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Overuse InjuryNCT05506579

Prevention and Treatment of Injuries and Urinary Incontinence Among Norwegian Rhythmic Gymnasts

A study testing Exercises for knees, lower back, hip/groin and pelvic floor muscles in an expanded warm up program in people with Overuse Injury and Urinary Incontinence, run by Norwegian School of Sport Sciences at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Overuse injuries are common among competitive Norwegian rhythmic gymnasts with a mean weekly prevalence of 37% [95% CI: 36 - 39%] and incidence of 4.2 new overuse injuries [95% CI: 3.6 - 4.9] per gymnast per year (Gram, M., Clarsen, B., \& Bø, K., 2021). Read more about this study

Who is it for?
Ages 12 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Overuse Injury, Urinary Incontinence
What is being tested?
Exercises for knees, lower back, hip/groin and pelvic floor muscles in an expanded warm up program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
1 siteNorway
Study dates
22 Aug 2022to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • All rhythmic gymnastics clubs that are members of the Norwegian Gymnastics Federation and have gymnasts fulfilling the inclusion criteria will be invited to participate.
  • Female rhythmic gymnasts ≥12 years of age training ≥3 days per week

Who cannot join

  • Female rhythmic gymnasts <12 years of age training <3 days per week

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Norwegian School of Sport Sciences

    Oslo, 0863

Other trials in Norway

About this study

Official title: Musculoskeletal Injuries, Pelvic Floor Dysfunctions and Menstrual Irregularities in Norwegian Rhythmic Gymnasts and Dancers - Observational and Cluster Randomized Controlled Studies

Overuse injuries are common among competitive Norwegian rhythmic gymnasts with a mean weekly prevalence of 37% [95% CI: 36 - 39%] and incidence of 4.2 new overuse injuries [95% CI: 3.6 - 4.9] per gymnast per year (Gram, M., Clarsen, B., \& Bø, K., 2021). The knees, lower back and hip/groin were the most common injury locations. It has been postulated that reduced physical capacity (e.g strength, flexibility, stability) in the knees, lower back and hip/groin can increase the risk of injuries in rhythmic gymnastics.

In addition, more than 30% of the Norwegian rhythmic gymnasts experience urinary incontinence (UI), and 70% reported that UI negatively affected sports performance (Gram, M., \& Bø, K., 2020). Few of the rhythmic gymnasts had any knowledge about the pelvic floor.

Hence, this assessor blinded cluster randomized controlled trial aims to find out whether the implementation of exercises targeting reduced physical capacity and pelvic floor dysfunction can prevent/reduce the prevalence of overuse injuries and UI.

Read the detailed description

BACKGROUND

Norwegian rhythmic gymnasts have high prevalence and incidence of overuse injuries. Previous research on risk factors related to injuries in rhythmic gymnastics (RG) has implied that high weekly training load, hypermobility, poor technic and inappropriate training load increase the risk of injuries. A prospective study also found that previous injury increased the risk of injuries substantially (Gram, M., Clarsen, B., \& Bø, K., 2021). Hence, injury prevention interventions should start at an early age to avoid the first injury. In addition, since the aetiology and mechanisms of injuries are multifactorial, with a well described complex interaction of internal and external risk factors making a gymnast more or less prone to sustain an injury, there might be a need to assess some internal risk factors more thoroughly. The modifiable internal risk factor physical capacity, e.g. strength, flexibility, stability, might be of particular interest, since lack of physical capacity can be thought of as a potential underlying cause in all of the above-mentioned risk factors. In addition, it is well known how persistent lack of physical capacity relative to the requirements in a sport might lead to injuries. With knees, lower back and hip/groin as the most commonly reported injury locations, clinical assessment of strength, flexibility and stability in these locations has been conducted in a cross-sectional study before this randomized controlled trial (RCT). Reduced physical capacity revealed in the cross-sectional study will be targeted/brought forward in the exercise program in the RCT.

The most common types of pelvic floor dysfunctions (PFD) are urinary incontinence (UI), anal incontinence (AI) and pelvic organ prolapse (POP). UI has high prevalence among female athletes participating in sports including jumping and running (high impact). A prevalence of 80% was found in young, nulliparous high-level trampoline jumpers in Sweden (Eliasson et.al., 2008). The prevalence among Norwegian rhythmic gymnasts was >30%, while Thyssen et.al. found that 56% of female Danish artistic gymnasts and 43% of dancers reported UI. UI negatively affects sports performance, and symptoms at young age is a risk factor of future UI developing during pregnancy and after childbirth. Hence, interventions toward prevention and treatment is necessary. While strength training of the pelvic floor muscles has 1A level of evidence/recommendation to treat UI in the general female population, and has no known adverse effects, there is little knowledge of this among young female athletes and dancers. Search on PubMed revealed only one RCT assessing the effect of pelvic floor muscle training on UI in female athletes. Ferreira et.al. randomized 32 female volleyball players to 3 months of pelvic floor muscle training or control, and found statistically significant improvement in the exercise group in frequency of leakage and urine loss measured during physical activity(p< 0.001). Hence, there seem to be a potential for prevention and treatment also in athletes exposed to heavy load towards the pelvic floor.

AIMS

The aims of this RCT are to investigate if implementation of prophylactic exercises targeting reduced capacity and pelvic floor dysfunction can prevent/lower the prevalence of overuse injuries and UI among Norwegian rhythmic gymnasts.

STUDY DESIGN AND METHODS

All rhythmic gymnastics clubs that are members of the Norwegian Gymnastics Federation and have gymnasts fulfilling the inclusion criteria will be invited to participate. The clubs are then randomly allocated to either an exercise or control group. Randomization will be provided by a person not involved in assessments of outcome.

All gymnasts in both groups will answer the "Oslo Sports Trauma Research Center Questionnaire on Health Problems" (OSTRC-H2) at baseline (including a part with background questions) and once each month during the intervention period. In addition, the gymnasts will answer the "International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form" (ICIQ-UI-SF) before and after the intervention period. After the intervention, the intervention group will answer the Global rating of change (GRC), a numerical 11-point scale to assess self-experienced effect and progress related to overuse injuries and UI.

Being tested
Exercises for knees, lower back, hip/groin and pelvic floor muscles in an expanded warm up program
Keywords
Overuse Injury, Urinary Incontinence, Rhythmic Gymnastics, Female athletes
Medical subject headings
Cumulative Trauma Disorders, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercises for knees, lower back, hip/groin and pelvic floor muscles in an expanded warm up programOther

    Rhythmic gymnastics clubs allocated to the intervention group will be visited by a physiotherapist (the PhD candidate), which will perform thorough teaching of coaches and gymnasts on how to perform the exercises in the expanded warm up program. During the same visit, before commencing PFMT, the gymnasts will have an individual session were a portable 2D ultrasound machine (GE Healthcare -Logiq e R7, GE>12L-RS - 5-13 MHz Wideband Linear Probe) will be used to teach and assess ability to perform a correct PFM contraction. The probe is placed suprapubically and provides concurrent visible biofeedback of the PFM contraction. Adherence to the intervention will be registered weekly by the coach in a training diary and asked for as an additional question in the monthly OSTRC-H2 sent to the gymnasts. Reminders will be sent by phone to the coaches every week. To assure proper execution and motivation, the PhD candidate will perform one extra visit midterm.

Study groups in NCT05506579
Study groupRoleWhat they receive
Intervention groupExperimentalExercises for knees, lower back and hip/groin in an expanded warm up program. In addition, the warm up program will include pelvic floor muscle training (PFMT). The warm up program will in total take approximately 12-15 minutes to conduct each training.
Receives: Other: Exercises for knees, lower back, hip/groin and pelvic floor muscles in an expanded warm up program
Control groupNo interventionNo intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in prevalence of overuse injuries in the knees, lower back and hip/groin

    The Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC-H2) is a valid questionnaire to assess prevalence and severity of injuries in different anatomical areas.

    Measured: The gymnasts in both groups will answer the OSTRC-H2 at baseline (October 2022) and one time each month throughout the intervention period (last registration in June 2023)

  2. Reduction in prevalence and bother of UI

    The International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI-SF) is a reliable and valid questionnaire assessing prevalence, amount of leakage, bother and type of UI.

    Measured: The gymnasts in both groups will answer the ICIQ-UI-SF one time at baseline (October 2022) and one time when the intervention period has ended (June 2023)

Secondary outcomes (2)

  1. Self-experienced effect and progress related to overuse injuries in the knees, lower back and hip/groin

    Assessed by Global rating of change (GRC), a numerical 11-point scale, which has shown good test-retest reliability (ICC = 0.9).

    Measured: The gymnasts in the intervention group will answer the GRC on time when the intervention period has ended (June 2023)

  2. Self-experienced effect and progress related to UI

    Assessed by Global rating of change (GRC), a numerical 11-point scale, which has shown good test-retest reliability (ICC = 0.9).

    Measured: The gymnasts in the intervention group will answer the GRC one time when the intervention period has ended (June 2023)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2022
  2. Study start22 Aug 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
This is an assessor blinded cluster randomized controlled trial with rhythmic gymnastics clubs as the unit of randomization. Two different interventions (preventive exercises for the knees, lower back and hip/groin and PFMT) for two different conditions (overuse injuries and UI) are combined in this design. After inclusion, all rhythmic gymnastics clubs will be randomly allocated 1:1 to preventive exercises for knee, lower back and hip/groin and PFMT or a control group with no intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05506579
Sponsor's protocol ID
MCDG2022
Status last verified
May 2025
First submitted
16 Aug 2022
Last updated
22 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gram MCD, Clarsen B, Bo K. Injuries and illnesses among competitive Norwegian rhythmic gymnasts during preseason: a prospective cohort study of prevalence, incidence and risk factors. Br J Sports Med. 2021 Feb;55(4):231-236. doi: 10.1136/bjsports-2020-102315. Epub 2020 Aug 31.

    PubMed 32868315

  • Gram MCD, Bo K. High level rhythmic gymnasts and urinary incontinence: Prevalence, risk factors, and influence on performance. Scand J Med Sci Sports. 2020 Jan;30(1):159-165. doi: 10.1111/sms.13548. Epub 2019 Sep 30.

    PubMed 31484216

  • van Mechelen W, Hlobil H, Kemper HC. Incidence, severity, aetiology and prevention of sports injuries. A review of concepts. Sports Med. 1992 Aug;14(2):82-99. doi: 10.2165/00007256-199214020-00002.

    PubMed 1509229

  • Bahr R, Krosshaug T. Understanding injury mechanisms: a key component of preventing injuries in sport. Br J Sports Med. 2005 Jun;39(6):324-9. doi: 10.1136/bjsm.2005.018341.

    PubMed 15911600

  • Clarsen B, Bahr R, Myklebust G, Andersson SH, Docking SI, Drew M, Finch CF, Fortington LV, Haroy J, Khan KM, Moreau B, Moore IS, Moller M, Nabhan D, Nielsen RO, Pasanen K, Schwellnus M, Soligard T, Verhagen E. Improved reporting of overuse injuries and health problems in sport: an update of the Oslo Sport Trauma Research Center questionnaires. Br J Sports Med. 2020 Apr;54(7):390-396. doi: 10.1136/bjsports-2019-101337. Epub 2020 Feb 14.

    PubMed 32060142

  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.

    PubMed 19941278

  • 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.

    PubMed 31820378

  • de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.

    PubMed 29552736

  • Teixeira RV, Colla C, Sbruzzi G, Mallmann A, Paiva LL. Prevalence of urinary incontinence in female athletes: a systematic review with meta-analysis. Int Urogynecol J. 2018 Dec;29(12):1717-1725. doi: 10.1007/s00192-018-3651-1. Epub 2018 Apr 13.

    PubMed 29654349

  • Eliasson K, Edner A, Mattsson E. Urinary incontinence in very young and mostly nulliparous women with a history of regular organised high-impact trampoline training: occurrence and risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):687-96. doi: 10.1007/s00192-007-0508-4. Epub 2008 Jan 26.

    PubMed 18224267

  • Thyssen HH, Clevin L, Olesen S, Lose G. Urinary incontinence in elite female athletes and dancers. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(1):15-7. doi: 10.1007/s001920200003.

    PubMed 11999199

  • Bo K, Sundgot-Borgen J. Are former female elite athletes more likely to experience urinary incontinence later in life than non-athletes? Scand J Med Sci Sports. 2010 Feb;20(1):100-4. doi: 10.1111/j.1600-0838.2008.00871.x.

    PubMed 19000097

  • Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.

    PubMed 30288727

  • Ferreira, S., Ferreira, M., Carvalhais, A., Santos, P. C., Rocha, P., & Brochado, G. (2014). Reeducation of pelvic floor muscles in volleyball athletes. Revista da Associação Médica Brasileira, 60, 428-433.

  • 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.

    PubMed 15227649

Questions about this trial

What is this clinical trial studying?

A study testing Exercises for knees, lower back, hip/groin and pelvic floor muscles in an expanded warm up program in people with Overuse Injury and Urinary Incontinence, run by Norwegian School of Sport Sciences at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in prevalence of overuse injuries in the knees, lower back and hip/groin (time frame: The gymnasts in both groups will answer the OSTRC-H2 at baseline (October 2022) and one time each month throughout the intervention period (last registration in June 2023)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05506579, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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