Sports Physical TherapyNCT04972305
The Impact of the Prevention Program Developed for Injuries in Recreational Cyclists
A study testing Exercise and ergonomics and Ergonomics in people with Sports Physical Therapy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effects of personal ergonomic adaptations of the bicycle on the bicycle performance parameters, together with the exercise program training created to prevent biomechanical problems that cause injuries in recreational cyclist. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Exercise and ergonomics and Ergonomics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 30 May 2022
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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"
Who cannot join
- History of fracture, trauma or surgery in the last 6 months
- have any systemic or neurological problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Prevention Program Developed for Injuries in Recreational Cyclists on Physical Performance and Physical Fitness Parameters
The aim of this study is to determine the effects of personal ergonomic adaptations of the bicycle on the bicycle performance parameters, together with the exercise program training created to prevent biomechanical problems that cause injuries in recreational cyclist.
Read the 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.
- Conditions
- Sports Physical Therapy
- Being tested
- Exercise and ergonomics, Ergonomics
- Keywords
- recreational cyclist, exercise, physical fitness, sports performance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and ergonomicsOther
12 week exercise and fit bike
ErgonomicsOther
Fit bike
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 12 weeks exercise programme, 3 days a week Bicycle ergonomics will be applied. Receives: Other: Exercise and ergonomics |
| Ergonomics group | Experimental | Bicycle ergonomics will be applied. Receives: Other: Ergonomics |
| Control group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Body fat percentage will be determined by skinfold measurement
Measured: Change from Baseline at 12th weeks and 6th month
Muscle strength
It will be measured with "1 max rep" (1RM).
Measured: Change from Baseline at 12th weeks and 6th month
Flexibility
It will be evaluated with sit-reach test and modified ober test.
Measured: Change from Baseline at 12th weeks and 6th month
Aerobic Capacity
It will be evaluated by shuttle run.
Measured: Change from Baseline at 12th weeks and 6th month
Functional threshold power test (FTP)
It is obtained by calculating the force applied while pedaling for 20 minutes.
Measured: Change from Baseline at 12th weeks and 6th month
Lactate threshold heart rate
Average heart rate taken while pedaling for 20 minutes.
Measured: Change from Baseline at 12th weeks and 6th month
10-Mile Trial Test
The time it takes to complete 10 miles in the fastest possible time is counted.
Measured: Change from Baseline at 12th weeks and 6th month
Critical Power test
It is the estimation of the maximum effort that can be sustained for 3 minutes.
Measured: Change from Baseline at 12th weeks and 6th month
Muscle myotonometric properties
It will be measured with myoton pro.
Measured: Change from Baseline at 12th weeks and 6th month
Balance
It will be measured with Y balance test.
Measured: Change from Baseline at 12th weeks and 6th month
Secondary outcomes (2)
Perceived pain
It will be measured with McGill pain questionnaire
Measured: Change from Baseline at 12th weeks and 6th month
İnjury
It will be measured with The Nordic musculoskeletal questionnaire
Measured: Change from Baseline at 12th weeks and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Aug 2021
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUSUF ŞİNASİ KIRMACI, Hasan Kalyoncu University
- Investigators
- GÜNSELİ USGU, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972305
- Sponsor's protocol ID
- YusufK
- Status last verified
- Aug 2022
- First submitted
- 15 Jul 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirmaci YS, Usgu G. Effects of combined exercise training and bicycle ergonomic adaptation on cycling performance and physical fitness in recreational cyclists: a randomized controlled trial with 6-month follow-up. BMC Sports Sci Med Rehabil. 2026 Sep 12;18(1):526. doi: 10.1186/s13102-026-02081-1.
PubMed 42947243
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Prevention Program Developed for Injuries in Recreational Cyclists on Physical Performance and Physical Fitness Parameters
- ClinicalTrials.gov ID
- NCT04972305
- Acronym / sponsor ID
- YusufK
- Conditions
- Sports Physical Therapy
- Keywords
- recreational cyclist, exercise, physical fitness, sports performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effects of personal ergonomic adaptations of the bicycle on the bicycle performance parameters, together with the exercise program training created to prevent biomechanical problems that cause injuries in recreational cyclist.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise and ergonomics12 weeks exercise programme, 3 days a week Bicycle ergonomics will be applied. |
| Ergonomics group | Experimental | Other: ErgonomicsBicycle ergonomics will be applied. |
| Control group | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (2 listed)
- History of fracture, trauma or surgery in the last 6 months
- have any systemic or neurological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and ergonomics12 week exercise and fit bike | Other | Exercise group |
| ErgonomicsFit bike | Other | Ergonomics group |
Primary outcome
Body Composition
Time frame: Change from Baseline at 12th weeks and 6th month
Body fat percentage will be determined by skinfold measurement
Muscle strength
Time frame: Change from Baseline at 12th weeks and 6th month
It will be measured with "1 max rep" (1RM).
Flexibility
Time frame: Change from Baseline at 12th weeks and 6th month
It will be evaluated with sit-reach test and modified ober test.
Aerobic Capacity
Time frame: Change from Baseline at 12th weeks and 6th month
It will be evaluated by shuttle run.
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.
Lactate threshold heart rate
Time frame: Change from Baseline at 12th weeks and 6th month
Average heart rate taken while pedaling for 20 minutes.
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.
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.
Muscle myotonometric properties
Time frame: Change from Baseline at 12th weeks and 6th month
It will be measured with myoton pro.
Balance
Time frame: Change from Baseline at 12th weeks and 6th month
It will be measured with Y balance test.
2 secondary outcomes
Perceived pain
Time frame: Change from Baseline at 12th weeks and 6th month
İnjury
Time frame: Change from Baseline at 12th weeks and 6th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 42947243Kirmaci YS, Usgu G. Effects of combined exercise training and bicycle ergonomic adaptation on cycling performance and physical fitness in recreational cyclists: a randomized controlled trial with 6-month follow-up. BMC Sports Sci Med Rehabil. 2026 Sep 12;18(1):526. doi: 10.1186/s13102-026-02081-1.
- Individual participant dataSharing planned: No
Related trials for Sports Physical Therapy
Recruiting
Effects of Scapular Training on Adolescent Boxers
Sports Physical Therapy
Recruiting
Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Recruiting
French Contrast Versus Oregon Circuit Training in Competitive Football Players
No Disease or Condition is Being Studied
Recruiting
Diaphragmatic Facilitation and Upper Extremity Performance in Volleyball Players
Volleyball Players
Recruiting
Comparative Effects of Dolphin Kick Streamline Training Versus Flutter Kick Training in Competitive Swimmers
Sports Physical Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GÜNSELİ USGU study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and ergonomics and Ergonomics in people with Sports Physical Therapy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 5 Aug 2022. 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 Turkey (Türkiye). 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?
Body Composition (time frame: Change from Baseline at 12th weeks and 6th month). The study lists 10 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 NCT04972305, which also lists 1 linked publication.
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 5 Aug 2022.