Knee Osteoarthritis (Knee OA)OsteoarthritisNCT06758388
Exercise-induced Irisin in Individuals With Knee Osteoarthritis.
A study testing home exercise program and home exercise program + brisk walking exercise in people with Knee Osteoarthritis (Knee OA), run by Ümmahani Kuş at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective randomised controled study is to investigate the effect of 8-weeks brisk walking exercise on irisin levels, physical and psychosocial parameters in individuals with knee osteoarthritis, and the relationship between irisin levels and physical and psychosocial parameters. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- home exercise program and home exercise program + brisk walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2025to 4 Aug 2025
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with idiopathic knee OA
- Stage 1-3 knee OA according to the Kellgren-Lawrence classification
- Patients aged 40-65
- Patients agreeing to participate in the study
- Patients having physical and cognitive ability to participate in the exercise program
Who cannot join
- History of depression and/or anxiety etc. psychiatric disease
- Uncontrolled hypertension, uncontrolled heart rhythm disorders, history of hospitalization for cardiovascular reasons in the last 6 months
- History of symptomatic pulmonary disease
- Use of medication due to dyslipidemia and/or diabetes
- Presence of acute inflammation or effusion in the knee joint
- Presence of central or peripheral neurological disease that will cause loss of lower extremity muscle strength, sensation, and balance
Show all 12Show fewer
- Presence of a prosthetic joint in the knee and previous lower extremity surgery
- Having received a physical therapy program in the last 6 months
- Patients with severe visual or hearing impairment
- Patients with severe peripheral vascular disorders
- Presence of severe knee joint instability, ligament and meniscal damage
- Being illiterate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman
About this study
Official title: The Relationship Between Physical and Psychosocial Status and Irisin Level in Individuals With Knee Osteoarthritis Performing Brisk Walking Exercise
The goal of this prospective randomised controled study is to investigate the effect of 8-weeks brisk walking exercise on irisin levels, physical and psychosocial parameters in individuals with knee osteoarthritis, and the relationship between irisin levels and physical and psychosocial parameters. The main question it aims to answer is: does 8-weeks brisk walking exercise increase irisin levels and imoroves physical and psychosocial parameters and is the irisin level in relation with the physical and psychosocial parameters.
Read the detailed description
Irisin is a myokine secreted by skeletal muscle after physical activity. It improves subchondral bone density and quality by increasing osteoblast differentiation and proliferation and improves the mechanical support of cartilage. In addition, irisin promotes chondrocyte proliferation, inhibits chondrocyte apoptosis, and reduces the secretion of inflammatory factors and matrix metalloproteinases. As a result of all these, improvements in joint function may be achieved.
Besides, irisin can improve depressive mood in patients with depression, and irisin level is found to be positively correlated with sleep quality and negatively correlated with disease duration and disease activity in patients with rheumatoid arthritis.
This study aims to investigate the effect of an 8-week moderate-intensity brisk walking exercise program on irisin serum levels and physical and psychosocial parameters in individuals with knee osteoarthritis and the relationship between irisin levels and physical and psychosocial parameters.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- home exercise program, home exercise program + brisk walking exercise
- Keywords
- Knee osteoarthritis, İrisin, FNDC5, Pain, Functional capacity, Depression, Fatigue, Sleep quality, Quality of life, Muscle strength
- Medical subject headings
- Osteoarthritis, Knee, Pain, Depression, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home exercise programOther
The prepared home exercise program is a program that includes gradual strengthening exercises that participants will do once a day, 5 days a week, for 8 weeks. The exercises will be performed as 1 set for the first 2 weeks, 2 sets in the 3rd and 4th weeks, and 3 sets in the last 4 weeks.
home exercise program + brisk walking exerciseBehavioural
In addition to the home exercise program applied by the control group, a brisk walk will be performed. The brisk walking exercise will be done for 30 minutes, 5 days a week for 8 weeks. The intensity of the exercise will be adjusted according to the Borg CR-10 scale and the Speech test. Moderate intensity exercise is recommended for participants. The participant will walk rhythmically for 30 minutes at a speed where he/she will give 4-6 points on the Borg CR-10 Scale, and can speak a few sentences without getting out of breath according to the Speech test, but cannot sing. Before and after the brisk walk, he/she will be asked to walk at a slow speed for 5 minutes (warm-up-cool down).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The control group will perform a home exercise program that includes progressive strengthening exercises. Receives: Other: home exercise program |
| Intervention group | Active comparator | The intervention group will perform a home exercise program that includes progressive strengthening exercises and brisk walking exercise. Receives: Behavioral: home exercise program + brisk walking exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The most commonly used measurement tool to assess pain is the Visual Analog Scale (VAS). Patients are asked to rate the intensity of their pain at rest and during activity. A score of 0 indicates no pain, while a score of 10 indicates unbearable pain.
Measured: 8 weeks
Range of Motion of the Joint
To measure the range of motion of knee flexion and extension, the pivot point of the goniometer is the lateral condyle of the femur while the patient is in the prone position. One of the arms of the goniometer is fixed parallel to the lateral midline of the femur. The movable arm follows the fibula. The degree that the patient can perform is recorded.
Measured: 8 weeks
Muscle Strength
Quadriceps muscle strength will be assessed with a hand-held dynamometer (Lafayette). The participant is in a sitting position with hips and knees flexed to 90°. The dynamometer is placed on the anterior surface of the leg just proximal to the ankle. During the measurement, the participant is asked to apply maximum pushing force against the device for 5 seconds. The measured force will be recorded in 'kg'.
Measured: 8 weeks
Functional Level
The six-minute walk test (6MWT) will be used to determine the functional level. The 6MWT is used to evaluate the person's endurance and ability to walk long distances. The person walks the maximum distance they can walk as fast as possible on a 30-meter flat track in 6 minutes. The distance the person walked is added up at the end of the test and the longer distance indicates better performance.
Measured: 8 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a self-report scale used to assess symptoms and functional status that may develop due to knee injuries and osteoarthritis. The scale, which questions the last week, has 5 subgroups: symptoms, pain, functional status related to daily living activities, functional status in sports and leisure activities, and quality of life related to the knee, and the scale consists of a total of 42 questions. Each subsection is scored between 0 and 100 points, with 0 points indicating a serious problem and 100 points indicating no problem.
Measured: 8 weeks
Assessment of quality of life
The Knee and Hip Osteoarthritis Quality of Life Scale (OAKHQOL) will be used to assess quality of life. The Knee and Hip Osteoarthritis Quality of Life Scale consists of 5 subsections: physical activity, mental health, pain, social functions and social support. The scale consists of 43 items. Each item in the scale is scored between 0 and 10, taking into account the last 4 weeks. 0 means 'not at all', 10 means 'very extreme, constant'. The calculation is made out of 100 according to the average score of the items in each subsection. As the total score increases, the quality of life increases.
Measured: 8 weeks
Depression
The presence of depression will be assessed with the Beck Depression Index-II (BDI-II). The BDI-II consists of 21 items. Participants are asked to give a score between 0 and 3 for each item, taking into account the last week. The severity of depression increases as the total score obtained from the scale increases. The main difference between the BDI-II and previous versions is that it includes items that aim to measure structures such as loss of energy, worthlessness, appetite disorders and concentration.
Measured: 8 weeks
Fatigue
The Fatigue Severity Scale will be used to assess fatigue. The Fatigue Severity Scale assesses fatigue in the last month. The scale consists of 9 items and the items are scored between 0 and 7. A score of 0 means I completely disagree, a score of 7 means I agree. The scale score is obtained by dividing the total score by the number of items. The higher the score, the higher the fatigue level.
Measured: 8 weeks
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. The scale, which assesses the person's sleep quality in the last month, begins with 4 open-ended questions and consists of a total of 24 questions. In the PSQI assessment, 18 questions answered by the person themselves are used in scoring. The PSQI has 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleeping pill use, and daytime dysfunction. Each question is answered on a scale of 0-3. The sum of the 7 component scores constitutes the total PSQI score. The total score of the scale is between 0 and 21 points. A total score of 5 or less indicates good sleep quality, while a score above 5 indicates poor sleep quality.
Measured: 8 weeks
İrisin level
Blood samples will be collected from the participants at the beginning of the study and after 8 weeks of exercise (1 day after the last exercise). Blood samples will be centrifuged at 3000 rpm at +4 0C for 10 minutes to separate plasma and samples will be collected in aliquots in Eppendorf tubes and stored at -80 0C until the day of the study. Serum irisin level will be determined using the human irisin Enzyme-Linked Immunosorbent Assay (ELISA) test kit.
Measured: 8 weeks
Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: 8 weeks
Secondary outcomes (1)
Correlation between irisin level (ng/mL) and primary outcome measures
Multivariate analyses will be carried out with control variables;
- Body mass index (Weight and height will be combined to report BMI in kg/m^2)
- Pain VAS score
- Quadriceps strength assessed with hand-held dynamometer (HHD) (Kg)
- Six-minute walk test (m)
- Knee Injury and Osteoarthritis Outcome Score
- The Knee and Hip Osteoarthritis Quality of Life Scale (OAKHQOL) Score
- Beck Depression Index-II (BDI-II) Score
- Fatigue Severity Scale Score
- Pittsburgh Sleep Quality Index (PSQI) Score
- Range of motion (degrees)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start13 Mar 2025
- Primary completion5 Jun 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ümmahani Kuş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ümmahani Kuş, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758388
- Sponsor's protocol ID
- E-11095095-050.04-225853
- Acronym
- Osteoarthritis
- Status last verified
- Aug 2025
- First submitted
- 12 Dec 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Physical and Psychosocial Status and Irisin Level in Individuals With Knee Osteoarthritis Performing Brisk Walking Exercise
- ClinicalTrials.gov ID
- NCT06758388
- Acronym / sponsor ID
- Osteoarthritis / E-11095095-050.04-225853
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Knee osteoarthritis, İrisin, FNDC5, Pain, Functional capacity, Depression, Fatigue, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ümmahani KuşUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 3 Jan 2025 (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 goal of this prospective randomised controled study is to investigate the effect of 8-weeks brisk walking exercise on irisin levels, physical and psychosocial parameters in individuals with knee osteoarthritis, and the relationship between irisin levels and physical and psychosocial parameters. The main question it aims to answer is: does 8-weeks brisk walking exercise increase irisin levels and imoroves physical and psychosocial parameters and is the irisin level in relation with the physical and psychosocial parameters.
Detailed description
Irisin is a myokine secreted by skeletal muscle after physical activity. It improves subchondral bone density and quality by increasing osteoblast differentiation and proliferation and improves the mechanical support of cartilage. In addition, irisin promotes chondrocyte proliferation, inhibits chondrocyte apoptosis, and reduces the secretion of inflammatory factors and matrix metalloproteinases. As a result of all these, improvements in joint function may be achieved.
Besides, irisin can improve depressive mood in patients with depression, and irisin level is found to be positively correlated with sleep quality and negatively correlated with disease duration and disease activity in patients with rheumatoid arthritis.
This study aims to investigate the effect of an 8-week moderate-intensity brisk walking exercise program on irisin serum levels and physical and psychosocial parameters in individuals with knee osteoarthritis and the relationship between irisin levels and physical and psychosocial parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: home exercise programThe control group will perform a home exercise program that includes progressive strengthening exercises. |
| Intervention group | Active comparator | Behavioral: home exercise program + brisk walking exerciseThe intervention group will perform a home exercise program that includes progressive strengthening exercises and brisk walking exercise. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with idiopathic knee OA
- Stage 1-3 knee OA according to the Kellgren-Lawrence classification
- Patients aged 40-65
- Patients agreeing to participate in the study
- Patients having physical and cognitive ability to participate in the exercise program
Key exclusion criteria (12 listed)
- History of depression and/or anxiety etc. psychiatric disease
- Uncontrolled hypertension, uncontrolled heart rhythm disorders, history of hospitalization for cardiovascular reasons in the last 6 months
- History of symptomatic pulmonary disease
- Use of medication due to dyslipidemia and/or diabetes
- Presence of acute inflammation or effusion in the knee joint
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 |
|---|---|---|
| home exercise programThe prepared home exercise program is a program that includes gradual strengthening exercises that participants will do once a day, 5 days a week, for 8 weeks. The exercises will be performed as 1 set for the first 2 weeks, 2 sets in the 3rd and 4th weeks, and 3 sets in the last 4 weeks. | Other | Control group |
| home exercise program + brisk walking exerciseIn addition to the home exercise program applied by the control group, a brisk walk will be performed. The brisk walking exercise will be done for 30 minutes, 5 days a week for 8 weeks. The intensity of the exercise will be adjusted according to the Borg CR-10 scale and the Speech test. Moderate intensity exercise is recommended for participants. The participant will walk rhythmically for 30 minutes at a speed where he/she will give 4-6 points on the Borg CR-10 Scale, and can speak a few sentences without getting out of breath according to the Speech test, but cannot sing. Before and after the brisk walk, he/she will be asked to walk at a slow speed for 5 minutes (warm-up-cool down). | Behavioural | Intervention group |
Primary outcome
Pain intensity
Time frame: 8 weeks
The most commonly used measurement tool to assess pain is the Visual Analog Scale (VAS). Patients are asked to rate the intensity of their pain at rest and during activity. A score of 0 indicates no pain, while a score of 10 indicates unbearable pain.
Range of Motion of the Joint
Time frame: 8 weeks
To measure the range of motion of knee flexion and extension, the pivot point of the goniometer is the lateral condyle of the femur while the patient is in the prone position. One of the arms of the goniometer is fixed parallel to the lateral midline of the femur. The movable arm follows the fibula. The degree that the patient can perform is recorded.
Muscle Strength
Time frame: 8 weeks
Quadriceps muscle strength will be assessed with a hand-held dynamometer (Lafayette). The participant is in a sitting position with hips and knees flexed to 90°. The dynamometer is placed on the anterior surface of the leg just proximal to the ankle. During the measurement, the participant is asked to apply maximum pushing force against the device for 5 seconds. The measured force will be recorded in 'kg'.
Functional Level
Time frame: 8 weeks
The six-minute walk test (6MWT) will be used to determine the functional level. The 6MWT is used to evaluate the person's endurance and ability to walk long distances. The person walks the maximum distance they can walk as fast as possible on a 30-meter flat track in 6 minutes. The distance the person walked is added up at the end of the test and the longer distance indicates better performance.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 8 weeks
KOOS is a self-report scale used to assess symptoms and functional status that may develop due to knee injuries and osteoarthritis. The scale, which questions the last week, has 5 subgroups: symptoms, pain, functional status related to daily living activities, functional status in sports and leisure activities, and quality of life related to the knee, and the scale consists of a total of 42 questions. Each subsection is scored between 0 and 100 points, with 0 points indicating a serious problem and 100 points indicating no problem.
Assessment of quality of life
Time frame: 8 weeks
The Knee and Hip Osteoarthritis Quality of Life Scale (OAKHQOL) will be used to assess quality of life. The Knee and Hip Osteoarthritis Quality of Life Scale consists of 5 subsections: physical activity, mental health, pain, social functions and social support. The scale consists of 43 items. Each item in the scale is scored between 0 and 10, taking into account the last 4 weeks. 0 means 'not at all', 10 means 'very extreme, constant'. The calculation is made out of 100 according to the average score of the items in each subsection. As the total score increases, the quality of life increases.
Depression
Time frame: 8 weeks
The presence of depression will be assessed with the Beck Depression Index-II (BDI-II). The BDI-II consists of 21 items. Participants are asked to give a score between 0 and 3 for each item, taking into account the last week. The severity of depression increases as the total score obtained from the scale increases. The main difference between the BDI-II and previous versions is that it includes items that aim to measure structures such as loss of energy, worthlessness, appetite disorders and concentration.
Fatigue
Time frame: 8 weeks
The Fatigue Severity Scale will be used to assess fatigue. The Fatigue Severity Scale assesses fatigue in the last month. The scale consists of 9 items and the items are scored between 0 and 7. A score of 0 means I completely disagree, a score of 7 means I agree. The scale score is obtained by dividing the total score by the number of items. The higher the score, the higher the fatigue level.
Sleep Quality
Time frame: 8 weeks
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. The scale, which assesses the person's sleep quality in the last month, begins with 4 open-ended questions and consists of a total of 24 questions. In the PSQI assessment, 18 questions answered by the person themselves are used in scoring. The PSQI has 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleeping pill use, and daytime dysfunction. Each question is answered on a scale of 0-3. The sum of the 7 component scores constitutes the total PSQI score. The total score of the scale is between 0 and 21 points. A total score of 5 or less indicates good sleep quality, while a score above 5 indicates poor sleep quality.
İrisin level
Time frame: 8 weeks
Blood samples will be collected from the participants at the beginning of the study and after 8 weeks of exercise (1 day after the last exercise). Blood samples will be centrifuged at 3000 rpm at +4 0C for 10 minutes to separate plasma and samples will be collected in aliquots in Eppendorf tubes and stored at -80 0C until the day of the study. Serum irisin level will be determined using the human irisin Enzyme-Linked Immunosorbent Assay (ELISA) test kit.
Body mass index
Time frame: 8 weeks
Weight and height will be combined to report BMI in kg/m^2
1 secondary outcome
Correlation between irisin level (ng/mL) and primary outcome measures
Time frame: 8 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 5 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home exercise program and home exercise program + brisk walking exercise in people with Knee Osteoarthritis (Knee OA), run by Ümmahani Kuş 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 5 inclusion and 12 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 2025. 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?
Pain intensity (time frame: 8 weeks). The study lists 11 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 5 Aug 2025.