Understanding Cerebral Blood Flow Dynamics for Alzheimer's Disease Prevention Through Exercise
flADex
1 other identifier
interventional
20
1 country
2
Brief Summary
Dementia is one of the leading causes of disability worldwide. Underlying biological mechanisms are crucial in preclinical stages of Alzheimer's disease (AD). Alterations in cerebral blood flow (CBF) and their relationship with AD blood-based biomarkers may be fundamental at early stages of the pathology. Physical exercise is a trigger to modify these biological mechanisms. Therefore, flADex aims to examine the acute effects of different types of exercise (resistance vs. aerobic vs. control) on CBF, AD blood-based biomarkers, and its cognitive implications in older adults. The hypothesis is that acute resistance or aerobic exercise will fluctuate levels of blood-based biomarkers, and will exert acute CBF changes combined with cognitive implications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
September 5, 2024
CompletedStudy Start
First participant enrolled
September 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2025
CompletedMarch 25, 2025
March 1, 2025
3 months
August 6, 2024
March 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cerebral Blood Flow (CBF)
Specific acquisition parameters for Pseudo continuous Arterial Spin Labeling (pCASL) sequence are used to determinate global and regional CBF in resting condition. Structural T1 sequence (only pre-condition) is used to coregisted the pCASL and delineate regions of interest for CBF. Time-of-flight angiography (TOF) (before pCASL pre-condition and before first pCASL post-condition) sequence is used to identify the carotid arteries. The unit of measurement of the CBF is expressed as milliliters per 100 grams of brain tissue per minute (mL/100 g/min).
30 minutes before the experimental condition; and 20 minutes, 27 minutes and 34 minutes minutes after the experimental condition
Secondary Outcomes (8)
Change in Alzheimer disease blood-based biomarkers (Aβ42/40 ratio)
5 minutes before the experimental condition; and 0 minutes, 50 minutes and 70 minutes after the experimental condition
Change in Alzheimer disease blood-based biomarkers (p-tau217, p-tau181, NfL and GFAP)
5 minutes before the experimental condition; and 0 minutes, 50 minutes and 70 minutes after the experimental condition
Change in growth factors (BDNF)
5 minutes before the experimental condition; and 0 minutes, 50 minutes and 70 minutes after the experimental condition
Change in growth factors (IGF-1)
5 minutes before the experimental condition; and 0 minutes, 50 minutes and 70 minutes after the experimental condition
Change in episodic memory
15 minutes before the experimental condition; and 60 minutes after the experimental condition
- +3 more secondary outcomes
Other Outcomes (4)
Enjoyment
5 minutes after the experimental condition
Physical engagement (in aerobic condition and resistance condition)
During the experimental condition at minute 12, minute 20, and minute 30
Repetitions in reserve (in resistance condition)
During the resistance condition after each exercise at minutes 5, 6, 7, 8, 9, 10, 11, 12 / 14, 15, 16, 17, 18, 19, 20, 21 / 23, 24, 25, 26, 27, 28, 29, 30
- +1 more other outcomes
Study Arms (3)
Aerobic exercise group
EXPERIMENTAL-Aerobic group. 30 min at 60-70% of the Maximal Heart Rate, moderate intensity on cycle.
Resistance exercise group
EXPERIMENTAL30 min at 4-6 RPE (OMNI-Resistance Exercise Scale of Perceived Exertion), 3 sets of 8 exercise/set, 40 sec/exercise. Moderate intensity using elastic bands and body weight.
Control
NO INTERVENTION30 min seated watching a neutral documentary without cognitive engagement
Interventions
Aerobic session will last 30 min. The average intensity of the aerobic sessions will be 60-70% of the Maximal Heart Rate. Therefore, participant will perform a continuous moderate intensity aerobic bout of exercise on a cycle ergometer.
Resistance exercise will last 30 min at 4-6 RPE (OMNI-Resistance Exercise Scale of Perceived Exertion from 0-10). The bout of resistance exercise will include a combination of upper and lower body exercises using elastic bands and the participants' body weight as the primary resistance. Eight different exercises will be performed per set, with 40 seconds per exercise, for a total of 3 sets. The exercises are based on basic movement patterns and include: glute bridge, front plank, standing face pull, incline push-up, squat, pallof press, walking lunge and seated shoulder press.
Eligibility Criteria
You may qualify if:
- Older adults
- Aged 68-83 years
- Non-pathological cerebral beta-amyloid status (based on Centiloid cut-point \<12 measured by PET-CT)
- APOEe4 negative status
- Willingness to participate in exercise interventions
You may not qualify if:
- Pathological diagnosis related to physical or mental condition
- No living in community settings during the study
- MRI incompatibility
- Ambulatory with pain or regular use of an assisted walking device
- Severe cardiovascular or respiratory conditions
- Participation in another clinical trial within the last 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Granada
Granada, Andalusia, 18016, Spain
Mind, Brain, and Behaviour Research Centre (CIMCYC, Centro de Investigación Mente, Cerebro y Comportamiento)
Granada, 18011, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irene Esteban-Cornejo, PhD
Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Spain.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ramon y Cajal Assistant Professor, PhD
Study Record Dates
First Submitted
August 6, 2024
First Posted
September 5, 2024
Study Start
September 25, 2024
Primary Completion
January 2, 2025
Study Completion
January 2, 2025
Last Updated
March 25, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- The IPD data will be available 12 months after the primary outcome paper published. The data will be available 15 years after data collection.
- Access Criteria
- The specific process of data access will be determined in a later stage, but in general the research team supports data sharing. Roughly, data will be available upon reasonable request to the PI (Irene Esteban-Cornejo). The data requests must contain the purpose and aim of the research, but also specification of the data requested, and data analysis before data sharing. Data will only be shared for research purposes on exercise and brain health. In addition, we will follow \"as open as possible, as closed as necessary\" principle, so depending on this principle we will decide whether the data could be shared. A data access committee will be installed to approve data requests.
The protocol, statistical analyses plan and data management plan will be sharing open access. Data files including IPD, and corresponding data dictionaries, will be shared under restricted access and upon reasonable request (contact Irene Esteban-Cornejo) due to privacy issue and GDPR regulations. In principle, all collected IPD will be available for sharing under the \"as open as possible, as closed as necessary\" principle. The shared data files will be pseudonymized, only include participants who provided informed consent for sharing, and sharing is only possible when the data is used for research purposes regarding exercise, and brain health. This is stated at the informed consent files that the participants signed when they agree to participate.