Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence

NCT04351750 | Completed Results

• 1 other identifier: A-BR-108-091
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary incontinence (UI) symptoms are highly prevalent among women, and menopause is one of the risk factors for UI. During the menopausal transition, not only the hormonal secretion is changed but also the level of physical activity is affected. The time spent on physical activity is reduced in postmenopausal women. Studies have shown that physical activity acts in a bidirectional manner, exerting either a preventive or an aggravating effect on urinary incontinence. Individuals with sedentary lifestyle and insufficient physical activity (\< 150 min/week) are at risk of developing UI, and regular physical activity exerts a protective effect in preventing UI, but the optimal type, duration, and intensity of exercise for the female older adult population remain unknown. In addition, objective measurements of pelvic floor muscle function is needed as the use of self-reported measures may cause response bias. The aim of the study is to investigate the effect of different intensity of exercise on pelvic floor muscle function and HRQoL in postmenopausal women with UI. The investigators hypothesize that (a) both high- and low-intensity physical activities can improve pelvic floor muscle strength and HRQoL in postmenopausal women with UI, and (b) the improvement in high-intensity group is higher than that in low-intensity group. A randomized trial will be conducted to compare the effect of different exercise intensity on pelvic floor muscle function in postmenopausal women with urinary incontinence (n=90).

Conditions

Urinary Incontinence; Pelvic Floor Muscle Weakness

Outcome Measures

Primary Outcomes (2)

• Pelvic Floor Muscle Function Measured by Digital Palpation

  Pelvic floor muscle function (muscle strength) was measured through digital palpation. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction (MVC). The result was recorded using the modified Oxford grading scale, a six-point system with higher score indicated stronger muscle strength (0 = no contraction, 1 = flicker, 2 = weak, 3 = moderate with lift, 4 = good with lift, 5 = strong with lift).

  absolute values at 8 weeks

• Pelvic Floor Muscle Function Measured by Manometry

  The manometry supplied by Laborie® Biofeedback and Stimulation System was used to assess vaginal squeeze pressure, and the unit of pressure was registered in millimeter of mercury (mmHg). The participants were asked to perform 3 times of MVC, holding for 5 seconds with 5 seconds interval resting time, and the maximum value among the three MVC was recorded. The muscle strength was calculated as the value of MVC minus resting tone.

  absolute values at 8 weeks

Secondary Outcomes (5)

• International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

  absolute values at 8 weeks

• International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life

  absolute values at 8 weeks

• International Prostate Symptom Score

  absolute values at 8 weeks

• 3-day Bladder Diary

  absolute values at 8 weeks

• International Physical Activity Questionnaire

  absolute values at 8 weeks

Study Arms (3)

high-intensity group

EXPERIMENTAL

The participants will receive high-intensity general exercise and pelvic floor muscle training in high-intensity group. The intensity of aerobic exercise is 60 \~ 89% of heart rate reserve (HRR) or oxygen uptake reserve (VO2R), which is equivalent to the vigorous intensity exercise proposed in the American College of Sports Medicine (ACSM). The intensity of resistance exercise is 60\~80% of 1 repetition maximum (RM), which is equivalent to the moderate-to-vigorous intensity exercise proposed in ACSM. After finishing the general exercise, participants will receive pelvic floor muscle training.

Other: general exercise; Other: pelvic floor muscle training

low-intensity group

EXPERIMENTAL

The participants will receive low-intensity general exercise and pelvic floor muscle training in low-intensity group. The intensity of aerobic exercise is 40\~59% of HRR or VO2R, which is equivalent to the moderate intensity exercise proposed in ACSM. The intensity of resistance exercise is 40\~50% of 1RM, which is equivalent to the very light-to-light intensity exercise proposed in ACSM. After finishing the general exercise, participants will receive pelvic floor muscle training.

Other: general exercise; Other: pelvic floor muscle training

control group

ACTIVE COMPARATOR

The participants will only receive pelvic floor muscle training in control group.

Other: pelvic floor muscle training

Interventions

general exercise OTHER

The participants will receive training sessions twice a week for 8 weeks. General exercise includes aerobic exercise (stationary bike) and resistance training (thera-band, sandbags, dumbbell and swiss ball), and the intensity and progression of both aerobic and resistance exercises will be provided as recommended by the ACSM, and the exercise will individualized based on participant's HRR, 1 RM weight and Borg Scale of Perceived Exertion Scale (Borg RPE scale). An oximeter will be utilized to monitor the heart rate and SPO2 of the participants to ensure safety during the training session.

high-intensity group; low-intensity group

pelvic floor muscle training OTHER

Participants will do pelvic floor muscle training in different positions. Each session includes three sets of eight to twelve maximum voluntary contractions of pelvic floor muscle, with holding the contraction for 6 to 8 seconds, and if possible, to do three fast contractions at the end of each set.

control group; high-intensity group; low-intensity group

Eligibility Criteria

• Age: Up to 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women: amenorrhoea for longer than 12 months.
• Symptomatic UI: The questionnaire for urinary incontinence diagnosis (QUID) score \>0
• Sedentary lifestyle: \< 150 minutes of moderate-intensity aerobic physical activity throughout the week, or \< 75 minutes of vigorous-intensity aerobic physical activity throughout the week, or an equivalent combination of moderate and vigorous-intensity activity
• Able to answer the questionnaire correctly (no language barrier or cognitive problems)
• No other physical or psychological problem that would interfere participation in the study
• No concurrent outpatient rehab attendance / supervised exercise

You may not qualify if:

• Use hormone therapy
• Age \>80 y/o
• Neurological condition: Spinal cord injury, multiple sclerosis, transverse myelitis, cerebrovascular accident
• Radical surgery for pelvis, sling, and prolapse surgery
• Malignancy for bladder, urethra, uterus, ovary, cervix, and rectum
• Overflow incontinence or voiding dysfunction

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University

Tainan, 704, Taiwan

Location

Related Publications (11)

• Nygaard I, Shaw J, Egger MJ. Exploring the association between lifetime physical activity and pelvic floor disorders: study and design challenges. Contemp Clin Trials. 2012 Jul;33(4):819-27. doi: 10.1016/j.cct.2012.04.001. Epub 2012 Apr 12.

  PMID: 22521947 BACKGROUND

• Bo K, Nygaard IE. Is Physical Activity Good or Bad for the Female Pelvic Floor? A Narrative Review. Sports Med. 2020 Mar;50(3):471-484. doi: 10.1007/s40279-019-01243-1.

  PMID: 31820378 BACKGROUND

• Faleiro DJA, Menezes EC, Capeletto E, Fank F, Porto RM, Mazo GZ. Association of Physical Activity With Urinary Incontinence in Older Women: A Systematic Review. J Aging Phys Act. 2019 Dec 1;27(4):906-913. doi: 10.1123/japa.2018-0313.

  PMID: 30859902 BACKGROUND

• Akkus Y, Pinar G. Evaluation of the prevalence, type, severity, and risk factors of urinary incontinence and its impact on quality of life among women in Turkey. Int Urogynecol J. 2016 Jun;27(6):887-93. doi: 10.1007/s00192-015-2904-5. Epub 2015 Dec 5.

  PMID: 26638154 BACKGROUND

• Duval K, Prud'homme D, Rabasa-Lhoret R, Strychar I, Brochu M, Lavoie JM, Doucet E. Effects of the menopausal transition on energy expenditure: a MONET Group Study. Eur J Clin Nutr. 2013 Apr;67(4):407-11. doi: 10.1038/ejcn.2013.33. Epub 2013 Feb 20.

  PMID: 23422924 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

• Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

  PMID: 15227649 BACKGROUND

• Barry MJ, Fowler FJ Jr, O'leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT; Measurement Committee of the American Urological Association. The American Urological Association Symptom Index for Benign Prostatic Hyperplasia. J Urol. 2017 Feb;197(2S):S189-S197. doi: 10.1016/j.juro.2016.10.071. Epub 2016 Dec 22.

  PMID: 28012747 BACKGROUND

• Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9. doi: 10.1111/j.1471-0528.1997.tb11006.x.

  PMID: 9422015 BACKGROUND

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

• Li YT, Tsai YJ, Wang LY, Ou YC, Kao YL, Lin KY. The feasibility of a multimodal exercise program for sedentary postmenopausal women with urinary incontinence: A pilot randomized controlled trial. Maturitas. 2023 Jan;167:90-98. doi: 10.1016/j.maturitas.2022.10.004. Epub 2022 Oct 27.

  PMID: 36327627 DERIVED

Related Links

• What are pelvic floor safe exercises?
• International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
• International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; 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

+88662353535

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: April 14, 2020
• First Posted: April 17, 2020
• Study Start: March 1, 2020
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: March 31, 2023
• Results First Posted: March 31, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)