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 @ 4:51 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
NCT ID:
NCT04351750
Description:
None
Frequency Threshold:
0
Time Frame:
through 8 week intervention
Study:
NCT04351750
Study Brief:
Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| High-intensity Group | The participants will receive high-intensity general exercise and pelvic floor muscle training in high-intensity group. The intensity of aerobic exercise is 60 \~ 89% of heart rate reserve (HRR), which is equivalent to the vigorous intensity exercise proposed in the American College of Sports Medicine (ACSM). The intensity of resistance exercise is 60\~80% of 1 repetition maximum (RM), which is equivalent to the moderate-to-vigorous intensity exercise proposed in ACSM. After finishing the general exercise, participants will receive pelvic floor muscle training. general exercise: The participants will receive training sessions twice a week for 8 weeks. General exercise includes aerobic exercise (stationary bike) and resistance training (thera-band, sandbags, dumbbell and swiss ball), and the intensity and progression of both aerobic and resistance exercises will be provided as recommended by the ACSM, and the exercise will individualized based on participant's HRR, 1 RM weight and Borg Scale of Perceived Exertion Scale. An oximeter will be utilized to monitor the heart rate and SPO2 of the participants to ensure safety during the training session. pelvic floor muscle training: Participants will do pelvic floor muscle training in different positions. Each session includes three sets of eight to twelve maximum voluntary contractions of pelvic floor muscle, with holding the contraction for 6 to 8 seconds, and if possible, to do three fast contractions at the end of each set. | 0 | None | 0 | 12 | 0 | 12 | View |
| Low-intensity Group | The participants will receive low-intensity general exercise and pelvic floor muscle training in low-intensity group. The intensity of aerobic exercise is 40\~59% of HRR, which is equivalent to the moderate intensity exercise proposed in ACSM. The intensity of resistance exercise is 40\~50% of 1RM, which is equivalent to the very light-to-light intensity exercise proposed in ACSM. After finishing the general exercise, participants will receive pelvic floor muscle training. general exercise: The participants will receive training sessions twice a week for 8 weeks. General exercise includes aerobic exercise (stationary bike) and resistance training (thera-band, sandbags, dumbbell and swiss ball), and the intensity and progression of both aerobic and resistance exercises will be provided as recommended by the ACSM, and the exercise will individualized based on participant's HRR, 1 RM weight and Borg Scale of Perceived Exertion Scale. An oximeter will be utilized to monitor the heart rate and SPO2 of the participants to ensure safety during the training session. pelvic floor muscle training: Participants will do pelvic floor muscle training in different positions. Each session includes three sets of eight to twelve maximum voluntary contractions of pelvic floor muscle, with holding the contraction for 6 to 8 seconds, and if possible, to do three fast contractions at the end of each set. | 0 | None | 0 | 13 | 0 | 13 | View |
| Control Group | The participants will only receive pelvic floor muscle training in control group. pelvic floor muscle training: Participants will do pelvic floor muscle training in different positions. Each session includes three sets of eight to twelve maximum voluntary contractions of pelvic floor muscle, with holding the contraction for 6 to 8 seconds, and if possible, to do three fast contractions at the end of each set. | 0 | None | 0 | 13 | 0 | 13 | View |
Serious Events(If Any):
Other Events(If Any):