Pelvic Floor Muscle Training in Female CrossFit and Functional Fitness Exercisers

NCT05341024 | Completed

• 1 other identifier: KLS2022
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Pelvic Floor Disorders; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in total score from baseline at four months

Secondary Outcomes (7)

• Pelvic Floor Muscle Resting Pressure

  Change in pressure value from baseline at four months

• Pelvic Floor Muscle Strength

  Change in pressure value from baseline at four months

• Pelvic Floor Muscle Endurance

  Change in pressure value from baseline at four months

• Self-Efficacy Scale for Practicing Pelvic Floor Exercises (SESPPFE)

  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

• Anal incontinence

  Change in score from baseline at four months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers

Control Group

NO INTERVENTION

No intervention

Interventions

Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead

Study Sites (1)

Norwegian School of Sport Sciences, Department of Sport Medicine

Oslo, 0863, Norway

Location

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MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelvic Floor Disorders; 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; Pregnancy Complications

Study Officials

• Kari Bø, PhD

  Norwegian School of School of Sport Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 22, 2022
• Study Start: May 2, 2022
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)