Feasibility and Initial Effects of High Intensity Interval Training on Knee Osteoarthritis: an Exploratory Evaluation on Metabolomics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility - proportion of potential participants screened for the study who are enrolled
研究概览
简要总结
Purpose: The purpose of this study will be to examine the feasibility and acceptability of a 6-week high intensity interval training (HIIT) program in patients with knee OA symptoms ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body metabolism induced by 6-weeks of HIIT.
Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA
Procedures (methods): All participants will be assigned to the single-arm of the study in which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability, feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes will include whole body metabolism markers, inflammation, and a set of physical function including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness, isometric knee extensor and flexor strength (factors associated with physical function and symptomatic knee OA progression), and body composition.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must exhibit symptomatic knee OA (WOMAC > 31), radiographic evidence of tibiofemoral OA (2-4 Kellgren-Lawrence scale)
- •Age 40-70 years
- •Body mass index 20-35 kg/m²
- •Cleared by study physician from 12 lead EKG and medical history review
排除标准
- •Individuals diagnosed with a cardiovascular condition restricting exercise Individuals currently meeting Department of Health and Human Services Guidelines for Physical Activity (meeting >150 minutes of exercise per week)
- •Individuals currently doing HIIT
- •Individuals currently participating in physical therapy for knee OA
- •Individuals currently participating in another OA intervention study
- •Received a corticosteroid or hyaluronic acid injection involved in the knee in the previous 3 weeks or scheduled for during the intervention
- •Diagnosis of gout in the knee
- •Diagnosis of Rheumatoid arthritis
- •Diagnosis of Fibromyalgia
- •Other systemic rheumatic disease
- •Severe dementia or other memory loss
- •Active diagnosis of psychosis or uncontrolled substance abuse disorder
- •Hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 6 months
- •Diabetics (medications include exogenous insulin)
- •Total joint replacement knee surgery, other knee surgery, meniscus tear, or ACL tear in the past 12 months
- •On a waiting list for total joint replacement
- •Severely impaired hearing or speech
- •Pregnant or planning to become pregnant in the next 8 weeks
- •Inability to speak English
- •Serious or terminal illness as indicated by referral to hospice or palliative care
- •Nursing home residence
- •Inability to ride a stationary bike
- •Any other health problems that would prohibit safe participation in the study.
研究组 & 干预措施
High intensity interval training
干预措施: High intensity interval training (Behavioral)
结局指标
主要结局
Feasibility - proportion of potential participants screened for the study who are enrolled
时间窗: baseline
Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing
时间窗: 6 weeks
次要结局
- Whole body metabolism measured by amino acids(6 weeks)
- Whole body metabolism measured by an oral glucose tolerance test(6 weeks)
- Change in Pain score from baseline to 6 weeks(baseline, 6 weeks)
- Change in symptomatic burden score from baseline to 6 weeks(baseline, 6 weeks)
- Body Composition from dual energy x-ray absorptiometry(6 weeks)
- Adherence: total number of training session completed per week(6 weeks)
- Adherence: total number of training weeks completed(6 weeks)
- Whole body metabolism measured by insulin(6 weeks)
- Cardiorespiratory Fitness from peak oxygen consumption test(6 weeks)
- Whole body metabolism measured by free fatty acids(6 weeks)
- Knee Strength (extensors and flexors) from dynamometry(6 weeks)
- Compliance: average number of training session completed per week(6 weeks)
- Inflammation measured from interleukin-6 and tumor necrosis factor alpha(6 weeks)