Clinical trial NCT06170229: Aerobic Vs Neuromuscular Exercise for Knee OA
Official title: Comparative Effectiveness of High-intensity Aerobic Exercise and Biomechanical Neuromuscular Exercise for Treatment of Knee Osteoarthritis: a Randomised Open Label Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Maximal oxygen consumption (VO2max)
timeFrame: Baseline and Week 12
measure: Knee pain
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Maximal oxygen consumption (VO2max)
timeFrame: Week 8 and week 26
measure: Knee pain
timeFrame: Week 8 and week 26
measure: Body Mass
timeFrame: Baseline, Week 12 and Week 26
measure: Blood Pressure
timeFrame: Baseline, Week 12 and Week 26
measure: Triglyceride concentration
timeFrame: Baseline, Week 12 and Week 26
measure: Low Density Lipids (LDL) concentration
timeFrame: Baseline, Week 12 and Week 26
measure: Cholesterol concentration
timeFrame: Baseline, Week 12 and Week 26
measure: Glucose concentration
timeFrame: Baseline, Week 12 and Week 26
measure: HbA1c concentration
timeFrame: Baseline, Week 12 and Week 26
measure: Patient Global Assessment of disease Impact
timeFrame: Baseline, week 8, week 12 and week 26
measure: Physical Functioning
timeFrame: Baseline, week 8, week 12 and week 26
measure: Health related quality of Life and physical and mental well-being (Short Form 12 (SF-12))
timeFrame: Baseline, week 8, week 12 and week 26
Other outcomes:
measure: Knee-related Quality of Life
timeFrame: Baseline, week 8, week 12 and week 26
measure: Knee Symptoms
timeFrame: Baseline, week 8, week 12 and week 26
measure: Knee Function in Sports and Recreational activities
timeFrame: Baseline, week 8, week 12 and week 26
measure: The World Health Organisation - Five Well-Being Index (WHO-5)
timeFrame: Baseline, week 8, week 12 and week 26
measure: OMERACT-OARSI treatment responder criteria
timeFrame: Baseline, week 8, week 12 and week 26
measure: Sleep quality using the global Single-item sleep quality scale (SQS)
timeFrame: Baseline, week 8, week 12 and week 26
measure: Nightly pain
timeFrame: Baseline, week 8, week 12 and week 26
measure: Maximal aerobic capacity (VO2 peak) during a cardiopulmonary exercise test
timeFrame: Baseline, week 8, week 12 and week 26
measure: Maximum work during a cardiopulmonary exercise test
timeFrame: Baseline, week 8, week 12 and week 26
measure: Respiratory exchange ratio (RER) during a cardiopulmonary exercise test
timeFrame: Baseline, week 8, week 12 and week 26
measure: Maximal hear rate during a cardiopulmonary exercise test
timeFrame: Baseline, week 8, week 12 and week 26
measure: Lean body mass from a dual x-ray absorptiometry scan
timeFrame: Baseline, Week 12 and Week 26
measure: Total fat mass from a dual x-ray absorptiometry scan
timeFrame: Baseline, Week 12 and Week 26
measure: Bone mineral density from a dual x-ray absorptiometry scan
timeFrame: Baseline, Week 12 and Week 26
measure: Hip and waist circumstance
timeFrame: Baseline, Week 12 and Week 26
measure: Leg extensor power
timeFrame: Baseline, Week 12 and Week 26
measure: Analgesics usage
timeFrame: Baseline, Week 12 and Week 26
measure: Pressure pain sensitivity
timeFrame: Baseline, Week 12 and Week 26
measure: C-reactive protein concentration
timeFrame: Baseline, Week 12 and Week 26
measure: Interleukin 6 (IL6) concentration
timeFrame: Baseline, Week 12 and Week 26
measure: Seismocardiography - estimate of maximal oxygen consumption (VO2max) during rest.
timeFrame: Baseline, Week 12 and Week 26
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
References: