Skip to main content
OpenTrials
Completed

NCT Number: NCT04661202

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimodal exercise training

Other

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 outcomes

  1. Severity of Constipation Symptoms

    Time frame: 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.

  2. Constipation Symptoms

    Time frame: 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.

  3. Constipation Symptom-Stool Consistency

    Time frame: 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.

  4. Constipation Symptom-Time Spent During Defecation

    Time frame: absolute values at 8 weeks

    A Seven Day Bowel Diary includes items regarding time spent during defecation.

Secondary outcomes

  1. The Pelvic Floor Muscle Coordination Measured by the Pelvic Floor Muscle Coordination Scale

    Time frame: 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.

  2. The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.

    Time frame: 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".

  3. The Pelvic Floor Muscle Function Will be Measured Using Anorectal Manometry.

    Time frame: 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).

  4. The Pelvic Floor Muscle Endurance Will be Measured Using Anorectal Manometry and Stopwatch.

    Time frame: 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.

  5. Physical Activity Levels

    Time frame: 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.

  6. Constipation Quality of Life

    Time frame: 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.

  7. Adherence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2020
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.