Aerobic Vs Neuromuscular Exercise for Knee OA (CANO)

Frederiksberg University Hospital

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Behavioral: NEMEX-e; Behavioral: eHIIT

Study type: Interventional

Funder types: Other

Identifiers

NCT06170229

PT-2023-DK-3

Details and patient eligibility

About

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?

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Education and High Intensity Interval Training (eHIIT)

Active Comparator group

Description:

1 educational session lasting 1 hour. 12 weeks of supervised High Intensity Interval Training (HIIT) 3 times/week.

Treatment:

Behavioral: eHIIT

Neuromuscular exercise and education program (NEMEX-e)

Active Comparator group

Description:

2 educational sessions lasting 1 hour each. 8 weeks of supervised Neuromuscular Exercise 2 times/week.

Treatment:

Behavioral: NEMEX-e