Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation: A Randomized Controlled Trial
Phase: NA
Conditions: Constipation
Sponsor: National Cheng Kung University

Official title: Effects of Exercise Training on Pelvic Floor Symptoms and Function in 
Adults with Constipation: A Randomized Controlled Trial 
NCT number: NCT04661202 
Document date: December 25, 2020 
 
 

Study protocol 
Constipation is a common problem in adult population1. Constipation may also lead to 
pelvic floor muscle dysfunction due to prolonged stress on the pelvic floor. The 
recommended initial treatment for constipation includes lifestyle modifications (e.g., 
increasing physical activity, balanced diet) and laxatives2. Pelvic floor muscle training 
(PFMT) with biofeedback has been recognized as an effective therapy for relieving 
constipation in patients who have failed initial treatment3. Since constipation is a 
multifactorial disorder, a multimodal intervention program may be more effective 
than single treatment in solving constipation problem4. 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. This study aims to evaluate the effectiveness of a multimodal exercise 
training program on constipation symptoms and pelvic floor muscle function in adults 
with constipation. 
This is a randomized controlled trial. Adults with functional constipation will be 
recruited and randomly assigned to two groups, the intervention group, or the control 
group. The intervention group will receive 16 sessions of physical therapist 
supervised, combined resistance (including PFMT) and aerobic exercise training 
twice weekly for 8 weeks, and home exercises (PFMT and walking). The control 
group will receive only one session of usual care after baseline assessment. 
Assessments will be performed at baseline and after eight-week program. The primary 
outcome measure is the severity of patient’s self-reported constipation symptoms. The 
secondary outcome measures include the pelvic floor muscle function, physical 
activity levels, constipation-related quality of life, and 7-day bowel chart will also be 
collected. Moreover, adherence will be calculated separately for PFMT and walking 

as the days of home exercises completed over 56 days in intervention group. 
Statistical analysis plan 
Intention-to-treat analysis will be performed to preserve the sample size and original 
randomization. For participants who have a missing outcome in baseline assessment, 
the outcome value will be estimated through calculating mean and mode from the 
existing data. For those who have a missing outcome in post-intervention assessment, 
the observation from baseline assessment will be carried forward. Shapiro-Wilk test 
will be used to evaluate the normality of data. Descriptive data will be presented as 
number, percentage, mean and standard deviation (SD). Mann-Whitney U test and 
Chi-square test will be used for continuous data and categorical data to compare the 
baseline characteristics between 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 as statistically significant. All data 
analyses will be performed using SPSS software version 25.0. 
References 
1. 
Andrews CN, Storr M. The pathophysiology of chronic constipation. Can J 
Gastroenterol. 2011;25(Suppl B):16B-21B.  
2. 
Wlodarczyk J, Wasniewska A, Fichna J, Dziki A, Dziki L, Wlodarczyk M. 
Current overview on clinical management of chronic constipation. J Clin Med. 
2021;10(8):1738. 
3. 
Rao SS, Benninga MA, Bharucha AE, Chiarioni G, Di Lorenzo C, Whitehead 
WE. ANMS‐ESNM position paper and consensus guidelines on biofeedback therapy 
for anorectal disorders. Neurogastroenterol Motil. 2015;27(5):594-609.  
4. 
George SE, Borello-France DF. Perspective on physical therapist management of 
functional constipation. Phys Ther. 2017;97(4):478-93.