Trial Outcomes & Findings for Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence (NCT NCT04351750)
NCT ID: NCT04351750
Last Updated: 2023-03-31
Results Overview
Pelvic floor muscle function (muscle strength) was measured through digital palpation. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction (MVC). The result was recorded using the modified Oxford grading scale, a six-point system with higher score indicated stronger muscle strength (0 = no contraction, 1 = flicker, 2 = weak, 3 = moderate with lift, 4 = good with lift, 5 = strong with lift).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
absolute values at 8 weeks
Results posted on
2023-03-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
18
|
|
Overall Study
COMPLETED
|
12
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High-intensity Group
n=12 Participants
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.
|
Low-intensity Group
n=13 Participants
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.
|
Control Group
n=13 Participants
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.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 6.1 • n=12 Participants
|
65.6 years
STANDARD_DEVIATION 8.63 • n=13 Participants
|
62.3 years
STANDARD_DEVIATION 8.8 • n=13 Participants
|
64.9 years
STANDARD_DEVIATION 8.0 • n=38 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
38 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
12 participants
n=12 Participants
|
13 participants
n=13 Participants
|
13 participants
n=13 Participants
|
38 participants
n=38 Participants
|
|
Body Mass Index
|
24.06 kg/m^2
STANDARD_DEVIATION 4.52 • n=12 Participants
|
25.44 kg/m^2
STANDARD_DEVIATION 5.64 • n=13 Participants
|
24.95 kg/m^2
STANDARD_DEVIATION 4.92 • n=13 Participants
|
24.75 kg/m^2
STANDARD_DEVIATION 4.92 • n=38 Participants
|
PRIMARY outcome
Timeframe: absolute values at 8 weeksPopulation: There were three missing data of pelvic floor muscle function (high-intensity group n=1, low-intensity group n=1, control group n=1) as the participants declined the assessment due to embarrassment with the test.
Pelvic floor muscle function (muscle strength) was measured through digital palpation. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction (MVC). The result was recorded using the modified Oxford grading scale, a six-point system with higher score indicated stronger muscle strength (0 = no contraction, 1 = flicker, 2 = weak, 3 = moderate with lift, 4 = good with lift, 5 = strong with lift).
Outcome measures
| Measure |
High-intensity Group
n=11 Participants
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.
|
Low-intensity Group
n=12 Participants
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.
|
Control Group
n=12 Participants
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.
|
|---|---|---|---|
|
Pelvic Floor Muscle Function Measured by Digital Palpation
|
4.00 score on a scale
Standard Deviation 0.89
|
3.25 score on a scale
Standard Deviation 0.87
|
3.75 score on a scale
Standard Deviation 1.14
|
PRIMARY outcome
Timeframe: absolute values at 8 weeksPopulation: There were three missing data of pelvic floor muscle function (high-intensity group n=1, low-intensity group n=1, control group n=1) as the participants declined the assessment due to embarrassment with the test.
The manometry supplied by Laborie® Biofeedback and Stimulation System was used to assess vaginal squeeze pressure, and the unit of pressure was registered in millimeter of mercury (mmHg). The participants were asked to perform 3 times of MVC, holding for 5 seconds with 5 seconds interval resting time, and the maximum value among the three MVC was recorded. The muscle strength was calculated as the value of MVC minus resting tone.
Outcome measures
| Measure |
High-intensity Group
n=11 Participants
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.
|
Low-intensity Group
n=12 Participants
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.
|
Control Group
n=12 Participants
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.
|
|---|---|---|---|
|
Pelvic Floor Muscle Function Measured by Manometry
|
16.64 mmHg
Standard Deviation 21.55
|
8.58 mmHg
Standard Deviation 7.64
|
13.23 mmHg
Standard Deviation 13.92
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksThe International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form will be used to assess the severity of UI symptoms. The total score ranges from 0 to 21; a higher score indicates greater severity.
Outcome measures
| Measure |
High-intensity Group
n=12 Participants
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.
|
Low-intensity Group
n=13 Participants
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.
|
Control Group
n=13 Participants
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.
|
|---|---|---|---|
|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
|
6.75 score on a scale
Standard Deviation 3.62
|
4.92 score on a scale
Standard Deviation 3.67
|
7.15 score on a scale
Standard Deviation 4.28
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksThe International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life will be used to evaluate quality of life in UI patients. The total score ranges from 19 to 76. A higher score indicates greater impact on quality of life.
Outcome measures
| Measure |
High-intensity Group
n=12 Participants
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.
|
Low-intensity Group
n=13 Participants
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.
|
Control Group
n=13 Participants
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.
|
|---|---|---|---|
|
International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life
|
32.17 score on a scale
Standard Deviation 9.46
|
27.85 score on a scale
Standard Deviation 8.76
|
32.69 score on a scale
Standard Deviation 7.01
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksThe International Prostate Symptom Score will be used to evaluate the severity of lower urinary tract symptoms. The total score ranges from 0 to 35. A higher score indicates greater severity.
Outcome measures
| Measure |
High-intensity Group
n=12 Participants
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.
|
Low-intensity Group
n=13 Participants
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.
|
Control Group
n=13 Participants
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.
|
|---|---|---|---|
|
International Prostate Symptom Score
|
7.25 score on a scale
Standard Deviation 3.62
|
6.31 score on a scale
Standard Deviation 4.89
|
8.23 score on a scale
Standard Deviation 5.88
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksPopulation: There were four missing data in total (high-intensity group n=1, low-intensity group n=1, control group n=2) as the participants did not return the diary or the recording information was incomplete.
The participants had to record the frequency of daytime urination for three days but not necessarily consecutive. Daytime frequency was defined as the number of voids since first void after waking to last void before sleep.
Outcome measures
| Measure |
High-intensity Group
n=11 Participants
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.
|
Low-intensity Group
n=12 Participants
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.
|
Control Group
n=11 Participants
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.
|
|---|---|---|---|
|
3-day Bladder Diary
|
7.76 voids per day
Standard Deviation 1.21
|
8.00 voids per day
Standard Deviation 2.64
|
8.18 voids per day
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksPopulation: There were two missing data of physical activity levels (low-intensity group n=1, control group n=1) as the participants reported "not sure" in the time spending in physical activity.
The International Physical Activity Questionnaire will be used to measure participants' physical activity levels. The questionnaire assessed the time people spending in physical activity in the last seven days, and the intensity of physical activity level was divided into vigorous, moderate, and walking. The total physical activity levels were calculated by a formula: total MET-minutes/week (Metabolic equivalent of task- minutes per week) = Vigorous intensity (8.0 METs\*min\*day) + Moderate intensity (4.0 METs\*min\*days) + Walking (3.3 METs\*min\*days). A higher score indicates a greater physical activity levels.
Outcome measures
| Measure |
High-intensity Group
n=12 Participants
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.
|
Low-intensity Group
n=12 Participants
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.
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Control Group
n=12 Participants
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.
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International Physical Activity Questionnaire
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2624.35 MET-min/week
Standard Deviation 1390.43
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2133.54 MET-min/week
Standard Deviation 1024.29
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1814.25 MET-min/week
Standard Deviation 1511.58
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Adverse Events
High-intensity Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low-intensity Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place