NCT05506579

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

August 16, 2022

Last Update Submit

May 20, 2025

Conditions

Keywords

Overuse InjuryUrinary IncontinenceRhythmic GymnasticsFemale athletes

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

  • 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.

    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)

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

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

  • Self-experienced effect and progress related to UI

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

Study Arms (2)

Intervention group

EXPERIMENTAL

Exercises 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.

Other: Exercises for knees, lower back, hip/groin and pelvic floor muscles in an expanded warm up program

Control group

NO INTERVENTION

No intervention.

Interventions

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.

Intervention group

Eligibility Criteria

Age12 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsRhythmic gymnastics is a female sport in Norway. Hence, the study will only include female gymnasts.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0863, Norway

Location

Related Publications (18)

  • 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.

    PMID: 32868315BACKGROUND
  • 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.

    PMID: 31484216BACKGROUND
  • 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.

    PMID: 1509229BACKGROUND
  • 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.

    PMID: 15911600BACKGROUND
  • 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.

    PMID: 32060142BACKGROUND
  • 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.

    PMID: 19941278BACKGROUND
  • 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.

    PMID: 31820378BACKGROUND
  • 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.

    PMID: 29552736BACKGROUND
  • 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.

    PMID: 29654349BACKGROUND
  • 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.

    PMID: 18224267BACKGROUND
  • 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.

    PMID: 11999199BACKGROUND
  • 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.

    PMID: 19000097BACKGROUND
  • 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.

    PMID: 30288727BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 15227649BACKGROUND
  • Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

    PMID: 20046623BACKGROUND
  • Gram MCD, Fagerland MW, Bo K. Pelvic floor muscle training by competitive rhythmic gymnasts at regular training sessions did not reduce urinary incontinence: a cluster-randomised trial. J Physiother. 2025 Apr;71(2):117-124. doi: 10.1016/j.jphys.2025.03.006. Epub 2025 Apr 1.

  • Gram MCD, Fagerland MW, Bo K. Efficacy of a Rhythmic Gymnastics-Specific Injury Prevention Program: An Assessor-Blinded Cluster-Randomized Controlled Trial. Scand J Med Sci Sports. 2025 Feb;35(2):e70022. doi: 10.1111/sms.70022.

MeSH Terms

Conditions

Cumulative Trauma DisordersUrinary Incontinence

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and InjuriesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kari Bø, PhD

    Norwegian School of Sport Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, Physical therapist, Exercise scientist

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

August 22, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations