NCT06170229 Aerobic Vs Neuromuscular Exercise for Knee OA
| NCT ID | NCT06170229 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Frederiksberg University Hospital |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-02-23 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-02-23 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to compare the effects of an education and High Intensity Interval Training program (eHIIT) with the widely used Neuromuscular Exercise and education program (NEMEX-e) on knee OA symptoms and risk factors for cardiovascular disease in people with knee OA and at least one risk factor for developement of cardiovascular disease. The main research questions the study aims to answer are: * Is the eHIIT program better than the NEMEX-e program for reducing the risk of cardiovascular disease? * Are the two programs equally good at providing improvement in knee symptoms?
Eligibility Criteria
Inclusion Criteria: * Age ≥18- years * Diagnosis of tibiofemoral knee OA according to the American College of Rheumatology criteria * Radiographically confirmed diagnosis of tibiofemoral OA based on radiographs not older than 6 months. * Average knee pain level ≥ 4 (0=No pain and 10=Worst pain) over the past week (7 days) * At least one of following risk factors for development of cardiovascular disease: * Body mass index ≥ 30 kg/m2 * Hypertension (or in treatment of): Systolic ≥ 135 and/or diastolic ≥ 85 mm Hg * Elevated HbA1c (or in treatment of): ≥ 130.7 mg/dL (44 mmol/mol) * Elevated Triglycerides (or in treatment of): ≥ 150 mg/dL (1.7 mmol/L) * Elevated Cholesterol (or in treatment of) (Low density lipides, LDL): LDL ≥ 54 mg/dL (3.0 mmol/L) Exclusion Criteria: * Contraindication to exercise (e.g., resting systolic blood pressure \> 200 or diastolic blood pressure \> 115, acute or reoccurring chest pain) * Unstable body weight the last 3 months (gain/loss outside +/- 5 kg) * Planned weight loss (non-pharmacological, pharmacological, and surgical) during study participation * Known current cancer * Major cardiovascular event within the last 5 years * Insulin dependent type 1 or type 2 diabetes * Psoriatic, rheumatoid, or gouty arthritis disease * Generalized pain syndromes such as fibromyalgia * Lumbar or cervical nerve root compression syndromes * Scheduled surgery during study participation * Treatment with biological medication * Impairments that prevent performance in high intensity aerobic exercise * Current or planned participation in other health research intervention studies * Pregnant/considering pregnancy * Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as a large knee joint effusion, uncontrolled diabetes/hypertension, psychiatric or cognitive disorders, language barriers, or opiate dependency.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06170229 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06170229 currently recruiting?
Yes, NCT06170229 is actively recruiting participants. Contact the research team at marius.henriksen@regionh.dk for enrollment information.
Where is the NCT06170229 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06170229 clinical trial?
NCT06170229 is sponsored by Frederiksberg University Hospital. The trial plans to enroll 150 participants.