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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Exercise (EXS) | All EXS sessions will be at a facility at the WUSTL medical campus. Sessions will be offered weekdays. Each session will start with range of motion EXS. Participants will follow an individualized EXS training prescription based on baseline cardiovascular testing. Individual aerobic EXS intensity is based on % of maximum HR achieved during the baseline cardiorespiratory fitness test. The target EXS HR will start at 50% and progress to 85% HR reserve. During aerobic exercise, a battery-operated HR monitor will monitor HR. Exercise intensity \& duration will be increased as the participant acclimates to the EXS prescription. Adaptation is determined when a given EXS intensity yields a lower HR than prior sessions conducted at the same intensity. Exercise: The resistance EXS training component will follow aerobic EXS and will consist of 4 upper and 3 lower body routines. A combination of guided-motion machines and free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each EXS station. The program will initially consist of 1-2 sets of each exercise while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's EXS response, and when the participant can comfortably lift the weight for 12 repetitions on any EXS, the weight will be increased to cause the muscle group to fatigue after 8 repetitions. This progressive 8-12 repetition cycle is repeated for each EXS over 26 weeks. | 0 | None | 0 | 45 | 0 | 45 | View |
| Social Interaction Stretching (SIS) | This group will serve as a control group against which to gauge the effects of aerobic and resistance training on cognitive function. Participants in this group will follow the same schedule and format as the EXS group. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. These SIS participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the EXS classes. Activities will focus on flexibility enhancement. As the participant's level of flexibility increases, stretches with increasing levels of difficulty will be incorporated into the program. Stretching and Social Interaction: Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. | 0 | None | 0 | 20 | 0 | 20 | View |