The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
研究概览
简要总结
Exercise is considered the most effective, non-drug treatment for reducing pain and improving movement in patients with osteoarthritis. Diminished muscle strength is a common symptom associated with the onset of knee osteoarthritis. The evidence supports the benefit of exercise therapy, in reducing pain and improving function in subjects with knee OA, however research to date has been unable to quantify the disease-modifying effect of any form of exercise. The primary objective of this study is to evaluate how the use of a seated compact elliptical machine (Cubii JR1) exercise program in conjunction with a standard physical therapy regimen will impact the health of individuals with knee osteoarthritis.
详细描述
Objective
The primary objective of this study is to evaluate how the use of a seated compact elliptical machine (Cubii JR1) exercise program in conjunction with a standard physical therapy regimen will impact the health of individuals with knee osteoarthritis. This includes a range of motion of the knee and ankle, level of pain as measured using a standard questionnaire, muscle strength as well as satisfaction scores with this device. This study will contain two groups: A control group receiving a standard physical therapy exercise program instruction, and a treatment group that will receive standard physical therapy exercise program instruction in conjunction with a home exercise program using a seated compact elliptical machine (Cubii JR1).
Hypothesis
The hypothesis is that subjects with knee osteoarthritis who use the at-home seated compact elliptical trainer for a minimum of 30-minutes per day in conjunction with standard physical therapy program instruction will have a greater reduction in pain, increased range of motion at the knee, and ankle joint, increase in quality of life and greater quadriceps and hamstring muscle strength than those who receive just the standard physical therapy program instruction.
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
- Single (Investigator)
盲法说明
The Principal Investigator will be masked to the patient treatment group assignment.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Diagnosis of unilateral or bilateral knee osteoarthritis
- •Clinical AND/OR radiographic knee osteoarthritis.
- •Clinical radiographic knee osteoarthritis: Symptoms of 2 or more knee pain, morning stiffness in the joint, crepitus on active movement, tenderness of the joint, bony enlargement of the joint, and lack of palpable warmth of the synovium
- •Radiographic knee osteoarthritis: Kellgren-Lawrence score of 2 or greater using radiographs of the involved knee
- •If the participant has had diagnostic radiographs within the previous 2 years at Shirley Ryan AbilityLab, we will use these previous radiographs to confirm diagnosis (these participants will complete a HIPAA authorization form so that we can access these images).
- •If the participant has not had a diagnostic radiograph within the previous 2 years, the participant will complete a bilateral standing anteroposterior radiograph for the purpose of this study. These images are consistent with clinical care for diagnostic OA and minimally expose the individual to radiation (see attached form from radiology technician). All images taken as part of the study will be stored using the assigned study identifier, and therefore will not require any HIPAA authorization.
- •Ability to walk without the use of aids (e.g., cane, walker)
排除标准
- •Age < 50 years
- •History of lower extremity total joint arthroplasty
- •Current cardiovascular disease or hypertension that is uncontrolled
- •History of neurological disorder that effects lower extremity function (i.e., stroke, peripheral neuropathy, multiple sclerosis, Parkinson's disease)
- •Current ankle or hip pain
- •Currently pregnant for female participants
- •Weight over 400 lbs (181.4 kg), height less than 4'8" (142 cm) or over 6'4" (193 cm), 18.5" (47 cm) hip width, or 58" (147 cm) hip circumference
结局指标
主要结局
Change in Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
时间窗: Comparison between day 0, week 4, and week 8
Measured by the Pain Knee injury and Osteoarthritis Outcome Score subscale (KOOS subscales) as a comparison between different groups of the evolution of pain between Day 0 and Week 8. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
次要结局
- Change in Function(Comparison between day 0, week 4, and week 8)
- Participant Exercise Log(8 weeks)
- System Usability Scale (for intervention group)(At 8 week evaluation visit)
- Quality of life measured using the EQ5D survey (Change is assessed)(Comparison between day 0, week 4, and week 8)
- Impact of Osteoarthritis on Quality of Life (Change in KOOS subscale is assessed)(Comparison between day 0, week 4, and week 8)
- Need for medication to treat knee osteoarthritis symptoms (Change is assessed)(Comparison between day 0, week 4, and week 8)
- Change in Symptoms(Comparison between day 0, week 4, and week 8)
- Change in strength measure of the quadriceps and hamstring muscles(Comparison between day 0, week 4, and week 8)
- Change in walking speed(Comparison between day 0, week 4, and week 8)
- Change in walking endurance(Comparison between day 0, week 4, and week 8)
- Stair negotiation (Change is assessed)(Comparison between day 0, week 4, and week 8)
- 5 times sit-to-stand (Change is assessed)(Comparison between day 0, week 4, and week 8)
- Patient satisfaction(At 8 week evaluation visit)
研究者
Prakash Jayabalan MD, PhD
Director, Clinical Musculoskeletal Research
Shirley Ryan AbilityLab