The Effect of Hip and Core Muscle Strengthening on Pain, Function, Quality of Life and Movement Patterns in Persons With Patellofemoral Osteoarthritis: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Feasibility (follow-up response): questionnaire
研究概览
简要总结
The purpose of this research is to develop and test the feasibility of an exercise intervention for persons with painful knee osteoarthritis involving the patella (kneecap). Participants in the patellofemoral osteoarthritis (PFOA) group will be treated with a 6-week supervised exercise program that targets strengthening the hip and trunk core muscles. Painfree control participants will attend one session to gather biomechanical, strength, and function data for use in comparison to the patellofemoral osteoarthritis group. Feasibility outcomes include adherence to the treatment program, recruitment, and retention. It is hypothesized that PFOA group participants will change score on a knee pain and function questionnaire by the minimum clinically important difference score for positive improvement at the end of the 6-week intervention program.
详细描述
The investigators propose to develop and test the feasibility of a 6-week supervised hip and core muscle exercise intervention for persons with painful patellofemoral osteoarthritis (PFOA), a common condition for middle-aged and older adults. Currently there is limited evidence regarding effective conservative interventions for PFOA, a chronic condition that is painful and limits function and quality of life. Exercise is recommended as a first-line treatment for knee osteoarthritis, but the optimal type of exercise for PFOA is unknown. This intervention is based upon similar programs shown to improve pain and function in younger persons with patellofemoral pain, a condition that may lead to PFOA. Feasibility outcomes include adherence to the treatment program, recruitment, retention, and the impact of the intervention on participants' pain and function at 6-weeks and 6 months after finishing the program. The investigators will also compare PFOA participants to a matched pain-free volunteer control group to explore the differences in their biomechanics, muscle strength, pain report, and function at baseline. Data from this feasibility study will be used to design a future randomized controlled trial investigating the efficacy of conservative exercise interventions for PFOA. The investigators' overarching goal is to develop a conservative exercise intervention that improves the symptoms, function, and quality of life of persons with PFOA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patellofemoral Osteoarthritis group: 1) age 35-70 years, 2) have been diagnosed with knee osteoarthritis in one or both knees with symptoms primarily in the anterior knee, 3) radiographic evidence of ≥ Grade 1 osteophytes or joint space narrowing at the patellofemoral joint according to the Osteoarthritis Research Society International (OARSI) grading scale (0 = none, 1 = mild/possible, 2 = moderate/definite, 3 = severe), 4) pain produced by ≥ 2 of the following: descending steps, ascending steps, sit-to-stand, squatting, kneeling, prolonged knee flexion, increased activity (e.g., hiking), morning stiffness < 30 minutes, stiffness after sitting ≥ 30 minutes, history of patellar subluxation or dislocation in the past.
- •Control group: 1) age 35-70 years, 2) no known diagnosis by a physician of knee osteoarthritis, 3) pain free in the lower extremities at the time of enrollment into the study and for 1 week prior to enrollment.
排除标准
- •Patellofemoral Osteoarthritis (PFOA) group: 1) the presence of other conditions that may cause knee pain (e.g., patellar tendonitis, rheumatoid arthritis), 2) neurologic or musculoskeletal conditions that may alter lower extremity kinematics (e.g., multiple sclerosis, hip arthritis/arthroplasty), 3) history of a fracture of the knee, 4) pregnancy, 5) knee injections within the past 3 months, 6) inability to understand English.
- •Control group: 1) all previously listed exclusion criteria for the PFOA group, 2) knee pain produced by 2 or more of the following: descending steps, ascending steps, sit-to-stand, squatting, kneeling, prolonged knee flexion, or a history of patellar subluxation or dislocation in the past.
研究组 & 干预措施
Control
Control group, did not undergo intervention.
Exercise group
Experimental, exercise group, underwent intervention
干预措施: Supervised exercise program (Other)
结局指标
主要结局
Feasibility (follow-up response): questionnaire
时间窗: 6 months
Response to 6-month follow-up - return Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (≥ 80% complete and return KOOS): Percentage completion and return for KOOS.
Feasibility (recruitment rates)
时间窗: 4 years
Total number enrolled and total number screened out.
Feasibility (establish viability of underlying treatment model): global rating of change
时间窗: 6 weeks
Response to participation in intervention program in terms of overall rating of change (≥ 80% will achieve Global Rating of Change score ≥ 3 \[scale -5 to 5\] - positive numbers indicate positive change).
Feasibility (adherence)
时间窗: 6 weeks
Adherence to supervised program (≥ 80% complete 10 supervised exercise sessions and 2 data collection sessions): Percentage adherence.
Feasibility (retention rates)
时间窗: 6 weeks
Completion of baseline and 6-week evaluation sessions. Percentage completion for both data collection sessions.
Feasibility (follow-up response): exercise diary
时间窗: 6 months
Response to 6-month follow-up - return exercise diary (≥ 80% complete and return exercise diary): Percentage completion and return for diary.
Feasibility (establish viability of underlying treatment model): pain rating
时间窗: 6 weeks
Response to participation in intervention program in terms of pain rating (≥ 80% will change score on KOOS pain subscale by the minimum clinically important difference score for positive improvement \[positive change of 10 points\] - at the end of the 6-week intervention program).
Feasibility (establish viability of underlying treatment model): activity of daily living rating
时间窗: 6 weeks
Response to participation in intervention program in terms of activity of daily living rating (≥ 80% will change score on KOOS activity of daily living (ADL) subscale by the minimum clinically important difference score for positive improvement \[positive change of 10 points\] - at the end of the 6-week intervention program).
次要结局
- Determine long-term benefits of intervention: pain rating(6 months)
- Determine long-term benefits of intervention: activity of daily living rating(6 months)
- Establish impact of intervention on physical performance(6 weeks)
研究者
Lisa Hoglund
Associate Professor
University of the Sciences in Philadelphia