Status:
RECRUITING
Aerobic Vs Neuromuscular Exercise for Knee OA
Lead Sponsor:
Frederiksberg University Hospital
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
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 sympto...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06170229
Start Date
February 23 2024
End Date
December 31 2026
Last Update
September 5 2024
Active Locations (1)
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1
The Parker Institute, Frederiksberg Hospital
Copenhagen, Denmark, 2000