- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04661202
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tainan, Taiwan, 704
- National Cheng Kung University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise training group
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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. |
No Intervention: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of constipation symptoms
Time Frame: 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.
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8 weeks
|
Constipation symptom
Time Frame: 8 weeks
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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.
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pelvic floor muscle coordination measured by the Pelvic Floor Muscle Coordination Scale
Time Frame: 8 weeks
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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.
Time Frame: 8 weeks
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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.
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8 weeks
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The pelvic floor muscle function will be measured using anorectal manometry.
Time Frame: 8 weeks
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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.
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8 weeks
|
Physical activity levels
Time Frame: 8 weeks
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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.
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8 weeks
|
Constipation quality of life
Time Frame: 8 weeks
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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.
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8 weeks
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Adherence
Time Frame: 8 weeks
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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.
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8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.
- Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
- Rao SS, Bharucha AE, Chiarioni G, Felt-Bersma R, Knowles C, Malcolm A, Wald A. Functional Anorectal Disorders. Gastroenterology. 2016 Mar 25:S0016-5085(16)00175-X 10.1053/j.gastro.2016.02.009. doi: 10.1053/j.gastro.2016.02.009. Online ahead of print.
- Gao R, Tao Y, Zhou C, Li J, Wang X, Chen L, Li F, Guo L. Exercise therapy in patients with constipation: a systematic review and meta-analysis of randomized controlled trials. Scand J Gastroenterol. 2019 Feb;54(2):169-177. doi: 10.1080/00365521.2019.1568544. Epub 2019 Mar 7.
- Virtuoso JF, Menezes EC, Mazo GZ. Effect of Weight Training with Pelvic Floor Muscle Training in Elderly Women with Urinary Incontinence. Res Q Exerc Sport. 2019 Jun;90(2):141-150. doi: 10.1080/02701367.2019.1571674. Epub 2019 Apr 4.
- Sadowy AM, Brouwer HL, Finseth DL, Hagener KM, Lawrence AE, Hollman JH. Development of a Pelvic Floor Muscle Coordination Scale. Journal of Women's Health Physical Therapy. 2010;34(3):81-8.
- Gosling J, Plumb A, Taylor SA, Cohen R, Emmanuel AV. High-resolution anal manometry: Repeatability, validation, and comparison with conventional manometry. Neurogastroenterol Motil. 2019 Jun;31(6):e13591. doi: 10.1111/nmo.13591.
- Kaushal JN, Goldner F. Validation of the digital rectal examination as an estimate of anal sphincter squeeze pressure. Am J Gastroenterol. 1991 Jul;86(7):886-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-BR-109-090
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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