Clinical trial NCT05186090: Active Gains in Brain Using Exercise During Aging
Official title: Active Gains in Brain Using Exercise During Aging: AGUEDA Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Cognitive Function 1, Social
Keywords: brain
cognition
executive function
exercise
brain-gut axis
positron emission tomography
magnetic resonance imaging
aging
preclinical Alzheimer Disease stages
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Instituto Mixto Universitario Deporte y Salud (iMUDS)
name: Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC)
name: University Hospital Virgen de las Nieves
name: University of Pittsburgh
First posted: 2022-01-11
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in executive function
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Change in brain amyloid beta
timeFrame: Baseline and 6 months
measure: Change in brain morphology
timeFrame: Baseline and 6 months
measure: Change in hippocampal brain morphology
timeFrame: Baseline and 6 months
measure: Change in white matter structure
timeFrame: Baseline and 6 months
measure: Change in brain function
timeFrame: Baseline and 6 months
measure: Change in cerebral blood flow
timeFrame: Baseline and 6 months
measure: Change in peripheral amyloid beta
timeFrame: Baseline and 6 months
measure: Change in other peripheral neurology biomarkers
timeFrame: Baseline and 6 months
measure: Change in memory performance
timeFrame: Baseline and 6 months
measure: Change in fluid and crystallized intelligence
timeFrame: Baseline and 6 months
measure: Change in general cognition
timeFrame: Baseline and 6 months
measure: Change in other cognitive outcomes
timeFrame: Baseline and 6 months
Other outcomes:
measure: Changes in muscular strength
timeFrame: Baseline, 3 months (only for field-based tests) and 6 months
measure: Change in physical function
timeFrame: Baseline, 3 months and 6 months
measure: Change in gait speed and variability
timeFrame: Baseline and 6 months
measure: Change in cardiorespiratory fitness
timeFrame: Baseline and 6 months
measure: Change in mental health outcomes, specifically psychological ill-being
timeFrame: Baseline and 6 months
measure: Change in mental health outcomes, specifically psychological well-being.
timeFrame: Baseline and 6 months
measure: Change in quality of life
timeFrame: Baseline and 6 months
measure: Change in 24-hours movement behaviors
timeFrame: Baseline and 3 months
measure: Change in sedentary behaviors
timeFrame: Baseline and 6 months
measure: Change in diet behaviors
timeFrame: Baseline and 6 months
measure: Change in body composition
timeFrame: Baseline and 6 months
measure: Change in neck adipose tissue
timeFrame: Baseline and 6 months
measure: Change in blood pressure
timeFrame: Baseline and 6 months
measure: Change in peripheral inflammatory and cardiovascular biomarkers
timeFrame: Baseline and 6 months
measure: Change in epigenetics and gene expression
timeFrame: Baseline and 6 months
measure: Change in oral and gut microbiota
timeFrame: Baseline and 6 months
Locations:
city: Granada
country: Spain
facility: University of Granada
state: Andalucia
Study officials:
affiliation: Universidad de Granada
name: Irene Esteban-Cornejo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.