Aerobic vs Neuromuscular Exercise for Knee OA

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Behavioral: eHIIT; Behavioral: NEMEX-e

• Registration Number: NCT06170229
• Lead Sponsor: Frederiksberg University Hospital

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Study Start: 2024-02-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education and High Intensity Interval Training (eHIIT)	eHIIT	1 educational session lasting 1 hour. 12 weeks of supervised High Intensity Interval Training (HIIT) 3 times/week.
Neuromuscular exercise and education program (NEMEX-e)	NEMEX-e	2 educational sessions lasting 1 hour each. 8 weeks of supervised Neuromuscular Exercise 2 times/week.

Primary Outcome Measures

Name	Time	Method
Maximal oxygen consumption (VO2max)	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	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 Outcome Measures

Name	Time	Method
Knee pain	Week 8 and week 26	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.
Body Mass	Baseline, Week 12 and Week 26	Body mass measured in kilograms using a scale
Physical Functioning	Baseline, week 8, week 12 and week 26	The Knee injury and Osteoarthritis Outcome Score (KOOS) function subscale (KOOS-function), a disease-specific patient-reported instrument designed to assess physical functioning in patients with knee osteoarthritis.; The KOOS-function subscale is scored on a 0-100 scale with 100 indicating no functional impairments and 0 indicating extreme functional impairments.
Maximal oxygen consumption (VO2max)	Week 8 and week 26	Cardiopulmonary exercise test (CPET) on an ergometer bicycle for evaluation maximal oxygen consumption (VO2max) measured in ml/min/kg
Blood Pressure	Baseline, Week 12 and Week 26	Systolic and Diastolic blood pressure
Triglyceride concentration	Baseline, Week 12 and Week 26	From a blood sample
Low Density Lipids (LDL) concentration	Baseline, Week 12 and Week 26	From a blood sample
Cholesterol concentration	Baseline, Week 12 and Week 26	From a blood sample
Glucose concentration	Baseline, Week 12 and Week 26	From a blood sample
HbA1c concentration	Baseline, Week 12 and Week 26	From a blood sample
Patient Global Assessment of disease Impact	Baseline, week 8, week 12 and week 26	Patient-reported degree of patient's perceived impact of their knee OA on their overall life will be obtained using a 100 mm analogue scale (VAS) with anchors: 0=" No impact" and 100 = "Worst imaginable impact".
Health related quality of Life and physical and mental well-being (Short Form 12 (SF-12))	Baseline, week 8, week 12 and week 26	The 12-item short form health questionnaire (SF-12) is a measure of physical and mental health.; The physical health component is scored between 0-72. The mental health component is scored between 0-70. For both components 0 mean a worse outcome.

Trial Locations

Locations (1)

The Parker Institute, Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark