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Guadagni attivi nel cervello usando l'esercizio durante l'invecchiamento (AGUEDA)

20 settembre 2026 aggiornato da: Irene Esteban-Cornejo, Universidad de Granada

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

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

Interventistico

Iscrizione (Effettivo)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Andalusia
      • Granada, Andalusia, Spagna, 18016
        • University of Granada

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 65 anni a 80 anni (Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

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

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

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
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.

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
Change in executive function
Lasso di tempo: 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

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
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
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
Change in white matter structure
Lasso di tempo: 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
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
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
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
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
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
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
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
Change in gait speed and variability
Lasso di tempo: Baseline and 6 months

Gait analysis will be assessed by the OptoGait System

Baseline and 6 months
Change in cardiorespiratory fitness
Lasso di tempo: 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
Lasso di tempo: 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.
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
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
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
Change in sedentary behaviors
Lasso di tempo: Baseline and 6 months

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

Baseline and 6 months
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
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
Change in neck adipose tissue
Lasso di tempo: Baseline and 6 months

Neck adipose tissue will be assessed by MRI

Baseline and 6 months
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
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
Change in epigenetics and gene expression
Lasso di tempo: 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
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

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 gennaio 2021

Completamento primario (Effettivo)

11 dicembre 2022

Completamento dello studio (Effettivo)

11 dicembre 2022

Date di iscrizione allo studio

Primo inviato

17 ottobre 2021

Primo inviato che soddisfa i criteri di controllo qualità

22 dicembre 2021

Primo Inserito (Effettivo)

11 gennaio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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