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

NCT ID: NCT04661202

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-07-31

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise training group

• Aerobic exercise
• Resistance exercise (including pelvic floor muscle training with biofeedback)
• Stretching exercise
• Home exercise

Group Type: EXPERIMENTAL

multimodal exercise training

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

multimodal exercise training

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng Kung University

OTHER

Sponsor Role: lead

Responsible Party

Kuan-Yin Lin

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuan-Yin Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

National Cheng Kung University

Tainan City, , Taiwan

Countries

Taiwan

References

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

B-BR-109-090

Identifier Type: -

Identifier Source: org_study_id