Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Constipation Symptom-Time Spent During Defecation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Exercise training group
- Aerobic exercise
- Resistance exercise (including pelvic floor muscle training with biofeedback)
- Stretching exercise
- Home exercise
干预措施: multimodal exercise training (Other)
Control group
・ 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.
结局指标
主要结局
Constipation Symptom-Time Spent During Defecation
时间窗: absolute values at 8 weeks
A Seven Day Bowel Diary includes items regarding time spent during defecation.
Severity of Constipation Symptoms
时间窗: 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.
Constipation Symptoms
时间窗: 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.
Constipation Symptom-Stool Consistency
时间窗: 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.
次要结局
- The Pelvic Floor Muscle Coordination Measured by the Pelvic Floor Muscle Coordination Scale(absolute values at 8 weeks)
- Constipation Quality of Life(absolute values at 8 weeks)
- The Pelvic Floor Muscle Strength Will be Measured by Digital Rectal Examination.(absolute values at 8 weeks)
- The Pelvic Floor Muscle Function Will be Measured Using Anorectal Manometry.(absolute values at 8 weeks)
- The Pelvic Floor Muscle Endurance Will be Measured Using Anorectal Manometry and Stopwatch.(absolute values at 8 weeks)
- Physical Activity Levels(absolute values at 8 weeks)
- Adherence(absolute values at 8 weeks)
研究者
Kuan-Yin Lin
Assistant professor
National Cheng Kung University