Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Changes from baseline to 12 month follow-up (primary endpoint) in the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL function subscale
研究概览
简要总结
The EDUEX trial will determine whether the addition of progressive resistance training (PRT) to a patient education program (EDU) will improve clinical outcomes in patients with hip OA.
In a subsample, the effect of PRT on the articular cartilage and other structures of the hip joint is investigated. In this subsample, a comprehensive assessment of possible mechanisms underlying the effects of exercise on pain and function is undertaken.
The EduEx trial will be a multicentre, stratified (by site), block randomized (allocation 1:1), controlled, parallel-group superiority trial. 150 people with hip OA will be recruited from hospitals, physiotherapy clinics, social media and newspapers. Participants will be randomized to PRT and EDU or EDU alone. All 150 participants will be included in the clinical evaluation study (CLIN). The last 40 participants randomized to PRT+EDU and to EDU, respectively, will also be included in the mechanistic (MECH) evaluation study (n=80), by being asked to participate in additional outcome assessments. The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study, while a secondary endpoint will be the 3-month follow-up.
详细描述
DESIGN
The EduEx trial will be a multicentre, stratified (by site), block randomized (allocation 1:1), controlled, parallel-group superiority trial. 150 people with hip OA will be recruited from the Orthopedic Departments at hospitals and from physiotherapy clinics, social media and newspapers. Participants will be randomized to PRT+EDU or EDU.
All 150 participants will be included in the clinical evaluation study (CLIN) while only the last 40 participants randomized to PRT+EDU and EDU, respectively, will also be included in the mechanistic evaluation study (MECH, n=80), by being asked to participate in additional outcome assessments including magnetic resonance imaging of the hip.
The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study, while the secondary endpoint will be the 3-month follow-up.
RANDOMIZATION
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with hip OA according to the criteria by the National Institute for Health and Care Excellence (NICE)
- •Radiographic verification of hip OA diagnosis with Kellgren Lawrence score of 2 or 3 in one or both hips
- •Not scheduled for a total hip replacement within the following 12 months
- •An event of hip pain every day of at least 3 out of 10 on a numerical rating scale during the last 14 days
- •Age ≥ 45 years
- •Adequacy in written and spoken Danish
排除标准
- •Comorbidity that markedly influences hip function or degeneration of tissue in or around the hip joint (rheumatic, neurological, mental or other)
- •Surgery in the lower extremities within the six months prior to inclusion
- •BMI > 40
- •Pregnancy
- •Resistance exercise (weights or elastic bands) for the lower extremities exceeding 12 sessions over the last 6 months or 6 sessions over the last 3 months
- •Suffering from claustrophobia or not tolerating whole body MRI scanner
- •Metallic implants from the waist to just above the knee
- •Pacemaker or other medical devices that are not MR approved
研究组 & 干预措施
PRT + EDU
干预措施: PRT (Other)
PRT + EDU
干预措施: EDU (Other)
EDU
干预措施: EDU (Other)
结局指标
主要结局
Changes from baseline to 12 month follow-up (primary endpoint) in the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL function subscale
时间窗: Measured at baseline, 12 weeks and 12 month follow-up
Primary outcome for the CLIN study and secondary outcome for the MECH study. The HOOS ADL function subscale is a 17-item patient-reported outcome measure designed to assess ADL function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better ADL function status.
Changes from baseline to 12-month follow-up (primary endpoint) in the hip articular cartilage of the index hip measured by MRI T2 relaxation time mapping.
时间窗: Measured at baseline and 12 month follow-up
Primary outcome for the MECH study
次要结局
- Changes in the Scoring Hip Osteoarthritis with MRI (SHOMRI) semiquantitative scoring system for evaluating imaging features relevant to the severity and progression of osteoarthritis(Measured at baseline and 12 month follow-up)
- Change in the HOOS Pain subscale(Measured at baseline, 12 weeks and 12 month follow-up)
- Change in the HOOS Hip-related Quality of Life subscale(Measured at baseline, 12 weeks and 12 month follow-up)
- Changes from baseline to 12-month follow-up (primary endpoint) in the articular cartilage of the index hip measured by MRI T1rho relaxation time mapping.(Measured at baseline and 12 month follow-up)
- Change in the HOOS Symptoms subscale(Measured at baseline, 12 weeks and 12 month follow-up)
- Change in the HOOS Sport/recreation subscale(Measured at baseline, 12 weeks and 12 month follow-up)
- Change in the 30 second chair stand test(Measured at baseline, 12 weeks, and 12 month follow-up)
- Change in the 9-step stair climb test(Measured at baseline, 12 weeks, and 12 month follow-up)
- Change in the 40 meter fast-paced walk test(Measured at baseline, 12 weeks, and 12 month follow-up)
- Number of treatment responders according to OMERACT-OARSI response criteria(Measured at 12 weeks and 12 month follow-up)