Knee OsteoarthritisNCT05564364
The Effect of Bike Exercise on Joint and Muscles
A study testing Recumbent Bike and Upright Bike in people with Knee Osteoarthritis, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The design of our study is a prospective. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the effects of two different bike exercises on knee joint and lower extremity muscles by ultrasonographic method. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Recumbent Bike and Upright Bike
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Nov 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-35
- Not exercising regularly
- BMI between 18.9-24.9 kg/m2
- Volunteering to participate in the study
- Absence of chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program.
- Those who do not have a history of pregnancy, malignant hematological and oncological diseases
Show all 9Show fewer
- Not smoking
- No musculoskeletal problems of the lower extremity in the last 6 months
- No previous history of lower extremity surgery in the last 1 year
Who cannot join
- Being outside the age range of 18-35
- Exercising regularly
- Being outside of the BMI 18.9-24.9 kg/m2 range
- Having chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program
- Those with a history of pregnancy, malignant hematological and oncological diseases
- Individuals who smoke
- Any musculoskeletal problem of the lower extremity in the last 6 months
- Having a history of lower extremity surgery in the last 1 year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Department of Physical Medicine and Rehabilitation
Mersin, 33110
About this study
Official title: The Effect of Two Different Bikes Exercises on Healthy Knee Joint Cartilage and Lower
The design of our study is a prospective. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the effects of two different bike exercises on knee joint and lower extremity muscles by ultrasonographic method.
- Conditions
- Knee Osteoarthritis
- Being tested
- Recumbent Bike, Upright Bike
- Keywords
- Knee Joint, Exercise, Ultrasound, Bicycle
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recumbent BikeDevice
The first group will exercise with a recumbent bike for 20 minutes, 3 sessions/week for 6 weeks.
Upright BikeDevice
The first group will exercise with a upright bike for 20 minutes, 3 sessions/week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls 1 | Experimental | Healthy individuals participating in the study will be divided into two groups. Receives: Device: Recumbent Bike |
| Healthy Controls 2 | Experimental | Healthy individuals participating in the study will be divided into two groups. Receives: Device: Upright Bike |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline knee joint cartilage thickness and muscles thicknesses
Ultrasonographic measurements will be made using linear probes (5-13 megahertz Logiq P5; GE Medical Systems) .Joint cartillage thickness and lower extremity muscles will measured by ultrasound at baseline.
Measured: Just before first exercises session
Knee cartilage thickness and muscles thicknesses after 6 weeks training program
Ultrasonographic measurements will be made using linear probes (5-13 megahertz Logiq P5; GE Medical Systems) .Joint cartillage and lower extremity muscles will measured by ultrasound after 6 weeks training program. Joint cartillage thickness and lower extremity muscles will measured by ultrasound after 6 weeks.
Measured: After 6 weeks training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start15 Nov 2022
- Primary completion15 Sep 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orhan Güvener, Mersin University
- Investigators
- Orhan Güvener, MD, Principal investigator, Mersin University Medical SchoolFigen Dağ, PhD, Study chair, Mersin University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564364
- Sponsor's protocol ID
- MEUTF-FTR-GUVENER-002
- Status last verified
- Feb 2024
- First submitted
- 22 Sep 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Bikes Exercises on Healthy Knee Joint Cartilage and Lower
- ClinicalTrials.gov ID
- NCT05564364
- Acronym / sponsor ID
- MEUTF-FTR-GUVENER-002
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Joint, Exercise, Ultrasound, Bicycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 3 Oct 2022 (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 design of our study is a prospective. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the effects of two different bike exercises on knee joint and lower extremity muscles by ultrasonographic method.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls 1 | Experimental | Device: Recumbent BikeHealthy individuals participating in the study will be divided into two groups. |
| Healthy Controls 2 | Experimental | Device: Upright BikeHealthy individuals participating in the study will be divided into two groups. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Being between the ages of 18-35
- Not exercising regularly
- BMI between 18.9-24.9 kg/m2
- Volunteering to participate in the study
- Absence of chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program.
Key exclusion criteria (8 listed)
- Being outside the age range of 18-35
- Exercising regularly
- Being outside of the BMI 18.9-24.9 kg/m2 range
- Having chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program
- Those with a history of pregnancy, malignant hematological and oncological diseases
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 |
|---|---|---|
| Recumbent BikeThe first group will exercise with a recumbent bike for 20 minutes, 3 sessions/week for 6 weeks. | Device | Healthy Controls 1 |
| Upright BikeThe first group will exercise with a upright bike for 20 minutes, 3 sessions/week for 6 weeks. | Device | Healthy Controls 2 |
Primary outcome
Baseline knee joint cartilage thickness and muscles thicknesses
Time frame: Just before first exercises session
Ultrasonographic measurements will be made using linear probes (5-13 megahertz Logiq P5; GE Medical Systems) .Joint cartillage thickness and lower extremity muscles will measured by ultrasound at baseline.
Knee cartilage thickness and muscles thicknesses after 6 weeks training program
Time frame: After 6 weeks training program
Ultrasonographic measurements will be made using linear probes (5-13 megahertz Logiq P5; GE Medical Systems) .Joint cartillage and lower extremity muscles will measured by ultrasound after 6 weeks training program. Joint cartillage thickness and lower extremity muscles will measured by ultrasound after 6 weeks.
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 7 Feb 2024.
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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.
Orhan Güvener, MD principal investigator
Mersin University Medical School
Figen Dağ, PhD study chair
Mersin University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recumbent Bike and Upright Bike in people with Knee Osteoarthritis, run by Mersin 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 9 inclusion and 8 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 7 Feb 2024. 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?
Baseline knee joint cartilage thickness and muscles thicknesses (time frame: Just before first exercises session). 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?
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 7 Feb 2024.