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Pelvic Floor Muscle Training in Female CrossFit and Functional Fitness Exercisers

Primary Purpose

Stress Urinary Incontinence, Pelvic Floor Disorders, Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers
Sponsored by
Norwegian School of Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18
  • ≥ 6 months of consistent participation in CrossFit or functional fitness training
  • Participating in ≥ 3 sessions of cross-fit training per week
  • Self-reported SUI and a total score on ICIQ-UI-SF of ≥ 3. A change of the ICIQ-UI-SF score of 2.5 has been identified to be the minimal important difference (MID) and 1.58 as between-treatment MID (Nystrom et al., 2015).
  • No musculoskeletal injuries for the past 6 months with negative effect on training participation

Exclusion Criteria:

  • Ongoing pregnancy, or planning to get pregnant during the intervention period
  • History of hysterectomy or pelvic surgery to correct UI or POP
  • History of musculoskeletal injuries for the past 6 months with negative effect on training participation
  • Parous women who are ≤12 months post-partum

Sites / Locations

  • Norwegian School of Sport Sciences, Department of Sport MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

16 weeks home-based PFM training program with weekly follow-up by a physiotherapist

No intervention

Outcomes

Primary Outcome Measures

The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
A reliable and valid questionnaire assessing self-reported prevalence, amount of leakage, bother and type of UI. A change in ICIQ-UI-SF score of 1.58 points will be considered as between-treatment minimum important difference.

Secondary Outcome Measures

Pelvic Floor Muscle Resting Pressure
Measurement of vaginal resting pressure will be measured with manometry. A high precision pressure transducer connected to a vaginal balloon catheter (Camtech AS, Sandvika Norway) will be used. The method has demonstrated good intra-observer reliability (intraclass correlation coefficient: >90). Vaginal resting pressure will be recorded in cmH2O.
Pelvic Floor Muscle Strength
We will use manometry to assess pressure rise generated during a maximum voluntary contraction of the PFM (PFM strength). A high precision pressure transducer connected to a vaginal balloon catheter (Camtech AS, Sandvika Norway) will be used. The method has demonstrated good intra-observer reliability (intraclass correlation coefficient: >90). Average peak pressure from 3 different PFM maximum voluntary contraction will be used to report PFM strength, recorded in cmH2O.
Pelvic Floor Muscle Endurance
We will use manometry to assess the participants ability to perform a 10 seconds sustained PFM contraction (PFM endurance). A high precision pressure transducer connected to a vaginal balloon catheter (Camtech AS, Sandvika Norway) will be used. The method has demonstrated good intra-observer reliability (intraclass correlation coefficient: >90). PFM endurance will be reported as the area under the pressure curve in cmH2O multiplied by the duration of the contraction (10 s).
Self-Efficacy Scale for Practicing Pelvic Floor Exercises (SESPPFE)
The participants will be asked to rate their self-efficacy (from 0-100) on 16 different items regarding PFM training. The scale have been tested to have good internal consistency (α = 0.92) and acceptable reliability (rho = 0.89).
Anal incontinence
Questions from patient-reported outcome measures (PROM) with Grade A recommendation from the International Consensus on Incontinence 2017 will be used to assess prevalence and bother of anal incontinence (ICIQ-B)
Pelvic Organ Prolapse
Questions from patient-reported outcome measures (PROM) with Grade A recommendation from the International Consensus on Incontinence 2017 will be used to assess prevalence and bother of pelvic organ prolapse (ICIQ-VS).
Patient Global Impression of Improvement (PGI-I) Scale
The participants will be asked to rate their perceived change of the condition. A validated 7-point scale with response choices ranging from "very much better" to "very much worse" will be used.

Full Information

First Posted
April 4, 2022
Last Updated
August 17, 2022
Sponsor
Norwegian School of Sport Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05341024
Brief Title
Pelvic Floor Muscle Training in Female CrossFit and Functional Fitness Exercisers
Official Title
Effect of Pelvic Floor Muscles Training on Symptoms, Bother and Amount of Stress Urinary Incontinence in Female CrossFit and Functional Fitness Exercisers. An Assessor Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian School of Sport Sciences

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
There is a high prevalence of urinary incontinence (UI) among female athletes and exercisers, especially in sports including high impact activities and heavy weightlifting. CrossFit and functional fitness is a popular exercise form, including a combination of heavy lifting and high impact activities at high intensities. In several recent studies, high prevalence rates of UI have been reported among female CrossFit/functional fitness exercisers. UI is defined as "the complaint of involuntary loss of urine". Stress urinary incontinence (SUI) is the most common type of UI and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or or sneezing or coughing". Urinary leakage during sport activities may affect athletes' and exercisers' performance, cause bother, frustration and embarrassment and furthermore lead to avoidance and cessation of sport activities. Pelvic floor muscle (PFM) training is highly effective in treating SUI in the general female population. However, evidence of the effect of PFM training in exercisers participating in high impact and heavy weightlifting activities is sparse. The purpose of this assessor-blinded randomized controlled trial (RCT) is to assess the effect of PFM training on symptoms, bother and amount of SUI in female CrossFit/functional fitness exercisers.
Detailed Description
BACKGROUND: Physical activity and exercise have well-known beneficial effects on several physical and psychological health outcomes. However, it has been proposed that regular participation in physical activity and exercise may lead to greater risk of developing pelvic floor dysfunctions (PFD) in women. The pelvic floor consists of muscles, fascia and ligaments and forms a hammock-like support at the base of the abdomino-pelvic cavity. The function of the pelvic floor is to provide support to the pelvic organs (the bladder, urethra, vagina, uterus and rectum) and to counteract all increases in intra-abdominal pressure and ground reactions forces during daily activities. Additionally, the pelvic floor facilitates intercourse, vaginal birth, storage of stool and urine and voluntary defecation and urination. A dysfunctional pelvic floor can lead to urinary and anal incontinence, pelvic organ prolapse, sexual problems and chronic pain syndromes. UI is the most common PFD, defined as "the complaint of involuntary loss of urine". SUI, urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI) are common subtypes of UI. In women, SUI accounts for approximately half of all incontinence types and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or on sneezing or coughing". UUI is defined as the "complaint of involuntary loss of urine associated with urgency" and MUI as "complaints of both stress and urgency urinary incontinence". High prevalence rates of UI among both parous and nulliparous female athletes and exercisers have been reported in several cross-sectional studies. The prevalence rates varies between 0-80% with the highest prevalence found in high impact sports such as trampoline jumping, gymnastics and strengths sports with high increases in intraabdominal pressure (e.g. powerlifting). CrossFit and functional fitness, which are trending exercise forms, includes a combination of heavy lifting and high impact activities at high intensities. High prevalence of UI among CrossFit/functional fitness exercisers has been reported in several recent cross-sectional studies, ranging from 41-84%. Leakage during sport and exercise may affect performance and cause bother, frustration and embarrassment, and may further lead to avoidance or cessation of sport and exercise. To date, there is level 1 evidence and grade A recommendation for PFM training alone to be first line treatment for SUI, MUI and pelvic organ prolapse in the general female population. In addition, PFM training is highly effective as primary prevention; pregnant continent women who exercise the PFM are at 62% less risk of UI in late pregnancy and 29% less risk of UI 3-6 months postpartum. Evidence of the effect of PFM training in athletes or strenuous exercisers is sparse. In one study on female soldiers and two small case series in female athletes and exercisers, PFM training led to reduced symptoms of UI. However, none of these studies included a non-treated control group and the internal validity is therefore low. To our knowledge, only one RCT has assessed effects of PFM training on SUI in athletes. Female volleyball players (n=16) who followed a PFM training program had significant improvements of SUI compared to a control group (n=16). Based on today's knowledge we do not know whether PFM training is effective in strenuous exposed to excessive impact and increases in intraabdominal pressure during CrossFit- and functional fitness activities. Given the high impact on the pelvic floor in these exercisers, it is presumed that they need much better pelvic floor muscle function than non-exercisers. On the other hand, these exercisers may be motivated for regular training. Strength training of the PFM, if proven effective, may be easily incorporated in their basic training regimens both as prevention and treatment strategies of SUI. AIMS: The aim of this RCT is to assess the effect of PFM training on symptoms, bother and amount of SUI among female CrossFit and functional fitness exercisers. STUDY DESIGN AND METHODS: To recruit participants, we will contact CrossFit boxes and functional fitness clubs in or near Oslo. Social media platforms (such as Facebook, Instagram) will also be used. The study is an assessor-blinded RCT evaluating the effect of PFM training on SUI in CrossFit and functional fitness exercisers. At baseline, a pelvic floor muscle assessment (resting pressure, strength and endurance) will be performed of all participants. In addition, the participants will respond to an electronic questionnaire, measuring self-reported symptoms of UI and bother. The participants will be randomly assigned to either a PFM training group (EG) or a control group (CG) with no intervention. The intervention consists of a daily home-based PFM training program with weekly follow-up by a physiotherapist. After a 16-week intervention period, all participants will perform a post-test including the same previous mentioned outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Pelvic Floor Disorders, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
16 weeks home-based PFM training program with weekly follow-up by a physiotherapist
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers
Intervention Description
The intervention will consist of a home-based PFM training program with weekly follow-up by phone by a physiotherapist. Before commencing PFM training, the participants in the intervention group will have an individual session with a physiotherapist including thorough teaching on how to perform a correct PFM contraction (clinical exams of pelvic floor muscle function by observation and vaginal digital palpation) and instructions on how to perform the training program. The program consists of 3 sets of 8-12 maximum contractions per day. An electronic app (Athlete monitoring) will be used to assess adherence to the program. The participants will be asked to register their training sessions in a personal account. A reminder to adhere to the program will be sent by phone. The training period will be 16 weeks and the exercises will take approximately 10 minutes per day to perform.
Primary Outcome Measure Information:
Title
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
Description
A reliable and valid questionnaire assessing self-reported prevalence, amount of leakage, bother and type of UI. A change in ICIQ-UI-SF score of 1.58 points will be considered as between-treatment minimum important difference.
Time Frame
Change in total score from baseline at four months
Secondary Outcome Measure Information:
Title
Pelvic Floor Muscle Resting Pressure
Description
Measurement of vaginal resting pressure will be measured with manometry. A high precision pressure transducer connected to a vaginal balloon catheter (Camtech AS, Sandvika Norway) will be used. The method has demonstrated good intra-observer reliability (intraclass correlation coefficient: >90). Vaginal resting pressure will be recorded in cmH2O.
Time Frame
Change in pressure value from baseline at four months
Title
Pelvic Floor Muscle Strength
Description
We will use manometry to assess pressure rise generated during a maximum voluntary contraction of the PFM (PFM strength). A high precision pressure transducer connected to a vaginal balloon catheter (Camtech AS, Sandvika Norway) will be used. The method has demonstrated good intra-observer reliability (intraclass correlation coefficient: >90). Average peak pressure from 3 different PFM maximum voluntary contraction will be used to report PFM strength, recorded in cmH2O.
Time Frame
Change in pressure value from baseline at four months
Title
Pelvic Floor Muscle Endurance
Description
We will use manometry to assess the participants ability to perform a 10 seconds sustained PFM contraction (PFM endurance). A high precision pressure transducer connected to a vaginal balloon catheter (Camtech AS, Sandvika Norway) will be used. The method has demonstrated good intra-observer reliability (intraclass correlation coefficient: >90). PFM endurance will be reported as the area under the pressure curve in cmH2O multiplied by the duration of the contraction (10 s).
Time Frame
Change in pressure value from baseline at four months
Title
Self-Efficacy Scale for Practicing Pelvic Floor Exercises (SESPPFE)
Description
The participants will be asked to rate their self-efficacy (from 0-100) on 16 different items regarding PFM training. The scale have been tested to have good internal consistency (α = 0.92) and acceptable reliability (rho = 0.89).
Time Frame
At baseline in both groups. Participants in the intervention group will also be asked to answer the questionnaire again within the first month of the intervention period
Title
Anal incontinence
Description
Questions from patient-reported outcome measures (PROM) with Grade A recommendation from the International Consensus on Incontinence 2017 will be used to assess prevalence and bother of anal incontinence (ICIQ-B)
Time Frame
Change in score from baseline at four months
Title
Pelvic Organ Prolapse
Description
Questions from patient-reported outcome measures (PROM) with Grade A recommendation from the International Consensus on Incontinence 2017 will be used to assess prevalence and bother of pelvic organ prolapse (ICIQ-VS).
Time Frame
Change in score from baseline at four months
Title
Patient Global Impression of Improvement (PGI-I) Scale
Description
The participants will be asked to rate their perceived change of the condition. A validated 7-point scale with response choices ranging from "very much better" to "very much worse" will be used.
Time Frame
Post-test after a 4-months intervention period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 ≥ 6 months of consistent participation in CrossFit or functional fitness training Participating in ≥ 3 sessions of cross-fit training per week Self-reported SUI and a total score on ICIQ-UI-SF of ≥ 3. A change of the ICIQ-UI-SF score of 2.5 has been identified to be the minimal important difference (MID) and 1.58 as between-treatment MID (Nystrom et al., 2015). No musculoskeletal injuries for the past 6 months with negative effect on training participation Exclusion Criteria: Ongoing pregnancy, or planning to get pregnant during the intervention period History of hysterectomy or pelvic surgery to correct UI or POP History of musculoskeletal injuries for the past 6 months with negative effect on training participation Parous women who are ≤12 months post-partum
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kari Bø, PhD
Phone
+47 23 26 20 08
Email
kari.bo@nih.no
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Lindquist Skaug, MSc
Phone
+47 40 60 99 16
Email
k.l.skaug@nih.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari Bø, PhD
Organizational Affiliation
Norwegian School of School of Sport Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Norwegian School of Sport Sciences, Department of Sport Medicine
City
Oslo
ZIP/Postal Code
0863
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kari Bø, Phd
First Name & Middle Initial & Last Name & Degree
Kristina L. Skaug, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
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Pelvic Floor Muscle Training in Female CrossFit and Functional Fitness Exercisers

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