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

Study Overview
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Brief Summary
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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 combined resistance and aerobic 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 combined resistance and aerobic 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 combined resistance and aerobic exercise training can improve pelvic floor symptoms and function in adults with constipation, and (2) the improvement in combined resistance and aerobic exercise training group will be higher than that in control group.

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

Conditions
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Constipation

Intervention / Treatment
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* Other: combined resistance and aerobic exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training group<br>Aerobic exercise Resistance exercise (including pelvic floor muscle training with biofeedback) Stretching exercise Home exercise | Other: combined resistance and aerobic exercise training<br>* 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.<br>|
| No Intervention: Control group<br>．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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of constipation symptoms | 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. | 8 weeks | 
| Constipation symptom | A Seven Day Bowel Diary includes items regarding the frequency of bowel movement, stool consistency, defecation time, excessive straining defecation, using of digital maneuver, and changes in food and liquid consumption. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pelvic floor muscle coordination measured by the Pelvic Floor Muscle Coordination Scale | 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. | 8 weeks | 
| The pelvic floor muscle strength will be measured by digital rectal examination. | Resting tone, maximal voluntary contraction of external anal sphincter and puborectalis, voluntary relaxation and straining will be measured and scored using the International Continence Society scale. | 8 weeks | 
| The pelvic floor muscle function will be measured using anorectal manometry. | 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 centimeter of water. | 8 weeks | 
| Physical activity levels | 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. | 8 weeks | 
| Constipation quality of life | 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 the symptoms on a five-point Likert scale, ranging from 0 to 4. A higher score indicates greater impact on quality of life. | 8 weeks | 
| Adherence | Participants will be asked to record the number of completed home exercise in the exercise diary. It will be calculated as the adherence rate of home program. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, resistance exercise, aerobic exercise, pelvic floor muscle training