Prevention and Treatment of Injuries and Urinary Incontinence Among Norwegian Rhythmic Gymnasts
Primary Purpose
Overuse Injury, Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercises for knees, lower back, hip/groin and pelvic floor muscels in an expanded warm up program
Sponsored by
About this trial
This is an interventional prevention trial for Overuse Injury focused on measuring Overuse Injury, Urinary Incontinence, Rhythmic Gymnastics, Female athletes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Female rhythmic gymnasts <12 years of age training <3 days per week
Sites / Locations
- Norwegian School of Sport SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
No intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT05506579
First Posted
August 16, 2022
Last Updated
November 30, 2022
Sponsor
Norwegian School of Sport Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05506579
Brief Title
Prevention and Treatment of Injuries and Urinary Incontinence Among Norwegian Rhythmic Gymnasts
Official Title
Musculoskeletal Injuries, Pelvic Floor Dysfunctions and Menstrual Irregularities in Norwegian Rhythmic Gymnasts and Dancers - Observational and Cluster Randomized Controlled Studies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 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
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 muscle function can prevent/reduce the prevalence of overuse injuries and UI.
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 capasity 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 muscle function 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overuse Injury, Urinary Incontinence
Keywords
Overuse Injury, Urinary Incontinence, Rhythmic Gymnastics, Female athletes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Other
Intervention Name(s)
Exercises for knees, lower back, hip/groin and pelvic floor muscels in an expanded warm up program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in prevalence of overuse injuries in the knees, lower back and hip/groin
Description
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.
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)
Title
Reduction in prevalence and bother of UI
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Self-experienced effect and progress related to overuse injuries in the knees, lower back and hip/groin
Description
Assessed by Global rating of change (GRC), a numerical 11-point scale, which has shown good test-retest reliability (ICC = 0.9).
Time Frame
The gymnasts in the intervention group will answer the GRC on time when the intervention period has ended (June 2023)
Title
Self-experienced effect and progress related to UI
Description
Assessed by Global rating of change (GRC), a numerical 11-point scale, which has shown good test-retest reliability (ICC = 0.9).
Time Frame
The gymnasts in the intervention group will answer the GRC one time when the intervention period has ended (June 2023)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Rhythmic gymnastics is a female sport in Norway. Hence, the study will only include female gymnasts.
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Female rhythmic gymnasts <12 years of age training <3 days per week
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kari Bø, PhD
Phone
+4723262008
Email
karib@nih.no
First Name & Middle Initial & Last Name or Official Title & Degree
Marte C Dobbertin Gram, MSc
Phone
+4790971715
Email
mcgram@nih.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari Bø, PhD
Organizational Affiliation
Norwegian School of Sport Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Norwegian School of Sport Sciences
City
Oslo
ZIP/Postal Code
0863
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kari Bø, PhD
Phone
+4723262008
Email
karib@nih.no
First Name & Middle Initial & Last Name & Degree
Marte Gram, MSc
Phone
+4790971715
Email
mcgram@nih.no
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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32868315
Citation
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Prevention and Treatment of Injuries and Urinary Incontinence Among Norwegian Rhythmic Gymnasts
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