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Completed

NCT Number: NCT05186090

Active Gains in Brain Using Exercise During Aging

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.

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Key information

Conditions

Healthy Behavior Cognitive Function 1, Social Motor Activity

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, Andalusia, 18016, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in executive function

    Time frame: 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.

Secondary outcomes

  1. Change in brain amyloid beta

    Time frame: 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.

  2. Change in brain morphology

    Time frame: 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.

  3. Change in hippocampal brain morphology

    Time frame: Baseline and 6 months

    MRI (magnetic resonance imaging) will measure hippocampal morphology including volume, area, cortical thickness, shapes by a high resolution hippocampus sequence.

  4. Change in white matter structure

    Time frame: Baseline and 6 months

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

  5. Change in brain function

    Time frame: 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.

  6. Change in cerebral blood flow

    Time frame: Baseline and 6 months

    MRI (magnetic resonance imaging) will measure cerebral blood flow by Pseudo-Continuous Arterial Spin Labeling (pCASL) sequence.

  7. Change in peripheral amyloid beta

    Time frame: Baseline and 6 months

    Saliva and blood samples will be used to determine peripheral amyloid beta

  8. Change in other peripheral neurology biomarkers

    Time frame: 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).

  9. Change in memory performance

    Time frame: 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).

  10. Change in fluid and crystallized intelligence

    Time frame: 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).

  11. Change in general cognition

    Time frame: 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.

  12. Change in other cognitive outcomes

    Time frame: Baseline and 6 months

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

Other outcomes

  1. Changes in muscular strength

    Time frame: 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

  2. Change in physical function

    Time frame: 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.

  3. Change in gait speed and variability

    Time frame: Baseline and 6 months

    Gait analysis will be assessed by the OptoGait System

  4. Change in cardiorespiratory fitness

    Time frame: 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)

  5. Change in mental health outcomes, specifically psychological ill-being

    Time frame: Baseline and 6 months

    A battery of questionnaire will assess psychological ill-being (i.e. depression, anxiety, stress or negative affect).

  6. Change in mental health outcomes, specifically psychological well-being.

    Time frame: 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).

  7. Change in quality of life

    Time frame: Baseline and 6 months

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

  8. Change in 24-hours movement behaviors

    Time frame: 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

  9. Change in sedentary behaviors

    Time frame: Baseline and 6 months

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

  10. Change in diet behaviors

    Time frame: Baseline and 6 months

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

  11. Change in body composition

    Time frame: 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.

  12. Change in neck adipose tissue

    Time frame: Baseline and 6 months

    Neck adipose tissue will be assessed by MRI

  13. Change in blood pressure

    Time frame: Baseline and 6 months

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

  14. Change in peripheral inflammatory and cardiovascular biomarkers

    Time frame: 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

  15. Change in epigenetics and gene expression

    Time frame: Baseline and 6 months

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

  16. Change in oral and gut microbiota

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Instituto Mixto Universitario Deporte y Salud (iMUDS)
  • Research Center for Mind, Brain and Behavior, Spain
  • University Hospital Virgen de las Nieves
  • University of Pittsburgh

Registry information

Official study title

Active Gains in Brain Using Exercise During Aging: AGUEDA Trial

Acronym: AGUEDA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2022
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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