Comparing aerobic and neuromuscular exercise for knee osteoarthritis
Comparative Effectiveness of High-intensity Aerobic Exercise and Biomechanical Neuromuscular Exercise for Treatment of Knee Osteoarthritis: a Randomised Open Label Trial
This study is testing whether a high-intensity workout program can better help people with knee osteoarthritis and heart disease risk feel better than a different exercise program focused on muscle control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Frederiksberg University Hospital Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06170229 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of an education and high-intensity interval training program (eHIIT) with a neuromuscular exercise and education program (NEMEX-e) on symptoms of knee osteoarthritis (OA) and cardiovascular disease risk factors. Participants will be individuals diagnosed with knee OA who also have at least one cardiovascular disease risk factor. The study aims to determine if eHIIT is more effective than NEMEX-e in reducing cardiovascular disease risk and improving knee symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of tibiofemoral knee osteoarthritis and at least one cardiovascular disease risk factor.
Not a fit: Patients who have contraindications to exercise or unstable body weight may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective exercise intervention for patients with knee osteoarthritis, potentially improving their symptoms and reducing cardiovascular disease risk.
How similar studies have performed: Other studies have shown success with similar exercise interventions for knee osteoarthritis, suggesting potential for positive outcomes in this study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Copenhagen
- The Parker Institute, Frederiksberg Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Marius Henriksen, PhD
- Email: marius.henriksen@regionh.dk
- Phone: +4538164160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.