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 |
|---|---|---|---|---|---|---|---|---|
| Indoor Treadmill Walking (T) | To ensure that all physical parameters were simultaneous to the outdoor mountain hiking condition, the distance, the difference in height, the average inclination of the track, and the time needed for the outdoor mountain hiking situation were measured in a pilot study. First part: uphill walking, inclination: 10%, time: 1.5 hours, and speed: 4 km/h (resulting in 600 m difference in height). In accordance to possible differences in outdoor speed, the participants were allowed to change the treadmill's speed in a small range (3.8 to 4.2 km/h) to adapt to the wording "brisk without overspending". Second part of the intervention contained 70 minutes of level walking on the same treadmills (5.2 km/h, 6km). walking Treadmill | 0 | None | 0 | 42 | 0 | 42 | View |
| Outdoor Mountain Hiking (M) | First part of the intervention: an uphill walking phase on single trails and forest roads in a sparse forest with view on the mountainous region around Innsbruck for 6 km in around 1.5 hours together with the test leader. Regarding the walking intensity, the participants were instructed to choose a "brisk without overspending" pace (average speed: 4 km/h). In the second part of the intervention, the participants were walking downhill on the same track for around 70 minutes back to the starting point to respond to the post-test (average speed: 5.2 km/h). walking | 0 | None | 0 | 42 | 0 | 42 | View |
| Sedentary Control Condition (C) | The sedentary control situation was located in a quiet room at the university with access to computers. The participants were allowed to use the computers, to read, and to talk, but had to remain in a sedentary position. To control for possible differences in affective response due to the daytime, the sedentary control condition contained the same timing of the measurements than the intervention condition. Sociodemographic data were collected for 5 to 10 minutes in this condition using a web-based questionnaire. | 0 | None | 0 | 42 | 0 | 42 | View |