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

Primary Purpose

Constipation

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
combined resistance and aerobic exercise training
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, resistance exercise, aerobic exercise, pelvic floor muscle training

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cheng Kung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training group

Control group

Arm Description

Aerobic exercise Resistance exercise (including pelvic floor muscle training with biofeedback) Stretching exercise Home exercise

.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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 3, 2020
Last Updated
April 5, 2022
Sponsor
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT04661202
Brief Title
Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation
Official Title
Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, resistance exercise, aerobic exercise, pelvic floor muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training group
Arm Type
Experimental
Arm Description
Aerobic exercise Resistance exercise (including pelvic floor muscle training with biofeedback) Stretching exercise Home exercise
Arm Title
Control group
Arm Type
No Intervention
Arm Description
.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.
Intervention Type
Other
Intervention Name(s)
combined resistance and aerobic exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of constipation symptoms
Description
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.
Time Frame
8 weeks
Title
Constipation symptom
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The pelvic floor muscle coordination measured by the Pelvic Floor Muscle Coordination Scale
Description
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.
Time Frame
8 weeks
Title
The pelvic floor muscle strength will be measured by digital rectal examination.
Description
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.
Time Frame
8 weeks
Title
The pelvic floor muscle function will be measured using anorectal manometry.
Description
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.
Time Frame
8 weeks
Title
Physical activity levels
Description
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.
Time Frame
8 weeks
Title
Constipation quality of life
Description
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.
Time Frame
8 weeks
Title
Adherence
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27144630
Citation
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.
Results Reference
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PubMed Identifier
30843436
Citation
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.
Results Reference
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PubMed Identifier
30945991
Citation
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.
Results Reference
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PubMed Identifier
10522604
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
31094054
Citation
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.
Results Reference
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PubMed Identifier
2058632
Citation
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.
Results Reference
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PubMed Identifier
12900694
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation

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