Trial Outcomes & Findings for Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation (NCT NCT04661202)
NCT ID: NCT04661202
Last Updated: 2024-08-02
Results Overview
The Patient Assessment of Constipation Symptoms questionnaire will be used to assess the severity of constipation symptoms. This questionnaire includes a total of 12 items in 3 subscales: abdominal (4 items), rectal (3 items), and stool (5 items). Participant will be asked to rank the symptoms on a five-point Likert scale, ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 48 which will be divided by the actual number of items answered. The higher score indicates the greater severity of constipation symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
absolute values at 8 weeks
Results posted on
2024-08-02
Participant Flow
Participants were recruited from the outpatient department of Colorectal Surgery of National Cheng Kung University Hospital, Tainan, Taiwan, the clinic, community, and social media from January 2021 to June 2022.
Participant milestones
| Measure |
Exercise Training Group
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
．Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Exercise Training Group
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
．Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.07 years
STANDARD_DEVIATION 12.47 • n=14 Participants
|
37.92 years
STANDARD_DEVIATION 16.19 • n=13 Participants
|
36.96 years
STANDARD_DEVIATION 14.13 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=14 Participants
|
11 Participants
n=13 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=14 Participants
|
2 Participants
n=13 Participants
|
3 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
161.6 centimeter
STANDARD_DEVIATION 7.51 • n=14 Participants
|
159.7 centimeter
STANDARD_DEVIATION 6.12 • n=13 Participants
|
160.7 centimeter
STANDARD_DEVIATION 6.81 • n=27 Participants
|
|
Weight
|
59.5 kilogram
STANDARD_DEVIATION 8.02 • n=14 Participants
|
60.5 kilogram
STANDARD_DEVIATION 16.66 • n=13 Participants
|
60.0 kilogram
STANDARD_DEVIATION 12.67 • n=27 Participants
|
|
Body mass index (BMI)
|
22.8 kilogram/meter^2
STANDARD_DEVIATION 2.82 • n=14 Participants
|
23.6 kilogram/meter^2
STANDARD_DEVIATION 5.43 • n=13 Participants
|
23.2 kilogram/meter^2
STANDARD_DEVIATION 4.21 • n=27 Participants
|
|
Smoking status
Current smoker
|
1 Participants
n=14 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=27 Participants
|
|
Smoking status
Ex-smoker
|
0 Participants
n=14 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=27 Participants
|
|
Smoking status
Never smoked
|
13 Participants
n=14 Participants
|
11 Participants
n=13 Participants
|
24 Participants
n=27 Participants
|
|
Educational level
Doctoral degree
|
1 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=27 Participants
|
|
Educational level
Master's degree
|
1 Participants
n=14 Participants
|
3 Participants
n=13 Participants
|
4 Participants
n=27 Participants
|
|
Educational level
Bachelor's degree/Junior college
|
8 Participants
n=14 Participants
|
8 Participants
n=13 Participants
|
16 Participants
n=27 Participants
|
|
Educational level
Senior/Vocational high school
|
4 Participants
n=14 Participants
|
1 Participants
n=13 Participants
|
5 Participants
n=27 Participants
|
|
Educational level
Junior high school
|
0 Participants
n=14 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=27 Participants
|
|
Working status
Full time
|
7 Participants
n=14 Participants
|
5 Participants
n=13 Participants
|
12 Participants
n=27 Participants
|
|
Working status
Part time
|
1 Participants
n=14 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=27 Participants
|
|
Working status
Unemployed
|
6 Participants
n=14 Participants
|
7 Participants
n=13 Participants
|
13 Participants
n=27 Participants
|
|
Marital status
Single
|
6 Participants
n=14 Participants
|
8 Participants
n=13 Participants
|
14 Participants
n=27 Participants
|
|
Marital status
Married
|
7 Participants
n=14 Participants
|
5 Participants
n=13 Participants
|
12 Participants
n=27 Participants
|
|
Marital status
Divorced
|
1 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=27 Participants
|
|
Living status
Living with family
|
8 Participants
n=14 Participants
|
10 Participants
n=13 Participants
|
18 Participants
n=27 Participants
|
|
Living status
Living alone
|
5 Participants
n=14 Participants
|
2 Participants
n=13 Participants
|
7 Participants
n=27 Participants
|
|
Living status
Living in dormitory
|
1 Participants
n=14 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=27 Participants
|
|
Use of laxatives
|
3 Participants
n=14 Participants
|
3 Participants
n=13 Participants
|
6 Participants
n=27 Participants
|
|
Menstrual cycle status
Menstruating
|
10 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
7 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
17 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Menstrual cycle status
Peri-menopause
|
1 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
3 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
4 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Menstrual cycle status
Post-menopause
|
2 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
1 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
3 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Gravidity
0
|
5 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
6 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
11 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Gravidity
1
|
1 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
0 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
1 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Gravidity
2
|
4 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
4 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
8 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Gravidity
3
|
1 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
0 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
1 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Gravidity
≥4
|
2 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
1 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
3 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Parity
0
|
5 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
6 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
11 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Parity
1
|
2 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
0 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
2 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
|
Parity
2
|
6 Participants
n=13 Participants • Only the female participant had to answer this item in the questionnaire.
|
5 Participants
n=11 Participants • Only the female participant had to answer this item in the questionnaire.
|
11 Participants
n=24 Participants • Only the female participant had to answer this item in the questionnaire.
|
PRIMARY outcome
Timeframe: absolute values at 8 weeksThe Patient Assessment of Constipation Symptoms questionnaire will be used to assess the severity of constipation symptoms. This questionnaire includes a total of 12 items in 3 subscales: abdominal (4 items), rectal (3 items), and stool (5 items). Participant will be asked to rank the symptoms on a five-point Likert scale, ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 48 which will be divided by the actual number of items answered. The higher score indicates the greater severity of constipation symptoms.
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
Severity of Constipation Symptoms
Abdominal
|
0.63 score on a scale
Standard Deviation 0.47
|
0.67 score on a scale
Standard Deviation 0.98
|
|
Severity of Constipation Symptoms
Rectal
|
0.67 score on a scale
Standard Deviation 0.81
|
0.64 score on a scale
Standard Deviation 1.17
|
|
Severity of Constipation Symptoms
Stool
|
1.40 score on a scale
Standard Deviation 0.94
|
1.40 score on a scale
Standard Deviation 0.74
|
|
Severity of Constipation Symptoms
Total
|
0.96 score on a scale
Standard Deviation 0.59
|
0.97 score on a scale
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: absolute values at 8 weeksA Seven Day Bowel Diary includes items regarding the stool frequency, presence of incontinence, excessive straining, manual maneuver, or pain during defecation, and the use of laxatives.
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
Constipation Symptoms
Stool frequency
|
5.14 number/week
Standard Deviation 1.70
|
5.54 number/week
Standard Deviation 1.76
|
|
Constipation Symptoms
Incontinence
|
0 number/week
Standard Deviation 0
|
0 number/week
Standard Deviation 0
|
|
Constipation Symptoms
Excessive straining
|
0.43 number/week
Standard Deviation 0.85
|
0.62 number/week
Standard Deviation 0.96
|
|
Constipation Symptoms
Manual maneuver
|
0.07 number/week
Standard Deviation 0.27
|
0.46 number/week
Standard Deviation 1.66
|
|
Constipation Symptoms
Pain during defecation
|
0.64 number/week
Standard Deviation 0.93
|
0.46 number/week
Standard Deviation 0.97
|
|
Constipation Symptoms
Use of laxatives
|
1.14 number/week
Standard Deviation 2.51
|
1.15 number/week
Standard Deviation 2.61
|
PRIMARY outcome
Timeframe: absolute values at 8 weeksA Seven Day Bowel Diary includes the item regarding stool consistency. The Bristol Stool Form Scale describing the shapes and types of stools is used to evaluate stool consistency. This scale assigns a number (1-7) with 1 indicating hardest to 7 indicating loosest, to classify human feces based on its shape and and how formed or loose it is.
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
Constipation Symptom-Stool Consistency
|
3.74 score on a scale
Standard Deviation 1.44
|
3.46 score on a scale
Standard Deviation 1.33
|
PRIMARY outcome
Timeframe: absolute values at 8 weeksA Seven Day Bowel Diary includes items regarding time spent during defecation.
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
Constipation Symptom-Time Spent During Defecation
|
12.06 minute/bowel movement
Standard Deviation 15.15
|
9.46 minute/bowel movement
Standard Deviation 9.60
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksThe Pelvic Floor Muscle Coordination Scale including 5 items, respiration, pelvic floor muscle contraction, extrapelvic muscle activation, pelvic floor muscle expansion, and cough will be used to evaluate pelvic floor muscle coordination. All will be evaluated by observation. The total score ranges from 0 to 10 and a higher score indicates the poorer pelvic floor muscle coordination.
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
The Pelvic Floor Muscle Coordination Measured by the Pelvic Floor Muscle Coordination Scale
|
1.79 score on a scale
Standard Deviation 1.25
|
2.31 score on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksResting tone, maximal voluntary contraction (MVC) of external anal sphincter and puborectalis, voluntary relaxation, and three components of defecation attempts (push effort, anal relaxation, and perineal descent) will be measured. Resting pressure was scored as "0=decreased", "1=normal", or "2=increased". Maximal voluntary contraction of external anal sphincter and puborectalis were scored separately for each muscle based on the International Continence Society scale criteria as "0=absent", "1=weak", "2=moderate", "3=strong". Voluntary relaxation was assessed after MVCs and scored as "0=absent", "1=partial", or "2=complete". Push effort was scored as "0=weak", "1=normal", or "2=excessive", anal relaxation was scored as "0=impaired", "1=normal", or "2=paradoxical contraction", and perineal descent was scored as "0=absent", "1=normal", or "2=excessive".
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.
External anal sphincter resting tone
|
0.71 score on a scale
Standard Deviation 0.47
|
0.62 score on a scale
Standard Deviation 0.51
|
|
The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.
Puborectalis resting tone
|
1.14 score on a scale
Standard Deviation 0.36
|
1.15 score on a scale
Standard Deviation 0.38
|
|
The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.
External anal sphincter maximal voluntary contraction
|
1.50 score on a scale
Standard Deviation 0.65
|
1.31 score on a scale
Standard Deviation 0.48
|
|
The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.
Puborectalis maximal voluntary contraction
|
1.64 score on a scale
Standard Deviation 0.50
|
1.77 score on a scale
Standard Deviation 0.73
|
|
The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.
Voluntary relaxation
|
1.71 score on a scale
Standard Deviation 0.61
|
1.85 score on a scale
Standard Deviation 0.38
|
|
The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.
Push effort
|
0.86 score on a scale
Standard Deviation 0.36
|
0.54 score on a scale
Standard Deviation 0.52
|
|
The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.
Anal relaxation
|
1.21 score on a scale
Standard Deviation 0.43
|
1.23 score on a scale
Standard Deviation 0.44
|
|
The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.
Perineal descent
|
1.07 score on a scale
Standard Deviation 0.27
|
0.85 score on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksParticipants will be asked to relax for 10 seconds, squeeze 3 times by holding 5 seconds with 5 seconds of rest in between, and squeeze by holding the contraction for 30 seconds. Anorectal pressure will be recorded in unit of millimeter of mercury (mmHg).
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
The Pelvic Floor Muscle Function Will be Measured Using Anorectal Manometry.
Resting pressure
|
2.14 millimeter of mercury
Standard Deviation 2.01
|
1.82 millimeter of mercury
Standard Deviation 1.26
|
|
The Pelvic Floor Muscle Function Will be Measured Using Anorectal Manometry.
Maximal voluntary contraction
|
50.73 millimeter of mercury
Standard Deviation 40.42
|
46.52 millimeter of mercury
Standard Deviation 31.92
|
|
The Pelvic Floor Muscle Function Will be Measured Using Anorectal Manometry.
Average of maximal voluntary contraction
|
23.01 millimeter of mercury
Standard Deviation 25.34
|
16.42 millimeter of mercury
Standard Deviation 17.48
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksParticipants will be asked to voluntarily squeeze their pelvic floor muscles by holding the contraction for 30 seconds. Anorectal squeeze pressure is measured using an anorectal manometry. The pelvic floor muscle endurance is recorded as the time (seconds) holding at \>50% of maximal voluntary contraction (squeeze pressure) in 30 seconds.
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
The Pelvic Floor Muscle Endurance Will be Measured Using Anorectal Manometry and Stopwatch.
|
6.78 seconds
Standard Deviation 7.53
|
6.11 seconds
Standard Deviation 8.04
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksThe International Physical Activity Questionnaire will be used to measure participants' physical activity levels. This questionnaire includes seven questions on different physical activity levels of duration and frequency and then calculated in metabolic equivalent-minutes/week. A higher score indicates a greater physical activity levels.
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
Physical Activity Levels
Walking
|
474.96 metabolic equivalent-minutes/week
Standard Deviation 539.54
|
456.92 metabolic equivalent-minutes/week
Standard Deviation 601.91
|
|
Physical Activity Levels
Total
|
1069.25 metabolic equivalent-minutes/week
Standard Deviation 747.76
|
1253.85 metabolic equivalent-minutes/week
Standard Deviation 1889.07
|
|
Physical Activity Levels
Vigorous
|
262.86 metabolic equivalent-minutes/week
Standard Deviation 354.22
|
418.46 metabolic equivalent-minutes/week
Standard Deviation 821.81
|
|
Physical Activity Levels
Moderate
|
331.43 metabolic equivalent-minutes/week
Standard Deviation 275.09
|
378.46 metabolic equivalent-minutes/week
Standard Deviation 608.51
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksPatient Assessment of Constipation Quality of Life Questionnaire will be used to evaluate the quality of life in constipation patients. This questionnaire includes a total of 28 items in 4 subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Participants will be asked to rank how constipation affects their quality of life on a five-point Likert scale, ranging from 0 to 4. A higher score indicates greater impact on quality of life.
Outcome measures
| Measure |
Exercise Training Group
n=14 Participants
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
n=13 Participants
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
Constipation Quality of Life
Satisfaction
|
2.36 score on a scale
Standard Deviation 0.85
|
2.71 score on a scale
Standard Deviation 0.51
|
|
Constipation Quality of Life
Total
|
1.30 score on a scale
Standard Deviation 0.75
|
1.60 score on a scale
Standard Deviation 0.85
|
|
Constipation Quality of Life
Physical discomfort
|
1.16 score on a scale
Standard Deviation 0.68
|
1.38 score on a scale
Standard Deviation 0.88
|
|
Constipation Quality of Life
Worries and concerns
|
1.28 score on a scale
Standard Deviation 0.97
|
1.69 score on a scale
Standard Deviation 1.12
|
|
Constipation Quality of Life
Psychosocial discomfort
|
0.72 score on a scale
Standard Deviation 0.70
|
0.89 score on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: absolute values at 8 weeksPopulation: There were three missing data of adherence (n=3) in intervention group as the participants dropped out during the eight-week program.
Participants in intervention group will be asked to record the number of completed home exercises (pelvic floor muscle training and walking) in the exercise diary. Adherence will be calculated separately for pelvic floor muscle training and walking as the days of home exercises completed over 56 days.
Outcome measures
| Measure |
Exercise Training Group
n=56 days
* Aerobic exercise
* Resistance exercise (including pelvic floor muscle training with biofeedback)
* Stretching exercise
* Home exercise
Multimodal exercise training:
A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1\~3 sets of 8\~12 submaximal contraction of PFM by holding 6\~10 seconds with 12\~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1\~3 seconds 3\~6 seconds of rest between each contraction.
|
Control Group
●Usual care
After baseline assessment, the participants will receive health and lifestyle advices related to bowel symptoms, which include maintaining moderate physical activity, healthy diet, and ideal defecation posture, and establishing a personal bowel schedule and other behavioral changes that promote regular bowel movements.
Upon request, the participants will be provided with the same intervention program as the exercise training group after 8 weeks participation.
|
|---|---|---|
|
Adherence
Pelvic floor muscle training
|
33 days
|
—
|
|
Adherence
Walking
|
28 days
|
—
|
Adverse Events
Exercise Training 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