Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement. A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Change in gait speed
研究概览
简要总结
Health professions need to prepare for the large increase in the number of older people with OA requiring health services including TJA surgery. Older age and poor physical function influences the postoperative prognosis of TJA. At discharge from hospital after TJA, studies have shown that gait speed can be severely impaired among older patients.
The investigators hypothesize that an exercise program of 6-12 weeks will be beneficial for patients that are undergoing TJA.
详细描述
More than 300.000 Norwegians above 20 years of age have osteoarthritis (OA) . There has been a significant increase in the prevalence of OA over the decades. In the United States knee OA affects 19% of adults aged 45 years or older. OA is associated with an extensive high economic and personal burden, largely attributable to the effects of disability, comorbid disease, and the expense of treatment.
Given the aging population, the number of total joint arthroplasty procedures (TJA) for hip and knee is likely to increase substantially. In light of poor physical function prior to surgery among older patients and the likelihood of an added decrease during hospitalization and risk of poorer outcome after surgery, it is hypothesised that prehabilitation (preoperative exercise) would improve outcomes after surgery, however evidence for its efficacy is still lacking
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 70 years or older living at home with residential address in the county of Oslo or Akershus scheduled for elective primary total hip replacement due to end-stage osteoarthritis.
- •Harris Hip Score >
- •Participants must also be capable in Norwegian and be able to follow exercise sessions.
排除标准
- •Patients with known rheumatoid arthritis or medical contraindications or those who are scheduled for revision of hip arthroplasty
- •Unable to speak and understand the Norwegian language.
- •Patients with neurological disorders affecting gait
- •Medical contraindications for exercise
结局指标
主要结局
Change in gait speed
时间窗: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
40 meters Fast-Paced Walk test
次要结局
- Change in physical function(Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention)
- Length of stay in hospital(From date of hospital admission until the date of hospital discharge, assessed up to 12 months)
- Change in transitional ambulation(Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention)
- Change in pain measured with numeric rating scale (NRS)(Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention)
- Change in aerobic capacity(1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery)
- Change in the ability to climb stairs(Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention)
- Change in Health Status measured with EuroQol-5 dimensions (EQ-5D)(Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention)