Back to resultsThe Effect of Bike Exercise on Joint and Muscles
Primary Purpose
Knee Osteoarthritis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Recumbent Bike
Upright Bike
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Joint, Exercise, Ultrasound, Bicycle
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Mersin University Department of Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Controls 1
Healthy Controls 2
Arm Description
Healthy individuals participating in the study will be divided into two groups.
Healthy individuals participating in the study will be divided into two groups.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05564364
Brief Title
The Effect of Bike Exercise on Joint and Muscles
Official Title
The Effect of Two Different Bikes Exercises on Healthy Knee Joint Cartilage and Lower
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Joint, Exercise, Ultrasound, Bicycle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Controls 1
Arm Type
Experimental
Arm Description
Healthy individuals participating in the study will be divided into two groups.
Arm Title
Healthy Controls 2
Arm Type
Experimental
Arm Description
Healthy individuals participating in the study will be divided into two groups.
Intervention Type
Device
Intervention Name(s)
Recumbent Bike
Intervention Description
The first group will exercise with a recumbent bike for 20 minutes, 3 sessions/week for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Upright Bike
Intervention Description
The first group will exercise with a upright bike for 20 minutes, 3 sessions/week for 6 weeks.
Primary Outcome Measure Information:
Title
Baseline knee joint cartilage thickness and muscles thicknesses
Description
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.
Time Frame
Just before first exercises session
Title
Knee cartilage thickness and muscles thicknesses after 6 weeks training program
Description
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.
Time Frame
After 6 weeks training program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orhan Güvener, MD
Organizational Affiliation
Mersin University Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Figen Dağ, PhD
Organizational Affiliation
Mersin University Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Mersin University Department of Physical Medicine and Rehabilitation
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of Bike Exercise on Joint and Muscles
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