Home-based Rehabilitation Following a Total Hip Replacement - do Patients Follow the Exercise Prescription and How Does it Relate to Postoperative Recovery? The Pragmatic Home-Based Exercise After Total Hip Arthroplasty Silkeborg 1 (PHETHAS-1) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change in gait speed
研究概览
简要总结
In this study we will investigate the relation between performed exercise dose and recovery after total hip replacement (THA). A dose-response relationship is hypothesized.
It is the primary objective to indicate the preliminary efficacy of home-based rehabilitation using elastic band exercise on performance-based function after THA, based on the relationship between the performed exercise dose (objectively quantified time under tension summary dose) and the change in 40 meter maximal gait speed (performance-based function) from 3 (start of intervention) to 10 weeks (end of intervention) after surgery.
详细描述
The study is a pragmatic, single center, prospective cohort study (single cohort) to be conducted in Silkeborg, Denmark. The outcomes will be collected in the period from 3 to 10 weeks after surgery by an assessor blinded to exercise compliance. The study will adhere methodologically to the STROBE guidelines and checklist for prospective cohort studies (www.strobe-statement.org).
The study design and completion is conducted in a research collaboration between the Interdisciplinary Research Unit at Elective Surgery Centre based at Silkeborg Regional Hospital and Physical Medicine & Rehabilitation Research - Copenhagen (PMR-C) based at Hvidovre Hospital.
Primary objective, eligibility criteria, exposure/intervention and outcome measures are entered elsewhere. At June 28, 2017, two outcome measures were added to the study. At 10 weeks after surgery, patients will be asked both to describe change in hip problems (from preoperatively to 10 weeks after surgery) and to describe their perception of outcome after surgery. The outcome measures will be used for exploratory analysis of patient acceptable symptom state (PASS) and minimal clinically important improvement (MCII)
Primary analysis:
A simple linear regression analysis will be performed to evaluate the association between performed exercise dose and change in score on gait speed. Furthermore descriptive statistics will be used to quantify exercise compliance and to indicate the exercise dosage with the greatest response. Patients will be divided into four compliance-quartiles and summary statistics of the primary outcome (change in gait speed) will be presented graphically to illustrate possible dose-response relationship.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in gait speed
时间窗: Change from 3 to 10 weeks after surgery.
Measured by the 40m fast-paced walk test (continous, m/sec)
次要结局
- Change in hip abductor muscle strength(Change from 3 to 10 weeks after surgery)
- Change in hip flexor muscle strength(Change from 3 to 10 weeks after surgery)
- 24-hour physical activity (mean upright time).(4 weeks after surgery)
- Gait speed(10 weeks after surgery)
- Change in patient-reported function(Change from 3 to 10 weeks after surgery.)
- Change in patient-reported symptoms(Change from 3 to 10 weeks after surgery.)
- Change in patient-reported pain(Change from 3 to 10 weeks after surgery.)
- Change in lower-extremity function(Change from 3 to 10 weeks after surgery)
- Change in patient-reported hip related quality of life(Change from 3 to 10 weeks after surgery.)
- 24-hour physical activity (mean number of steps)(4 weeks after surgery)
- Self-efficacy(3 weeks after surgery)