 6 months
|
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Change in other cognitive outcomes
Lasso di tempo: Baseline and 6 months
|
Vocabulary/language, and subjective and objective cognitive decline will be assessed by paper-based tests. |
Baseline and 6 months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Changes in muscular strength
Lasso di tempo: Baseline, 3 months (only for field-based tests) and 6 months
|
Muscular strength will be assessed by laboratory (i.e. isokinetic test) and field- based (i.e., handgrip and functional tests) tests |
Baseline, 3 months (only for field-based tests) and 6 months
|
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Change in physical function
Lasso di tempo: Baseline, 3 months and 6 months
|
Senior Fitness Test and Short Physical Performance Battery will assess overall physical functioning and z-scores will be calculated. |
Baseline, 3 months and 6 months
|
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Change in gait speed and variability
Lasso di tempo: Baseline and 6 months
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Gait analysis will be assessed by the OptoGait System |
Baseline and 6 months
|
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Change in cardiorespiratory fitness
Lasso di tempo: Baseline and 6 months
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Cardiorespiratory fitness will be assessed by 2 field-based tests ( i.e., 6-min walking test and 2-km walking test) |
Baseline and 6 months
|
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Change in mental health outcomes, specifically psychological ill-being
Lasso di tempo: Baseline and 6 months
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A battery of questionnaire will assess psychological ill-being (i.e. depression, anxiety, stress or negative affect). |
Baseline and 6 months
|
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Change in mental health outcomes, specifically psychological well-being.
Lasso di tempo: Baseline and 6 months
|
A battery of questionnaire will assess psychological well-being (i.e. self-esteem, self-concept, self-efficacy, self-image, positive affect, optimism, happiness and satisfaction with life). |
Baseline and 6 months
|
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Change in quality of life
Lasso di tempo: Baseline and 6 months
|
This will be self-reported using the Health Survey Short Form (SF-36). |
Baseline and 6 months
|
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Change in 24-hours movement behaviors
Lasso di tempo: Baseline and 3 months
|
Physical activity at different intensities (average min/day), sedentary time (average min/day) and sleep (average min/day) will be measured using Actigraph GT3X + accelerometers |
Baseline and 3 months
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Change in sedentary behaviors
Lasso di tempo: Baseline and 6 months
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Type of sedentary behaviors will be self-reported by questionnaire. |
Baseline and 6 months
|
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Change in diet behaviors
Lasso di tempo: Baseline and 6 months
|
This will be self-reported using the food-frequency questionnaire (FFQ) and the PREDIMED-14 questionnaire. |
Baseline and 6 months
|
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Change in body composition
Lasso di tempo: Baseline and 6 months
|
Body composition [i.e., lean mass (kg), fat mass (kg), and bone mineral content and density (z-score)] will be assessed using a dual-energy x-ray absorptiometer (DXA). Full- body, bilateral hips and lumbar spine scans will be acquired. |
Baseline and 6 months
|
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Change in neck adipose tissue
Lasso di tempo: Baseline and 6 months
|
Neck adipose tissue will be assessed by MRI |
Baseline and 6 months
|
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Change in blood pressure
Lasso di tempo: Baseline and 6 months
|
Systolic and diastolic blood pressure will be assessed by a blood pressure monitor |
Baseline and 6 months
|
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Change in peripheral inflammatory and cardiovascular biomarkers
Lasso di tempo: Baseline and 6 months
|
Saliva and blood samples will be used to determine peripheral biomarkers including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1beta), glucose, insulin, HDL and LDL cholesterol |
Baseline and 6 months
|
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Change in epigenetics and gene expression
Lasso di tempo: Baseline and 6 months
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Blood samples will be stored for genetic analyses, including APOE and BDNF genotypes |
Baseline and 6 months
|
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Change in oral and gut microbiota
Lasso di tempo: Baseline and 6 months
|
Saliva and fecal samples will be used to determine oral and gut microbiota including the most representative phyla (i.e., firmicutes, bacteroidetes, and proteobacteria. |
Baseline and 6 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Irene Esteban-Cornejo, PhD, Universidad de Granada
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RTI2018-095284-J-I00
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