Effect of an Exercise Intervention Targeting Hip Strengthening in Patients Undergoing Revision Total Hip Replacement - a Multicenter, Randomized Controlled Trial (The Strong Hip Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 9
- 主要终点
- Change in functional performance measured by the 30-seconds chair stand test
研究概览
简要总结
There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR. Further, patients undergoing revision THR achieve worse clinical outcomes on hip pain and function compared to patients undergoing primary THR. The primary aim of this randomized controlled trial is to compare the clinical effectiveness of a partly tele-delivered exercise intervention targeting hip strengthening with the standard community-based rehabilitation (usual care) in patients undergoing revision THR. The investigators will test the hypothesis that the exercise intervention targeting hip strengthening is superior to standard community-based rehabilitation in improving physical function measured with the 30-second Chair Stand Test at 16-week follow-up.
详细描述
There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR. Revision THR is one of the more technically challenging orthopedic surgeries and patients undergoing revision THR report improvements in pain and function. Nevertheless, patients undergoing revision THR achieve worse clinical outcomes on hip pain and function compared to patients undergoing primary THR. This calls for research exploring different rehabilitation approaches, in order to improve clinical outcomes for patients after revision THR.
This study aims to compare the clinical effectiveness of a partly tele-delivered exercise intervention targeting hip strengthening with the standard community-based rehabilitation (usual care) in patients undergoing revision THR.
This randomized, controlled, assessor-blinded trial is a multicenter trial involving hospitals and municipality rehabilitation centers across Denmark. Eligible patients undergoing revision THR will be randomized into two groups: A partly remotely-delivered hip strengthening rehabilitation intervention (strength group) or usual care (control group).
The exercise intervention targeting hip strengthening will partly follow the Neuromuscular Exercise (NEMEX) program as described by Eva Ageberg et al., and the intervention is further modified based on expert opinion from patients' experience with rehabilitation from a prior qualitative study. Usual care consists of rehabilitation in the municipalities, where it is up to the individual physiotherapist and the municipality to organize the rehabilitation, which is why both type, content, and duration may vary.
The primary outcome will be change in functional performance measured by the 30-second Chair Stand Test. Outcomes will be measured at baseline, after 16 weeks of intervention, and at 12-month follow-up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing first revision THR
- •Age ≥ 18 years
- •Motivated to participate in an exercise program for 16 weeks
- •Provided informed consent to participate
- •Patients who has the cup and/or stem replaced or a combination of liner and caput replaced
- •Patients who can be baseline tested (chair stand test, stair climb test, 40m walking test)
排除标准
- •Dependency of wheelchair
- •Preplanned other lower limb surgery within 12 months
- •Body Mass Index (BMI) score > 40
- •Currently undergoing cancer treatment, e.g. chemo-, immuno-, or radiotherapy.
- •Comorbidities that prevent exercise
- •Inadequacy in written and spoken Danish
- •Mentally unable to participate
研究组 & 干预措施
Strength group
Group 1
干预措施: Exercise Intervention Targeting Hip Strengthening (Other)
Control group
Group 2
干预措施: Usual Care (Other)
结局指标
主要结局
Change in functional performance measured by the 30-seconds chair stand test
时间窗: Measured at baseline, 16-week, and 12-month follow-up.
The 30-second chair stand test is a valid and reliable measure of lower-extremity muscle strength evaluating sit-to-stand function, which is limited in people undergoing hip replacement.
次要结局
- Change in the HOOS symptoms subscale(Measured at baseline, 16-week, and 12-month follow-up.)
- Change in the HOOS activities of daily living (ADL) function subscale(Measured at baseline, 16-week, and 12-month follow-up.)
- Change in 9-step Timed Stair Climb Test (9-step TSCT)(Measured at baseline, 16-week, and 12-month follow-up.)
- Adherence to the 16-week intervention(Registered throughout the 16-week initial intervention.)
- Global Perceived Effect (GPE)(Measured at 16-week and 12-month follow-up.)
- AE (Adverse Events) & Serious Adverse Events (SAE)(Registered throughout the 12-month study period.)
- Drop-outs(Registered throughout the 12-month study period.)
- Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale(Measured at baseline, 16-week, and 12-month follow-up.)
- Change in 40m Fast-Paced Walk Test (40m-FPWT)(Measured at baseline, 16-week, and 12-month follow-up.)
- Change in the HOOS quality-of-life subscale(Measured at baseline, 16-week, and 12-month follow-up.)
- Change in the HOOS sports and recreation subscale(Measured at baseline, 16-week, and 12-month follow-up.)
- Change in leg extension muscle power (watt/kg body weight)(Measured at baseline, 16-week, and 12-month follow-up.)