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

Sponsor
National Cheng Kung University (Other)
Overall Status
Completed
CT.gov ID
NCT04351750
Collaborator
(none)
33
Enrollment
1
Location
3
Arms
14.8
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: general exercise
  • Other: pelvic floor muscle training
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence: a Randomized Controlled Trial
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
May 24, 2021
Actual Study Completion Date :
May 24, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: high-intensity group

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
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.

Other: pelvic floor muscle training
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.
Experimental: low-intensity group

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
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.

Other: pelvic floor muscle training
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.
Active Comparator: control group

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

Other: pelvic floor muscle training
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.

Outcome Measures

Primary Outcome Measures

  1. The change of pelvic floor muscle function measured by digital palpation from baseline [8 weeks]

  2. The change of pelvic floor muscle function measured by manometry from baseline [8 weeks]

Secondary Outcome Measures

  1. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [8 weeks]

    The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form will be used to assess the severity of UI symptoms. The total score ranges from 0 to 21; a higher score indicates greater severity.

  2. International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life [8 weeks]

    The International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life will be used to evaluate quality of life in UI patients. The total score ranges from 19 to 76. A higher score indicates greater impact on quality of life.

  3. International Prostate Symptom Score [8 weeks]

    The International Prostate Symptom Score will be used to evaluate the severity of lower urinary tract symptoms. The total score ranges from 0 to 35. A higher score indicates greater severity.

  4. 3-day bladder diary [8 weeks]

  5. International Physical Activity Questionnaire [8 weeks]

    The International Physical Activity Questionnaire will be used to measure participants' physical activity levels. A higher score indicates a greater physical activity levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng Kung University Tainan Taiwan 704

Sponsors and Collaborators

  • National Cheng Kung University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Kuan-Yin Lin, Assistant professor, National Cheng Kung University
ClinicalTrials.gov Identifier:
NCT04351750
Other Study ID Numbers:
  • A-BR-108-091
First Posted:
Apr 17, 2020
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Muscle Weakness
Urinary Incontinence
Enuresis

Study Results

No Results Posted as of Oct 26, 2021