Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation

Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation: A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04661202

Enrollment

Registered

2020-12-10

Start date

2021-01-01

Completion date

2022-07-31

Last updated

2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

constipation, resistance exercise, aerobic exercise, pelvic floor muscle training

Brief summary

Constipation is a common problem in the general population. Defecation disorders caused by abnormal contraction or insufficient relaxation of the pelvic floor muscles during defecation may be one of the most possible causes of constipation. Although constipation is not life-threatening, it may have a significant impact on the quality of life. Aerobic exercise has been shown to improve symptoms of constipation in adults with constipation. However, there is no research investigating the effects of a multimodal exercise training on pelvic floor symptoms and pelvic floor muscle function in this population and only few studies have evaluated the pelvic floor muscle function using objective assessment tools among this population. The aim of the study is to investigate the effect of a multimodal exercise training program on constipation symptoms and pelvic floor muscle function in adults with constipation. The investigator will conduct a randomized controlled trial to evaluate the effectiveness of exercise training for adults with constipation. This study hypothesizes that (1) a multimodal exercise training can improve pelvic floor symptoms and function in adults with constipation, and (2) the improvement in exercise training group will be higher than that in control group.

Detailed description

This is a randomized controlled trial. Adults with constipation will be recruited and randomly assigned to either the intervention group or the control group. The intervention group will receive 16 sessions of therapist-supervised, combined resistance (including pelvic floor muscle training) and aerobic exercise training twice weekly for 8 weeks. The control group will receive usual care. All participants will be assessed at baseline and post-intervention. The primary outcome measure is the severity of the patient's self-reported constipation symptoms measured using the Patient Assessment of Constipation Symptoms Questionnaire (PACSYM). The secondary outcomes are pelvic floor muscle function assessed through the Pelvic Floor Muscle Coordination Scale (PFMCS), digital rectal examination, and anorectal manometry; quality of life measured by the Patient Assessment of Constipation Quality of Life Questionnaire (PACQOL); and physical activity levels measured using the International Physical Activity Questionnaire (IPAQ). Intention-to-treat analysis will be performed to preserve the sample size and original randomization. Mann-Whitneyand Chi-square testsest will be used for continuota and categorical data to compare the baseline characteristics between the two groups. Wilcoxon signed-rank test and the Mann-Whitney U test will be used for intragroup and intergroup comparison of outcome variables. The p-value of \< 0.05 will be considered statistically significant.

Interventions

OTHERmultimodal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Aged between 20 years and 64 years * Participants who fulfill the Rome IV criteria for constipation which include two or more of the following: a) straining \> 25% of defecations; b) lumpy or hard stools \> 25% of defecations; c) sensation of incomplete evacuation \> 25% of defecations; d) sensation of anorectal obstruction/blockage \> 25% of defecations; e) manual maneuvers to facilitate \> 25% of defecations; f) \< 3 spontaneous bowel movements per week * Participants who have sufficient language skills to participate

Exclusion criteria

* Participants who have received exercise or pelvic floor muscle training under supervision in the past 12 months * Participants with previous abdominal surgery, anorectal trauma or surgery, or previous diagnosis of neuropathy or anal sphincter dysfunction * Presence of malignancies, severe cardiovascular disease or other severe physical/psychiatric impairments that prevent participation in the study * Pregnant or within 12 months postpartum

Design outcomes

Primary

Measure	Time frame	Description
Severity of Constipation Symptoms	absolute values at 8 weeks	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.
Constipation Symptoms	absolute values at 8 weeks	A 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.
Constipation Symptom-Stool Consistency	absolute values at 8 weeks	A 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.
Constipation Symptom-Time Spent During Defecation	absolute values at 8 weeks	A Seven Day Bowel Diary includes items regarding time spent during defecation.

Secondary

Measure	Time frame	Description
Physical Activity Levels	absolute values at 8 weeks	The 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.
The Pelvic Floor Muscle Coordination Measured by the Pelvic Floor Muscle Coordination Scale	absolute values at 8 weeks	The 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.
Adherence	absolute values at 8 weeks	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.
Constipation Quality of Life	absolute values at 8 weeks	Patient 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.
The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.	absolute values at 8 weeks	Resting 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.
The Pelvic Floor Muscle Function Will be Measured Using Anorectal Manometry.	absolute values at 8 weeks	Participants 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).
The Pelvic Floor Muscle Endurance Will be Measured Using Anorectal Manometry and Stopwatch.	absolute values at 8 weeks	Participants 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.

Countries

Taiwan

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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.	14
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.	13
Total	27

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lack of Efficacy	2	0
Overall Study	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	Exercise Training Group	Total	Control Group
Age, Continuous	36.07 years STANDARD_DEVIATION 12.47	36.96 years STANDARD_DEVIATION 14.13	37.92 years STANDARD_DEVIATION 16.19
Body mass index (BMI)	22.8 kilogram/meter^2 STANDARD_DEVIATION 2.82	23.2 kilogram/meter^2 STANDARD_DEVIATION 4.21	23.6 kilogram/meter^2 STANDARD_DEVIATION 5.43
Educational level Bachelor's degree/Junior college	8 Participants	16 Participants	8 Participants
Educational level Doctoral degree	1 Participants	1 Participants	0 Participants
Educational level Junior high school	0 Participants	1 Participants	1 Participants
Educational level Master's degree	1 Participants	4 Participants	3 Participants
Educational level Senior/Vocational high school	4 Participants	5 Participants	1 Participants
Gravidity 0	5 Participants	11 Participants	6 Participants
Gravidity 1	1 Participants	1 Participants	0 Participants
Gravidity 2	4 Participants	8 Participants	4 Participants
Gravidity 3	1 Participants	1 Participants	0 Participants
Gravidity ≥4	2 Participants	3 Participants	1 Participants
Height	161.6 centimeter STANDARD_DEVIATION 7.51	160.7 centimeter STANDARD_DEVIATION 6.81	159.7 centimeter STANDARD_DEVIATION 6.12
Living status Living alone	5 Participants	7 Participants	2 Participants
Living status Living in dormitory	1 Participants	2 Participants	1 Participants
Living status Living with family	8 Participants	18 Participants	10 Participants
Marital status Divorced	1 Participants	1 Participants	0 Participants
Marital status Married	7 Participants	12 Participants	5 Participants
Marital status Single	6 Participants	14 Participants	8 Participants
Menstrual cycle status Menstruating	10 Participants	17 Participants	7 Participants
Menstrual cycle status Peri-menopause	1 Participants	4 Participants	3 Participants
Menstrual cycle status Post-menopause	2 Participants	3 Participants	1 Participants
Parity 0	5 Participants	11 Participants	6 Participants
Parity 1	2 Participants	2 Participants	0 Participants
Parity 2	6 Participants	11 Participants	5 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Sex: Female, Male Female	13 Participants	24 Participants	11 Participants
Sex: Female, Male Male	1 Participants	3 Participants	2 Participants
Smoking status Current smoker	1 Participants	2 Participants	1 Participants
Smoking status Ex-smoker	0 Participants	1 Participants	1 Participants
Smoking status Never smoked	13 Participants	24 Participants	11 Participants
Use of laxatives	3 Participants	6 Participants	3 Participants
Weight	59.5 kilogram STANDARD_DEVIATION 8.02	60.0 kilogram STANDARD_DEVIATION 12.67	60.5 kilogram STANDARD_DEVIATION 16.66
Working status Full time	7 Participants	12 Participants	5 Participants
Working status Part time	1 Participants	2 Participants	1 Participants
Working status Unemployed	6 Participants	13 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 14	0 / 13
other Total, other adverse events	0 / 14	0 / 13
serious Total, serious adverse events	0 / 14	0 / 13

Outcome results

Primary

Constipation Symptoms

A 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.