- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05054686
Effects of Concurrent Exercise Combinations in Knee Osteoarthritis:
Effects of Concurrent Exercise Combinations on Pain, Function, and Proprioception in Knee Osteoarthritis: A Prospective Randomized Controlled Parallel Group Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alkent 2000, Büyükçekmece/İstanbul
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Küçükçekmece, Alkent 2000, Büyükçekmece/İstanbul, Turkey (Türkiye), 34307
- Seda Baktır
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being diagnosed as knee osteoarthritis
- Being between the ages 45-74
- Being at stage 2-3 according to Kellegren Lawrence Classification
- Having body mass index lower than 30
- Being volunteer for participation to this study
Exclusion Criteria:
- Refusing to participation to study
- Having another orthopeadic problem ralated to lower extremity
- Having uncontrollable hypertension
- Having arterial and venous disease
- Having neurological disease
- Having perceptual problem
- Having cardiac pacemaker
- Participation to physiotherapy program in the last 6 months for the same extremity
- Taking injection from the same extremity in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combination of Stretching and Aerobic Exercises at Clinic
Combination of Stretching and Aerobic Exercises at Clinic and Strengthening and Aerobic Exercises at Home
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In this group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.
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Active Comparator: Combination of Strengthening and Aerobic Exercises at Clinic
Combination of Strengthening and Aerobic Exercises at Clinic and Stretching and Aerobic Exercises at Home
|
In this group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program.
|
|
Active Comparator: Combination of Strengthening, Stretching and Aerobic Exercises at Clinic
Combination of Strengthening, Stretching and Aerobic Exercises at Clinic and Aerobic Exercises at Home
|
In this group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Western Ontario and McMaster Universities Arthritis Index
Time Frame: Change of The Western Ontario and McMaster Universities Arthritis Index scores from the beginning to the end of study (8 weeks)
|
The Western Ontario and McMaster Universities Arthritis Index is a questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The increasing scores reflect improvement of the function. |
Change of The Western Ontario and McMaster Universities Arthritis Index scores from the beginning to the end of study (8 weeks)
|
|
Numeric Pain Rating Scale
Time Frame: Change of Numeric Pain Rating Scale scores from the beginning to the end of study (8 weeks)
|
The Numeric Pain Rating Scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 likert type integers) that best reflects the intensity of his/her pain.The levels of pain felt at rest / activity / night will be evaluated.
The increase in pain scores demonstrate that the health status get worse.
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Change of Numeric Pain Rating Scale scores from the beginning to the end of study (8 weeks)
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Pain Pressure Treshold (PPT)
Time Frame: Change of Pain Pressure Treshold measurements from the beginning to the end of study (8 weeks)
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Pain Pressure Treshold is evaluated via algometric measurement that were taken from 4 point including the mid portion of patella, 3 cm medial to patellar midline, 3 cm lateral to patellar midline, 2 cm above to patellar upper boundary.The increase in algometric measurement demonstrate the development in the pain sensitivity.
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Change of Pain Pressure Treshold measurements from the beginning to the end of study (8 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proprioception
Time Frame: Change of Inclinometric measurements from the beginning to the end of study (8 weeks).
|
Proprioception will be evaluated with digital inclinometer from 90 degree knee flexion to 30 degree knee flexion angle.
The deviation from this interval reflects that the detoriation of knee joint proprioception.
Therefore, decreasing deviation scores obtained from the inclinometer reflects better proprioceptive sensation.
|
Change of Inclinometric measurements from the beginning to the end of study (8 weeks).
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Knee Muscle Strength
Time Frame: Change of muscle strength measurements from the beginning to the end of study (8 weeks)
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Muscle strength for knee flexor and extensor muscles Knee joint muscle strength was measured by using hand-held dinamometer.
The measurements had taken for quadrieps and hamstring muscles.
the incresing muscle strength values reflects improvement of strength of muscles around knee joint.
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Change of muscle strength measurements from the beginning to the end of study (8 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seda BAKTIR, MSc.PT., Istanbul University - Cerrahpasa
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
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Pain
- Osteoarthritis, Knee
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- IstanbulUCSEDA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Knee Osteoarthritis
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Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
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Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
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