- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04972305
The Impact of the Prevention Program Developed for Injuries in Recreational Cyclists
The Effect of the Prevention Program Developed for Injuries in Recreational Cyclists on Physical Performance and Physical Fitness Parameters
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Considering the pandemic period we are living in, people are much more interested in health, sports and nature than they used to be. From this perspective, the interest in cycling, which can accommodate all of these features at the same time, is rapidly increasing. Individuals take bicycle rides in nature in their free time and make this activity a way of life. However, as in every physical activity, factors such as lack of knowledge in cycling, choosing the wrong bike and material, and not knowing the important basics of sports cause non-traumatic injuries in cyclists.
While transitioning from the sedentary life brought by the age of technology to the activity, the musculoskeletal systems of individuals are caught unprepared and even exposed to various traumas and biomechanical problems. Because the looping motion of the lower extremities while cycling occurs primarily in the sagittal plane, power imbalances can develop that affect a cyclist's susceptibility to injury elsewhere along the kinetic chain. The most common areas of overuse injury in cycling are the knee, lumbar spine, cervical spine, hip, Achilles tendon, wrists, and forearm.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey, 27090
- Yusuf Şinasi Kirmaci
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Recreational cycling for at least 1 year
- body mass index between 18.5-25 kg / m²
- Obtaining a written health report stating "there is no harm in using a bicycle"
Exclusion Criteria:
- History of fracture, trauma or surgery in the last 6 months
- have any systemic or neurological problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise group
12 weeks exercise programme, 3 days a week Bicycle ergonomics will be applied.
|
12 week exercise and fit bike
|
Experimental: Ergonomics group
Bicycle ergonomics will be applied.
|
Fit bike
|
No Intervention: Control group
No Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Composition
Time Frame: Change from Baseline at 12th weeks and 6th month
|
Body fat percentage will be determined by skinfold measurement
|
Change from Baseline at 12th weeks and 6th month
|
Muscle strength
Time Frame: Change from Baseline at 12th weeks and 6th month
|
It will be measured with "1 max rep" (1RM).
|
Change from Baseline at 12th weeks and 6th month
|
Flexibility
Time Frame: Change from Baseline at 12th weeks and 6th month
|
It will be evaluated with sit-reach test and modified ober test.
|
Change from Baseline at 12th weeks and 6th month
|
Aerobic Capacity
Time Frame: Change from Baseline at 12th weeks and 6th month
|
It will be evaluated by shuttle run.
|
Change from Baseline at 12th weeks and 6th month
|
Functional threshold power test (FTP)
Time Frame: Change from Baseline at 12th weeks and 6th month
|
It is obtained by calculating the force applied while pedaling for 20 minutes.
|
Change from Baseline at 12th weeks and 6th month
|
Lactate threshold heart rate
Time Frame: Change from Baseline at 12th weeks and 6th month
|
Average heart rate taken while pedaling for 20 minutes.
|
Change from Baseline at 12th weeks and 6th month
|
10-Mile Trial Test
Time Frame: Change from Baseline at 12th weeks and 6th month
|
The time it takes to complete 10 miles in the fastest possible time is counted.
|
Change from Baseline at 12th weeks and 6th month
|
Critical Power test
Time Frame: Change from Baseline at 12th weeks and 6th month
|
It is the estimation of the maximum effort that can be sustained for 3 minutes.
|
Change from Baseline at 12th weeks and 6th month
|
Muscle myotonometric properties
Time Frame: Change from Baseline at 12th weeks and 6th month
|
It will be measured with myoton pro.
|
Change from Baseline at 12th weeks and 6th month
|
Balance
Time Frame: Change from Baseline at 12th weeks and 6th month
|
It will be measured with Y balance test.
|
Change from Baseline at 12th weeks and 6th month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived pain
Time Frame: Change from Baseline at 12th weeks and 6th month
|
It will be measured with McGill pain questionnaire
|
Change from Baseline at 12th weeks and 6th month
|
İnjury
Time Frame: Change from Baseline at 12th weeks and 6th month
|
It will be measured with The Nordic musculoskeletal questionnaire
|
Change from Baseline at 12th weeks and 6th month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: GÜNSELİ USGU, Hasan Kalyoncu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- YusufK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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