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Ganhos ativos no cérebro usando exercícios durante o envelhecimento (AGUEDA)

20 de setembro de 2026 atualizado por: Irene Esteban-Cornejo, Universidad de Granada

Ganhos ativos no cérebro usando exercícios durante o envelhecimento: ensaio 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

90

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Andalusia
      • Granada, Andalusia, Espanha, 18016
        • University of Granada

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

65 anos a 80 anos (Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.

Sem intervenção: Wait-list control group

Control group will be asked to maintain their usual lifestyle.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in executive function
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in brain amyloid beta
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and 6 months

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

Baseline and 6 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Changes in muscular strength
Prazo: 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
Prazo: 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
Prazo: Baseline and 6 months

Gait analysis will be assessed by the OptoGait System

Baseline and 6 months
Change in cardiorespiratory fitness
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and 6 months

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

Baseline and 6 months
Change in diet behaviors
Prazo: 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
Prazo: 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
Prazo: Baseline and 6 months

Neck adipose tissue will be assessed by MRI

Baseline and 6 months
Change in blood pressure
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de janeiro de 2021

Conclusão Primária (Real)

11 de dezembro de 2022

Conclusão do estudo (Real)

11 de dezembro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

17 de outubro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de dezembro de 2021

Primeira postagem (Real)

11 de janeiro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

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NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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