Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 5:09 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT03114150
Description: None
Frequency Threshold: 0
Time Frame: The duration of enrollment for all participant, which includes from the time they signed informed consent until completion of their last post-intervention assessment. Typically this was 8 months.
Study: NCT03114150
Study Brief: Exercise Effects on Brain Health and Learning From Minutes to Months
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Moderate Intensity Aerobic Exercise Crossover condition of Moderate Intensity Aerobic Exercise preceding Light Intensity Aerobic Exercise for acute exercise manipulation 0 None 0 119 0 119 View
Light Intensity Aerobic Exercise Crossover condition of Light Intensity Aerobic Exercise preceding Moderate Intensity Aerobic Exercise for acute exercise manipulation 0 None 0 122 0 122 View
Cardiorespiratory Fitness Training Cardiorespiratory fitness training will be a 24-week supervised cycling program designed to improve cardiorespiratory fitness, with supervision directly from the research team. All participants will first receive a one-on-one orientation with an exercise training specialist that has been trained by Dr. Gary Pierce in monitoring an exercise program for healthy older adults. Training will start with a 5 minute-warm-up, 20 minutes moderate intensity cycling and 30 minutes light intensity cycling, and 5 minute cool-down per session, for 3 sessions/week. In each additional week, 6 minutes of moderate intensity cycling per session will be added, until the total time for moderate intensity is 50 minutes per session by the start of week 5 (with additional 5 minute warm-up and 5 minute cool-down). Cardiorespiratory fitness training: Physical exercise of moderate intensity designed to improve cardiorespiratory fitness 0 None 0 60 22 60 View
Functional Fitness Training Functional fitness training will be a 24-week supervised exercise program designed to focus on functional flexibility and mobility, with supervision directly from our research team. All participants will first receive a one-on-one orientation with an exercise training specialist that has been trained by Dr. Gary Pierce in monitoring an exercise program for healthy older adults. Training will start with a 5 minute-warm-up, 20 minutes of light intensity cycling and 20 minutes of dynamic stretching to increase range of motion and functional fitness, for 3 sessions/week. In each additional week, additional stretches will be added to maintain variety and improve flexibility of all major muscle groups. Functional fitness training: Physical exercise of light intensity designed to improve functional fitness 0 None 0 56 8 56 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain (knee, joint, hip) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heart abnormality at peak at fitness test SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Incidental finding in MRI SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Positive for COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View