Comparative Effectiveness of High-intensity Aerobic Exercise and Biomechanical Neuromuscular Exercise for Treatment of Knee Osteoarthritis: A Randomised Open Label Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Maximal oxygen consumption (VO2max)
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Neuromuscular exercise and education program (NEMEX-e)
2 educational sessions lasting 1 hour each. 8 weeks of supervised Neuromuscular Exercise 2 times/week.
干预措施: NEMEX-e (Behavioral)
Education and High Intensity Interval Training (eHIIT)
1 educational session lasting 1 hour. 12 weeks of supervised High Intensity Interval Training (HIIT) 3 times/week.
干预措施: eHIIT (Behavioral)
结局指标
主要结局
Maximal oxygen consumption (VO2max)
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Marius Henriksen
Professor
Frederiksberg University Hospital