Tolerability of High Intensity Aerobic Exercise for Patients With Knee Osteoarthritis and Cardiovascular Disease Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Knee flares
研究概览
简要总结
Background: Current knee osteoarthritis (OA) guidelines recommend knee specific exercise as treatment for knee OA pain. However, up to 87 % of patients with knee OA have at least one other chronic condition, typically cardiovascular in nature. The elevated risk of cardiovascular health problems can be mitigated by performing aerobic exercise. By consequence, it seems logical to apply aerobic exercise for this patient group as the symptomatic benefit is equal to other types of exercise.
Aim: This study aims to assess the tolerability of cardiovascular exercise using High Intensity Interval Training (HIIT) on different self-selected exercise equipment in patients with knee OA and at least one CVD risk factor.
Hypothesis: The hypothesis is that performing HIIT exercise is tolerable when having knee OA and at least one CVD risk factor.
Method:
The study is a prospective cohort study designed to assess if HIIT performed by patients with knee OA and at least one modifiable CVD risk factor influence knee pain. The investigators plan to include 40 participants. The participants will be recruited from the osteoarthritis outpatient clinic at Bispebjerg-Frederiksberg hospital.
This study will include participants with a clinical diagnosis of knee OA (either one or both knees) and at least one CVD risk factor (obesity, hypertension, elevated HbA1c (long-term blood glycose), elevated triglycerides, elevated cholesterol (LDL)). All participants will attend the HIIT intervention 3 times per week, for 12 weeks. Before a participant attend their first exercise session, he/she will be asked to complete an educational session about knee OA and aerobic exercise.
Participants will have a pre-screening visit (phone call), a screening visit, and a baseline visit, before the 12-week exercise period (3 sessions weekly), and after completion of the exercise period a follow-up visit.
Finance: This study is fully funded by Sygesikring "Denmark".
Publication: All results, both negative, positive, and inconclusive will be published. Should publication fail, the results will be made publicly available.
详细描述
BACKGROUND Current knee osteoarthritis (OA) treatment guidelines recommend knee specific exercise as treatment for knee OA pain. If performed regularly, such knee-specific exercise can yield a small to moderate effect on knee OA pain. However, muscle strengthening and neuromuscular exercise are not the only types of exercise that can reduce knee pain; walking regularly or aerobic exercise have similar positive effects on knee OA pain.
Up to 87 % of patients with knee OA have at least one other chronic condition. In the OA population abdominal obesity and metabolic syndrome are more prevalent than in the general population and knee OA is associated with increased risk for all-cause and cardiovascular (CV) death.
It therefore seems logical to apply aerobic exercise for this patient group as the symptomatic benefit is equal to other types of exercise.
AIM This study aims to assess the tolerability of cardiovascular exercise using High Intensity Interval Training (HIIT) on different self-selected exercise equipment in patients with knee OA and at least one CVD risk factor.
STUDY DESIGN The study is a prospective cohort study designed to assess if High Intensity Interval Training (HIIT) performed by patients with knee OA and at least one modifiable CVD risk factor influence knee pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with knee OA
- •At least one of the following CVD risk factors: Overweight/obesity, hypertension, elevated HbA1c, elevated triglycerides, High LDL
- •Age > 18
- •Willing and able to understand and participate in the study
排除标准
- •Contraindication to exercise (e.g. resting systolic blood pressure > 200 or diastolic blood pressure > 115, acute or reoccurring chest pain)
- •Major cardiovascular event within the last 5 years
- •Planning to start another treatment for their knee OA during the study participation period
- •Performing at least 150 minutes of moderate intensity activities or ≥ 75 minutes of vigorous activity weekly
- •Insulin dependent type I or type II diabetes
- •Scheduled surgery during study participation
- •Evidence of other inflammatory joint disease (e.g., rheumatoid arthritis or gout)
- •Generalized pain syndromes such as fibromyalgia
- •Lumbar or cervical nerve root compression syndromes
- •Other musculoskeletal, neurological, or medical condition precluding participation to aerobic exercise
- •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 disorders, or opiate dependency.
结局指标
主要结局
Knee flares
时间窗: from exercise week 1-12
number of knee flares reported during the exercise period, a flare is defined at an increase of minimum 2 on a numeric rating scale from 0-10
Average knee pain
时间窗: from exercise week 1-12
reported average knee pain from first to last exercise session on a numeric rating scale from 0-10
Attendance
时间窗: from exercise week 1-12
number of attended sessions during the exercise period
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(baseline (week 0) and follow-up (week 13))
- Blood sample (cholesterol)(baseline (week 0) and follow-up (week 13))
- Completion of the HIIT protocol(from exercise week 1-12)
- PainDETECT Questionnaire(baseline (week 0))
- Blood sample, HbA1c(baseline (week 0) and follow-up (week 13))
- Blood pressure(baseline (week 0) and follow-up (week 13))
- Cardiopulmonary test (Vo2peak)(at baseline (week 0) and after completion of the exercise period (week 13))
- Weight(baseline (week 0) and follow-up (week 13))
- Analgesics use(baseline (week 0) and follow-up (week 13))
- Blood sample (triglycerides)(baseline (week 0) and follow-up (week 13))
研究者
Cecilie Bartholdy
Post Doc
Frederiksberg University Hospital