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Ganancias activas en el cerebro usando ejercicio durante el envejecimiento (AGUEDA)

20 de septiembre de 2026 actualizado por: Irene Esteban-Cornejo, Universidad de Granada

Ganancias activas en el cerebro mediante el ejercicio durante el envejecimiento: ensayo 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.

Descripción general del estudio

Estado

Terminado

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Andalusia
      • Granada, Andalusia, España, 18016
        • University of Granada

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años a 80 años (Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Sin intervención: Wait-list control group

Control group will be asked to maintain their usual lifestyle.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in executive function
Periodo de tiempo: Baseline, 3 months and 6 months

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in brain amyloid beta
Periodo de tiempo: 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
Change in brain morphology
Periodo de tiempo: 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
Change in hippocampal brain morphology
Periodo de tiempo: 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
Change in white matter structure
Periodo de tiempo: Baseline and 6 months

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

Baseline and 6 months
Change in brain function
Periodo de tiempo: 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
Change in cerebral blood flow
Periodo de tiempo: 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
Change in peripheral amyloid beta
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Change in general cognition
Periodo de tiempo: 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
Change in other cognitive outcomes
Periodo de tiempo: Baseline and 6 months

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

Baseline and 6 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in muscular strength
Periodo de tiempo: 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
Change in physical function
Periodo de tiempo: 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
Change in gait speed and variability
Periodo de tiempo: Baseline and 6 months

Gait analysis will be assessed by the OptoGait System

Baseline and 6 months
Change in cardiorespiratory fitness
Periodo de tiempo: Baseline and 6 months

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
Periodo de tiempo: Baseline and 6 months

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.
Periodo de tiempo: 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
Change in quality of life
Periodo de tiempo: Baseline and 6 months

This will be self-reported using the Health Survey Short Form (SF-36).

Baseline and 6 months
Change in 24-hours movement behaviors
Periodo de tiempo: 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
Change in sedentary behaviors
Periodo de tiempo: Baseline and 6 months

Type of sedentary behaviors will be self-reported by questionnaire.

Baseline and 6 months
Change in diet behaviors
Periodo de tiempo: Baseline and 6 months

This will be self-reported using the food-frequency questionnaire (FFQ) and the PREDIMED-14 questionnaire.

Baseline and 6 months
Change in body composition
Periodo de tiempo: 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
Change in neck adipose tissue
Periodo de tiempo: Baseline and 6 months

Neck adipose tissue will be assessed by MRI

Baseline and 6 months
Change in blood pressure
Periodo de tiempo: Baseline and 6 months

Systolic and diastolic blood pressure will be assessed by a blood pressure monitor

Baseline and 6 months
Change in peripheral inflammatory and cardiovascular biomarkers
Periodo de tiempo: 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
Change in epigenetics and gene expression
Periodo de tiempo: Baseline and 6 months

Blood samples will be stored for genetic analyses, including APOE and BDNF genotypes

Baseline and 6 months
Change in oral and gut microbiota
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Irene Esteban-Cornejo, PhD, Universidad de Granada

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de enero de 2021

Finalización primaria (Actual)

11 de diciembre de 2022

Finalización del estudio (Actual)

11 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

17 de octubre de 2021

Primero enviado que cumplió con los criterios de control de calidad

22 de diciembre de 2021

Publicado por primera vez (Actual)

11 de enero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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