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| Name | Class |
|---|---|
| Instituto Mixto Universitario Deporte y Salud (iMUDS) | UNKNOWN |
| Research Center for Mind, Brain and Behavior, Spain | OTHER |
| University Hospital Virgen de las Nieves | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Wait-list control group | No Intervention | Control group will be asked to maintain their usual lifestyle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24-week resistance exercise program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Change in brain morphology |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in muscular strength | 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 |
| Change in physical function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Esteban-Cornejo, PhD | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Granada | Granada | Andalusia | 18016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37284481 | Background | 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. | |
| 37960912 |
| Label | URL |
|---|---|
| AGUEDA website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2024 | Mar 14, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| University of Pittsburgh |
| OTHER |
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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 |
| 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. | Baseline and 6 months |
| Change in white matter structure | MRI (magnetic resonance imaging) will measure white matter structure and lesions by diffusion weighted acquisition sequence. | Baseline and 6 months |
| 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. | Baseline and 6 months |
| Change in cerebral blood flow | MRI (magnetic resonance imaging) will measure cerebral blood flow by Pseudo-Continuous Arterial Spin Labeling (pCASL) sequence. | Baseline and 6 months |
| Change in peripheral amyloid beta | Saliva and blood samples will be used to determine peripheral amyloid beta | Baseline and 6 months |
| 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). | Baseline and 6 months |
| 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). | Baseline and 6 months |
| 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). | Baseline and 6 months |
| 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. | Baseline and 6 months |
| Change in other cognitive outcomes | Vocabulary/language, and subjective and objective cognitive decline will be assessed by paper-based tests. | Baseline 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 |
| Change in gait speed and variability | Gait analysis will be assessed by the OptoGait System | Baseline and 6 months |
| Change in cardiorespiratory fitness | 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 |
| Change in mental health outcomes, specifically psychological ill-being | A battery of questionnaire will assess psychological ill-being (i.e. depression, anxiety, stress or negative affect). | Baseline and 6 months |
| Change in mental health outcomes, specifically psychological well-being. | 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 |
| Change in quality of life | This will be self-reported using the Health Survey Short Form (SF-36). | Baseline and 6 months |
| Change in 24-hours movement behaviors | 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 |
| Change in sedentary behaviors | Type of sedentary behaviors will be self-reported by questionnaire. | Baseline and 6 months |
| Change in diet behaviors | This will be self-reported using the food-frequency questionnaire (FFQ) and the PREDIMED-14 questionnaire. | Baseline and 6 months |
| Change in body composition | 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 |
| Change in neck adipose tissue | Neck adipose tissue will be assessed by MRI | Baseline and 6 months |
| Change in blood pressure | Systolic and diastolic blood pressure will be assessed by a blood pressure monitor | Baseline and 6 months |
| Change in peripheral inflammatory and cardiovascular biomarkers | 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 |
| Change in epigenetics and gene expression | Blood samples will be stored for genetic analyses, including APOE and BDNF genotypes | Baseline and 6 months |
| Change in oral and gut microbiota | 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 |
| Background |
| 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. |
| 38007656 | Background | 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. |
| 37558161 | Background | 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. |
| 41967036 | Derived | 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. |
| 41562376 | Derived | 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. |
| 39425451 | Derived | 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. |