Clinical trial NCT04661202: 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
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: constipation
resistance exercise
aerobic exercise
pelvic floor muscle training
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Severity of Constipation Symptoms
timeFrame: absolute values at 8 weeks
measure: Constipation Symptoms
timeFrame: absolute values at 8 weeks
measure: Constipation Symptom-Stool Consistency
timeFrame: absolute values at 8 weeks
measure: Constipation Symptom-Time Spent During Defecation
timeFrame: absolute values at 8 weeks
Secondary outcomes:
measure: The Pelvic Floor Muscle Coordination Measured by the Pelvic Floor Muscle Coordination Scale
timeFrame: absolute values at 8 weeks
measure: The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.
timeFrame: absolute values at 8 weeks
measure: The Pelvic Floor Muscle Function Will be Measured Using Anorectal Manometry.
timeFrame: absolute values at 8 weeks
measure: The Pelvic Floor Muscle Endurance Will be Measured Using Anorectal Manometry and Stopwatch.
timeFrame: absolute values at 8 weeks
measure: Physical Activity Levels
timeFrame: absolute values at 8 weeks
measure: Constipation Quality of Life
timeFrame: absolute values at 8 weeks
measure: Adherence
timeFrame: absolute values at 8 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Kuan-Yin Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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