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

NCT04661202 | Completed Results

• 1 other identifier: B-BR-109-090
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

constipation; resistance exercise; aerobic exercise; pelvic floor muscle training

Outcome Measures

Primary Outcomes (4)

• Severity of Constipation Symptoms

  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.

  absolute values at 8 weeks

• Constipation Symptoms

  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.

  absolute values at 8 weeks

• Constipation Symptom-Stool Consistency

  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.

  absolute values at 8 weeks

• Constipation Symptom-Time Spent During Defecation

  A Seven Day Bowel Diary includes items regarding time spent during defecation.

  absolute values at 8 weeks

Secondary Outcomes (7)

• The Pelvic Floor Muscle Coordination Measured by the Pelvic Floor Muscle Coordination Scale

  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

Study Arms (2)

Exercise training group

EXPERIMENTAL

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

Other: multimodal exercise training

Control group

NO INTERVENTION

・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.

Interventions

multimodal exercise training 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.

Exercise training group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University

Tainan, 704, Taiwan

Location

Related Publications (9)

• Rao SS, Bharucha AE, Chiarioni G, Felt-Bersma R, Knowles C, Malcolm A, Wald A. Functional Anorectal Disorders. Gastroenterology. 2016 Mar 25:S0016-5085(16)00175-X 10.1053/j.gastro.2016.02.009. doi: 10.1053/j.gastro.2016.02.009. Online ahead of print.

  PMID: 27144630 BACKGROUND

• Gao R, Tao Y, Zhou C, Li J, Wang X, Chen L, Li F, Guo L. Exercise therapy in patients with constipation: a systematic review and meta-analysis of randomized controlled trials. Scand J Gastroenterol. 2019 Feb;54(2):169-177. doi: 10.1080/00365521.2019.1568544. Epub 2019 Mar 7.

  PMID: 30843436 BACKGROUND

• Virtuoso JF, Menezes EC, Mazo GZ. Effect of Weight Training with Pelvic Floor Muscle Training in Elderly Women with Urinary Incontinence. Res Q Exerc Sport. 2019 Jun;90(2):141-150. doi: 10.1080/02701367.2019.1571674. Epub 2019 Apr 4.

  PMID: 30945991 BACKGROUND

• Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.

  PMID: 10522604 BACKGROUND

• Sadowy AM, Brouwer HL, Finseth DL, Hagener KM, Lawrence AE, Hollman JH. Development of a Pelvic Floor Muscle Coordination Scale. Journal of Women's Health Physical Therapy. 2010;34(3):81-8.

  BACKGROUND

• Gosling J, Plumb A, Taylor SA, Cohen R, Emmanuel AV. High-resolution anal manometry: Repeatability, validation, and comparison with conventional manometry. Neurogastroenterol Motil. 2019 Jun;31(6):e13591. doi: 10.1111/nmo.13591.

  PMID: 31094054 BACKGROUND

• Kaushal JN, Goldner F. Validation of the digital rectal examination as an estimate of anal sphincter squeeze pressure. Am J Gastroenterol. 1991 Jul;86(7):886-7.

  PMID: 2058632 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.

  PMID: 16036506 BACKGROUND

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kuan-Yin Lin
• Organization: National Cheng Kung University

10802003@gs.ncku.edu.tw

06-2353535

Study Officials

• Kuan-Yin Lin, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: January 1, 2021
• Primary Completion: March 23, 2022
• Study Completion: July 31, 2022
• Last Updated: August 2, 2024
• Results First Posted: August 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)