Osteoarthritis (Knee)NCT07890155
Effect of Resistance Exercises on Serum IGF-1 Levels in Knee Osteoarthritis
A study testing Resistance Exercise Program in people with Osteoarthritis (Knee) and Metabolic Syndrome (MetS), run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effects of a resistance exercise program on serum Insulin-like Growth Factor 1 (IGF-1) levels in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis (Knee), Metabolic Syndrome (MetS)
- What is being tested?
- Resistance Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of knee osteoarthritis according to the American College of Rheumatology (ACR) clinical and radiographic criteria.
- Radiological severity of Kellgren-Lawrence (KL) grade 2 or 3 on standing anteroposterior knee radiographs
- Having a knee magnetic resonance imaging (MRI) scan obtained within the past 1 year
- Age between 40 and 75 years
- Volunteering to participate in the study and signing the informed consent form
Who cannot join
- Receiving intra-articular injections (e.g., corticosteroids, hyaluronic acid, PRP) in the affected knee within the last 6 months
- History of previous major knee surgery, knee arthroplasty, or lower extremity trauma affecting biomechanics
- Diagnosis of rheumatoid arthritis, or other inflammatory joint diseases
- Presence of severe cardiovascular, neurological, or musculoskeletal disorders that would contraindicate or prevent participation in a structured resistance exercise program
- History of malignancy or presence of active malignancy
- Presence of active infection
- Cognitive impairment or inability to understand and follow the exercise instructions and questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Istanbul, 34396
Bora Şahin, MD, PMR Resident Physician, +905386673139, borashn55@gmail.com
About this study
Official title: Changes in Serum IGF-1 Levels With Resistance Exercises in Patients With Knee Osteoarthritis and Their Association With Clinical and Radiological Parameters
The goal of this clinical trial is to evaluate the effects of a resistance exercise program on serum Insulin-like Growth Factor 1 (IGF-1) levels in patients with knee osteoarthritis. Specifically, it aims to investigate the relationship between changes in serum IGF-1 levels and clinical improvement after exercise therapy, and to evaluate the impact of the presence of osteoarthritis metabolic phenotype on this relationship.
Participants will be asked to complete a structured resistance exercise program for 8 weeks.
Researchers will compare the pre-exercise and post-exercise serum IGF-1 levels, clinical scores (WOMAC, VAS) and radiological findings (MOAKS Osteophyte Score) to determine the effectiveness of the intervention.
Read the detailed description
Knee osteoarthritis (OA) is a prevalent degenerative joint disease characterized by pain, functional impairment, and cartilage degradation. Resistance exercises are recommended as a core non-pharmacological treatment for knee OA, yet the exact biochemical mechanisms underlying its clinical benefits remain partially understood. Insulin-like Growth Factor 1 (IGF-1) is a critical anabolic biomarker involved in cartilage matrix synthesis and repair. Furthermore, recent studies suggest that knee OA is a heterogeneous disease, and the "metabolic phenotype" (often associated with obesity, dyslipidemia, insulin resistance, or hypertension) may significantly influence systemic inflammation, disease progression, and the patient's response to physical rehabilitation.
This study is designed to measure the changes in serum IGF-1 levels in patients with knee OA following a structured resistance exercise program, investigate the correlation between changes in serum IGF-1 and clinical improvements as well as radiological severity and evaluate the modifying effect of the metabolic phenotype on the relationship between biomarker changes and clinical outcomes.
This is a prospective, single-center, non-randomized clinical trial. Patients diagnosed with knee OA according to the American College of Rheumatology (ACR) criteria, specifically with a radiological severity of Kellgren-Lawrence grade 2 or 3, will be included in the study. Participants will be non-randomly allocated into two predefined groups at baseline:
- Metabolic phenotype group: Patients presenting with a metabolic phenotype. (The metabolic phenotype is defined as the presence of metabolic syndrome, using the 2009 Joint Interim Statement criteria. A clinical diagnosis requires the presence of at least three of the following five criteria:
- Elevated waist circumference (≥ 100 cm in men, ≥ 90 cm in women, based on the 2024 Guidelines of the Society of Endocrinology and Metabolism of Turkey)
- Elevated blood pressure (Systolic ≥ 130 mmHg and/or Diastolic ≥ 85 mmHg) or receiving treatment for hypertension
- Elevated fasting blood glucose (≥ 100 mg/dL) or previously diagnosed with diabetes mellitus.
- Elevated triglycerides (≥ 150 mg/dL) or receiving treatment for hypertriglyceridemia.
- Reduced HDL cholesterol (< 40 mg/dL in men, < 50 mg/dL in women) or receiving treatment for hyperlipidemia.)
- Non-Metabolic Phenotype group: Patients without a metabolic phenotype.
Both groups will receive the exact same intervention. All participants will undergo a supervised resistance exercise program targeting the lower extremities. The program will consist of for a total duration of 8 weeks.
Fasting venous blood samples will be drawn at baseline and post-intervention (at 8 weeks) to measure serum IGF-1 levels. Clinical status will be assessed using standard questionnaires including The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) for pain. Additionally, quadriceps muscle strength will be evaluated using a hand-held dynamometer at baseline and post-intervention. For radiological evaluation, baseline osteophyte scores will be assessed for all patients using the Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) system, based on MRI scans obtained within the past year.
- Conditions
- Osteoarthritis (Knee), Metabolic Syndrome (MetS)
- Being tested
- Resistance Exercise Program
- Keywords
- knee osteoarthritis, metabolic syndrome, metabolic phenotype, resistance exercise, insulin-like growth factor 1, IGF-1
- Medical subject headings
- Osteoarthritis, Knee, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise ProgramBehavioural
A supervised resistance exercise program targeting the lower extremity muscles (including quadriceps). The exercise protocol is applied for a total duration of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Phenotype Group | Experimental | Patients with knee osteoarthritis who meet the criteria for metabolic syndrome (metabolic phenotype). This group will undergo an 8-week supervised resistance exercise program. Receives: Behavioral: Resistance Exercise Program |
| Non-Metabolic Phenotype Group | Experimental | Patients with knee osteoarthritis who do not meet the criteria for metabolic syndrome. This group will also undergo the exact same 8-week supervised resistance exercise program. Receives: Behavioral: Resistance Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Insulin-like Growth Factor 1 (IGF-1) Levels
Serum IGF-1 levels will be measured from fasting venous blood samples to evaluate the systemic anabolic response to the resistance exercise program.
Measured: Baseline and at 8 weeks
Secondary outcomes (2)
Quadriceps Muscle Strength
Quadriceps muscle strength will be evaluated using a hand-held dynamometer. Higher values indicate greater muscle strength and better physical performance
Measured: Baseline and at 8 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
The WOMAC index is used to evaluate pain, stiffness, and physical function in patients with knee osteoarthritis. The total score ranges from 0 to 96, where higher scores indicate worse pain, stiffness, and more severe functional limitations. A decrease in the score indicates clinical improvement.
Measured: Baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (Knee)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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes a non-randomized, parallel assignment model. Participants diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) are allocated into two parallel groups at baseline based on their metabolic status, rather than through randomization. Group 1 consists of patients presenting with a metabolic phenotype (defined as meeting the 2009 Joint Interim Statement criteria for metabolic syndrome). Group 2 consists of patients without this metabolic phenotype. Both parallel groups will concurrently receive the exact same intervention: an 8-week supervised resistance exercise program targeting the lower extremities. This non-randomized parallel model allows researchers to directly compare the pre- and post-intervention changes in serum IGF-1 levels, quadriceps muscle strength, and clinical scores between the two distinct phenotypes. The goal is to determine if the baseline metabolic status influences the biochemical and clinical efficacy of the exercise therapy.
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora ŞAHİN, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Kadriye Banu Kuran, MD, Prof., Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890155
- Sponsor's protocol ID
- Sislietfal-PMR-OA-IGF-2026
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the fact that there is no plan or ethical approval to share identified participant data with researchers other than team.
Publications
Escribano-Nunez A, Cornelis FMF, De Roover A, Sermon A, Cailotto F, Lories RJ, Monteagudo S. IGF1 drives Wnt-induced joint damage and is a potential therapeutic target for osteoarthritis. Nat Commun. 2024 Oct 24;15(1):9170. doi: 10.1038/s41467-024-53604-8.
PubMed 39448593Jansen NEJ, Molendijk E, Schiphof D, van Meurs JBJ, Oei EHG, van Middelkoop M, Bierma-Zeinstra SMA. Metabolic syndrome and the progression of knee osteoarthritis on MRI. Osteoarthritis Cartilage. 2023 May;31(5):647-655. doi: 10.1016/j.joca.2023.02.003. Epub 2023 Feb 16.
PubMed 36801367Deveza LA, Melo L, Yamato TP, Mills K, Ravi V, Hunter DJ. Knee osteoarthritis phenotypes and their relevance for outcomes: a systematic review. Osteoarthritis Cartilage. 2017 Dec;25(12):1926-1941. doi: 10.1016/j.joca.2017.08.009. Epub 2017 Aug 25.
PubMed 28847624
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Serum IGF-1 Levels With Resistance Exercises in Patients With Knee Osteoarthritis and Their Association With Clinical and Radiological Parameters
- ClinicalTrials.gov ID
- NCT07890155
- Acronym / sponsor ID
- Sislietfal-PMR-OA-IGF-2026
- Conditions
- Osteoarthritis (Knee), Metabolic Syndrome (MetS)
- Keywords
- knee osteoarthritis, metabolic syndrome, metabolic phenotype, resistance exercise, insulin-like growth factor 1, IGF-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Oct 2026 (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 clinical trial is to evaluate the effects of a resistance exercise program on serum Insulin-like Growth Factor 1 (IGF-1) levels in patients with knee osteoarthritis. Specifically, it aims to investigate the relationship between changes in serum IGF-1 levels and clinical improvement after exercise therapy, and to evaluate the impact of the presence of osteoarthritis metabolic phenotype on this relationship.
Participants will be asked to complete a structured resistance exercise program for 8 weeks.
Researchers will compare the pre-exercise and post-exercise serum IGF-1 levels, clinical scores (WOMAC, VAS) and radiological findings (MOAKS Osteophyte Score) to determine the effectiveness of the intervention.
Detailed description
Knee osteoarthritis (OA) is a prevalent degenerative joint disease characterized by pain, functional impairment, and cartilage degradation. Resistance exercises are recommended as a core non-pharmacological treatment for knee OA, yet the exact biochemical mechanisms underlying its clinical benefits remain partially understood. Insulin-like Growth Factor 1 (IGF-1) is a critical anabolic biomarker involved in cartilage matrix synthesis and repair. Furthermore, recent studies suggest that knee OA is a heterogeneous disease, and the "metabolic phenotype" (often associated with obesity, dyslipidemia, insulin resistance, or hypertension) may significantly influence systemic inflammation, disease progression, and the patient's response to physical rehabilitation.
This study is designed to measure the changes in serum IGF-1 levels in patients with knee OA following a structured resistance exercise program, investigate the correlation between changes in serum IGF-1 and clinical improvements as well as radiological severity and evaluate the modifying effect of the metabolic phenotype on the relationship between biomarker changes and clinical outcomes.
This is a prospective, single-center, non-randomized clinical trial. Patients diagnosed with knee OA according to the American College of Rheumatology (ACR) criteria, specifically with a radiological severity of Kellgren-Lawrence grade 2 or 3, will be included in the study. Participants will be non-randomly allocated into two predefined groups at baseline:
- Metabolic phenotype group: Patients presenting with a metabolic phenotype. (The metabolic phenotype is defined as the presence of metabolic syndrome, using the 2009 Joint Interim Statement criteria. A clinical diagnosis requires the presence of at least three of the following five criteria:
- Elevated waist circumference (≥ 100 cm in men, ≥ 90 cm in women, based on the 2024 Guidelines of the Society of Endocrinology and Metabolism of Turkey)
- Elevated blood pressure (Systolic ≥ 130 mmHg and/or Diastolic ≥ 85 mmHg) or receiving treatment for hypertension
- Elevated fasting blood glucose (≥ 100 mg/dL) or previously diagnosed with diabetes mellitus.
- Elevated triglycerides (≥ 150 mg/dL) or receiving treatment for hypertriglyceridemia.
- Reduced HDL cholesterol (< 40 mg/dL in men, < 50 mg/dL in women) or receiving treatment for hyperlipidemia.)
- Non-Metabolic Phenotype group: Patients without a metabolic phenotype.
Both groups will receive the exact same intervention. All participants will undergo a supervised resistance exercise program targeting the lower extremities. The program will consist of for a total duration of 8 weeks.
Fasting venous blood samples will be drawn at baseline and post-intervention (at 8 weeks) to measure serum IGF-1 levels. Clinical status will be assessed using standard questionnaires including The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) for pain. Additionally, quadriceps muscle strength will be evaluated using a hand-held dynamometer at baseline and post-intervention. For radiological evaluation, baseline osteophyte scores will be assessed for all patients using the Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) system, based on MRI scans obtained within the past year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study utilizes a non-randomized, parallel assignment model. Participants diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) are allocated into two parallel groups at baseline based on their metabolic status, rather than through randomization. Group 1 consists of patients presenting with a metabolic phenotype (defined as meeting the 2009 Joint Interim Statement criteria for metabolic syndrome). Group 2 consists of patients without this metabolic phenotype. Both parallel groups will concurrently receive the exact same intervention: an 8-week supervised resistance exercise program targeting the lower extremities. This non-randomized parallel model allows researchers to directly compare the pre- and post-intervention changes in serum IGF-1 levels, quadriceps muscle strength, and clinical scores between the two distinct phenotypes. The goal is to determine if the baseline metabolic status influences the biochemical and clinical efficacy of the exercise therapy.
| Arm | Type | Receives |
|---|---|---|
| Metabolic Phenotype Group | Experimental | Behavioral: Resistance Exercise ProgramPatients with knee osteoarthritis who meet the criteria for metabolic syndrome (metabolic phenotype). This group will undergo an 8-week supervised resistance exercise program. |
| Non-Metabolic Phenotype Group | Experimental | Behavioral: Resistance Exercise ProgramPatients with knee osteoarthritis who do not meet the criteria for metabolic syndrome. This group will also undergo the exact same 8-week supervised resistance exercise program. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of knee osteoarthritis according to the American College of Rheumatology (ACR) clinical and radiographic criteria.
- Radiological severity of Kellgren-Lawrence (KL) grade 2 or 3 on standing anteroposterior knee radiographs
- Having a knee magnetic resonance imaging (MRI) scan obtained within the past 1 year
- Age between 40 and 75 years
- Volunteering to participate in the study and signing the informed consent form
Key exclusion criteria (7 listed)
- Receiving intra-articular injections (e.g., corticosteroids, hyaluronic acid, PRP) in the affected knee within the last 6 months
- History of previous major knee surgery, knee arthroplasty, or lower extremity trauma affecting biomechanics
- Diagnosis of rheumatoid arthritis, or other inflammatory joint diseases
- Presence of severe cardiovascular, neurological, or musculoskeletal disorders that would contraindicate or prevent participation in a structured resistance exercise program
- History of malignancy or presence of active malignancy
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 |
|---|---|---|
| Resistance Exercise ProgramA supervised resistance exercise program targeting the lower extremity muscles (including quadriceps). The exercise protocol is applied for a total duration of 8 weeks. | Behavioural | Metabolic Phenotype Group, Non-Metabolic Phenotype Group |
Primary outcome
Serum Insulin-like Growth Factor 1 (IGF-1) Levels
Time frame: Baseline and at 8 weeks
Serum IGF-1 levels will be measured from fasting venous blood samples to evaluate the systemic anabolic response to the resistance exercise program.
2 secondary outcomes
Quadriceps Muscle Strength
Time frame: Baseline and at 8 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time frame: Baseline and at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 39448593Escribano-Nunez A, Cornelis FMF, De Roover A, Sermon A, Cailotto F, Lories RJ, Monteagudo S. IGF1 drives Wnt-induced joint damage and is a potential therapeutic target for osteoarthritis. Nat Commun. 2024 Oct 24;15(1):9170. doi: 10.1038/s41467-024-53604-8.
- Background: PubMed 36801367Jansen NEJ, Molendijk E, Schiphof D, van Meurs JBJ, Oei EHG, van Middelkoop M, Bierma-Zeinstra SMA. Metabolic syndrome and the progression of knee osteoarthritis on MRI. Osteoarthritis Cartilage. 2023 May;31(5):647-655. doi: 10.1016/j.joca.2023.02.003. Epub 2023 Feb 16.
- Background: PubMed 28847624Deveza LA, Melo L, Yamato TP, Mills K, Ravi V, Hunter DJ. Knee osteoarthritis phenotypes and their relevance for outcomes: a systematic review. Osteoarthritis Cartilage. 2017 Dec;25(12):1926-1941. doi: 10.1016/j.joca.2017.08.009. Epub 2017 Aug 25.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the fact that there is no plan or ethical approval to share identified participant data with researchers other than team.
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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.
Kadriye Banu Kuran, MD, Prof. principal investigator
Sisli Hamidiye Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Program in people with Osteoarthritis (Knee) and Metabolic Syndrome (MetS), run by Sisli Hamidiye Etfal Training and Research Hospital 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 7 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bora Şahin, MD, PMR resident physician (+905386673139, borashn55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Insulin-like Growth Factor 1 (IGF-1) Levels (time frame: Baseline and at 8 weeks). 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 NCT07890155, which also lists 3 linked publications.
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 22 Oct 2026.