Intensified In-hospital Physiotherapy for Patients After Hip Fracture Surgery (IPPAHS). A Pragmatic, Randomized Feasibility Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total physiotherapy completion rate during hospitalization
研究概览
简要总结
Regaining basis mobility after a hip fracture surgery is an important in-hospital rehabilitation goal because patients who have regained basis mobility at pre-fracture level at discharge have lower 30-day mortality and readmission rate and are more likely to be discharged to their own home. However, at discharge only half of the patients have regained their pre-fracture basis mobility level.
Intensified acute in-hospital physiotherapy (e.g. more than once daily) highlighting weight-bearing activities and ambulation could have a positive effect on the proportion of patients who regain their pre-facture basic mobility at discharge. However, data from daily clinical practice suggest that only half of the patients are able to complete physiotherapy on the first postoperative day and that fatigue, hip fracture-related pain and habitual cognitive status are the most frequent reasons for not completing planned physiotherapy (once daily) during the first three postoperative days. Thus to undertake an RCT investigating the effect of intensified acute in-hospital physiotherapy i.e. two daily sessions of physiotherapy compared to usual care i.e. one daily session, on regained pre-facture basic mobility at discharge in patients with hip fracture raises important practical concerns regarding e.g. completion rate of planned physiotherapy. The potential positive effects of intensified physiotherapy will be hampered if too many patients are unable to complete planned physiotherapy e.g. because of fatigue or pain. Feasibility studies ask whether something can be done and are preliminary studies conducted specifically for the purposes of establishing whether or not a full trial will be feasible to conduct. Thus, the main aim of the trial is to assess the feasibility of conducting a definitive pragmatic RCT in terms of implementation, practicality and acceptability of intensified acute in-hospital physiotherapy i.e. two daily sessions of physiotherapy highlighting weight-bearing activities and ambulation on weekdays among patients with hip fracture.
The main predefined feasibility criterium is that about twice as many physiotherapy sessions are completed in the intensified physiotherapy group compared to in the usual care physiotherapy group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient will be eligible for study participation if he/she meets the following criteria:
- •Diagnosed with an isolated, first time hip fracture on the affected side
- •Age ≥ 65 years
- •Able to speak and understand Danish
- •Home-dwelling with an independent pre-fracture ability to walk indoors (New Mobility Score (NMS) ≥ 2)
- •Able to give written informed consent prior to physiotherapy in the first postoperative day
排除标准
- •A participant will be excluded from the study if he/she meets any of the following criteria:
- •The fracture is pathological (e.g. cancer-based)
- •Postoperative weight-bearing is restricted
- •Multiple body fractures are present
- •Serious postoperative medical complications occur
- •Any other conditions that in the opinion of the investigator makes a potential participant unfit for participation
结局指标
主要结局
Total physiotherapy completion rate during hospitalization
时间窗: Through hospital stay, an average of 8.82 days after admission.
The degree of completion (successful completion, partial completion or cancellation) of every physiotherapy session on weekdays from the first postoperative day to discharge will be rated by the physiotherapists and total physiotherapy completion rate during hospitalization will be calculated. The physiotherapists will also register cause of partial completion or cancellation.
次要结局
- Hip-fracture-related pain during physiotherapy(Through hospital stay, an average of 8.82 days after admission.)
- Fatigue at rest(Through hospital stay, an average of 8.82 days after admission.)
- Basic mobility assessed using The Cumulated Ambulation Score (CAS)(Through hospital stay, an average of 8.82 days after admission.)
- Regain of pre-fracture basic mobility level at discharge(Baseline (pre-fracture) and at discharge an average of 8.82 days after admission)
- Upright time during hospitalization(From the second postoperative day to discharge, though for a maximum of 10 days after surgery.)
- Hip-fracture-related pain at rest(Through hospital stay, an average of 8.82 days after admission.)
- Upright events during hospitalization(From the second postoperative day to discharge, though for a maximum of 10 days after surgery.)
- Fatigue during physiotherapy(Through hospital stay, an average of 8.82 days after admission.)
研究者
Theresa Bieler
Research Therapist
Bispebjerg Hospital