N/A
Completed N=27
Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation
Source: ClinicalTrials.gov NCT04661202 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Severity of Constipation Symptoms — 0.96; 0.97; 0.63; 0.67 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Constipation Symptoms |
0.96; 0.97; 0.63; 0.67; 0.67; 0.64 | — |
| PRIMARY Constipation Symptoms |
5.14; 5.54; 0; 0; 0.43; 0.62 | — |
| PRIMARY Constipation Symptom-Stool Consistency |
3.74; 3.46 | — |
| PRIMARY Constipation Symptom-Time Spent During Defecation |
12.06; 9.46 | — |
| SECONDARY The Pelvic Floor Muscle Coordination Measured by the Pelvic Floor Muscle Coordination Scale |
1.79; 2.31 | — |
| SECONDARY The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination. |
0.71; 0.62; 1.14; 1.15; 1.50; 1.31 | — |
| SECONDARY The Pelvic Floor Muscle Function Will be Measured Using Anorectal Manometry. |
2.14; 1.82; 50.73; 46.52; 23.01; 16.42 | — |
| SECONDARY The Pelvic Floor Muscle Endurance Will be Measured Using Anorectal Manometry and Stopwatch. |
6.78; 6.11 | — |
| SECONDARY Physical Activity Levels |
1069.25; 1253.85; 262.86; 418.46; 331.43; 378.46 | — |
| SECONDARY Constipation Quality of Life |
1.30; 1.60; 1.16; 1.38; 1.28; 1.69 | — |
| SECONDARY Adherence |
33; 28 | — |
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
Data sourced from ClinicalTrials.gov (NCT04661202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.