Comparative Effectiveness of High-intensity Aerobic Exercise and Biomechanical Neuromuscular Exercise for Treatment of Knee Osteoarthritis: A Randomised Open Label Trial

Frederiksberg University Hospital1 site in 1 country150 target enrollmentFebruary 23, 2024

ConditionsKnee Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: Frederiksberg University Hospital
Enrollment: 150
Locations: 1
Primary Endpoint: Maximal oxygen consumption (VO2max)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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?

Registry

clinicaltrials.gov

Start Date

February 23, 2024

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Frederiksberg University Hospital

Responsible Party

Principal Investigator

Marius Henriksen

Professor

Frederiksberg University Hospital

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

Outcomes

Primary Outcomes

Maximal oxygen consumption (VO2max)

Time Frame: Baseline and Week 12

Cardiopulmonary exercise test (CPET) on an ergometer bicycle for evaluation maximal oxygen consumption (VO2max) measured in ml/min/kg

Knee pain

Time Frame: Baseline and Week 12

The Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale (KOOS-pain), a disease-specific patient-reported instrument designed to assess knee pain in patients with knee osteoarthritis. The KOOS-pain subscale is scored on a 0-100 scale with 100 indicating no pain and 0 indicating extreme pain.

Secondary Outcomes

Knee pain(Week 8 and week 26)
Body Mass(Baseline, Week 12 and Week 26)
Physical Functioning(Baseline, week 8, week 12 and week 26)
Maximal oxygen consumption (VO2max)(Week 8 and week 26)
Blood Pressure(Baseline, Week 12 and Week 26)
Triglyceride concentration(Baseline, Week 12 and Week 26)
Low Density Lipids (LDL) concentration(Baseline, Week 12 and Week 26)
Cholesterol concentration(Baseline, Week 12 and Week 26)
Glucose concentration(Baseline, Week 12 and Week 26)
HbA1c concentration(Baseline, Week 12 and Week 26)
Patient Global Assessment of disease Impact(Baseline, week 8, week 12 and week 26)
Health related quality of Life and physical and mental well-being (Short Form 12 (SF-12))(Baseline, week 8, week 12 and week 26)