Kegel Exercises Prior to Strength Training to Improvestress Urinary Incontinence
Primary Purpose
Urinary Incontinence,Stress
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
strength training program
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence,Stress
Eligibility Criteria
Inclusion Criteria:
- being female
- over eighteen years of age
- suffer from stress urinary incontinence
- did not perform Kegel exercises
- had no experience in regular resistance/strength training
- completed a physical activity readiness questionnaire (PAR-Q) form.
Exclusion Criteria:
- pregnancy, breastfeeding
Sites / Locations
- Charles Darwin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
intervention group during study
control group during study
Arm Description
all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats. They had all completed a program of Kegel exercise prior.
all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats
Outcomes
Primary Outcome Measures
incontinence severity index (ISI) tool
questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence
incontinence severity index (ISI) tool
questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence
pelvic floor muscle strength
physiotherapist report from digital palpation and perineometry
pelvic floor muscle strength
physiotherapist report from digital palpation and perineometry
Secondary Outcome Measures
Full Information
NCT ID
NCT05527639
First Posted
August 26, 2022
Last Updated
August 4, 2023
Sponsor
Charles Darwin University
1. Study Identification
Unique Protocol Identification Number
NCT05527639
Brief Title
Kegel Exercises Prior to Strength Training to Improvestress Urinary Incontinence
Official Title
Does a Kegel Exercise Program Prior to Resistance Training Reduce the Risk of Stress Urinary Incontinence?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2019 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles Darwin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This comparative pre-post intervention study investigates the feasibility and benefits of Kegel exercises amongst incontinent women, prior to commencing resistance training, to reduce the risk of stress urinary incontinence compared to a group of women without prior Kegel exercises.
Detailed Description
The aim of the study is to determine whether a program of Kegel exercises prior to a resistance training program will result in reduction of stress urinary incontinence and whether this should be prescribed to incontinent women prior to performing resistance training. It is hypothesized that performing kegel exercises prior to resistance training would improve pelvic floor muscle strength and reduces the odds of experiencing SUI during resistance training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence,Stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A comparative study using data from 2 separate studies. Data used for the resistance training (RT) group from a foundational single cohort that investigated impact of RT on stress urinary incontinence (SUI) in a group of women participating in a RT program who had not previously done Kegel exercises (KE). New data for the KE+RT group was from 2 consecutive studies where the women completed a program of supervised / unsupervised KE. These 19 women took part in 12 weeks of RT to compare against the KE group. The findings of two separate studies in which the effect of RT on SUI and pelvic floor muscle strength was compared between women who completed 12 weeks of RT with or without prior KE. The RT group consisted of 14 women who did not have an experience in RT or KE and completed 12 weeks of RT. Women in the KE plus RT group (n=19) completed 12 weeks of Kegel exercise under the supervision of a qualified pelvic floor specialist; then completed the identical RT program as the RT group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group during study
Arm Type
Other
Arm Description
all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats. They had all completed a program of Kegel exercise prior.
Arm Title
control group during study
Arm Type
Other
Arm Description
all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats
Intervention Type
Behavioral
Intervention Name(s)
strength training program
Intervention Description
12-weeks of strength training consisting of warm ups, dead-lifts, squats and cool down exercises
Primary Outcome Measure Information:
Title
incontinence severity index (ISI) tool
Description
questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence
Time Frame
Week 0
Title
incontinence severity index (ISI) tool
Description
questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence
Time Frame
Week 12
Title
pelvic floor muscle strength
Description
physiotherapist report from digital palpation and perineometry
Time Frame
week 0
Title
pelvic floor muscle strength
Description
physiotherapist report from digital palpation and perineometry
Time Frame
week 12
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
must be female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
being female
over eighteen years of age
suffer from stress urinary incontinence
did not perform Kegel exercises
had no experience in regular resistance/strength training
completed a physical activity readiness questionnaire (PAR-Q) form.
Exclusion Criteria:
pregnancy, breastfeeding
Facility Information:
Facility Name
Charles Darwin University
City
Darwin
State/Province
Northern Territory
ZIP/Postal Code
0909
Country
Australia
12. IPD Sharing Statement
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Kegel Exercises Prior to Strength Training to Improvestress Urinary Incontinence
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