Effects of an Inpatient Pulmonary Rehabilitation Programme on Frailty in Patients After Lung-Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change of Frailty (SPPB)
研究概览
简要总结
Frailty is closely linked to the success of lung transplantations (LTx) (1,2). Studies have shown that frailty causes a diminished physical performance in candidates for LTx and an increased 30 day rate of re-hospitalization after surgery. Furthermore, frailty is associated with a higher one-year-mortality rate after LTx in frail compared to non-frail patients (1,3,4).
Some evidence that frailty in LTx-candidates can be decreased by a suitable rehabilitation program suggests that improving the frailty status in post-LTx patients can be a further strategy to contribute to an overall success in LTx. However, at the moment these possible benefits are not investigated yet. Therefore the aim of this study is to observe the effect of a three-week inpatient rehabilitation on frailty in patients after LTx.
详细描述
Rationale:
Frailty is a complex clinical syndrome describing a loss of physical and/or cognitive functionality which leads to a decreased resistance to stressors such as operations or illness. It is associated with increased number of falls, exacerbations, adverse health outcomes and a higher mortality (7-10).
Frail LTx-candidates have a higher risk of being delisted before transplantation, adverse transplantation outcomes and a higher one-year-mortality compared to non-frail candidates. However, studies show that frailty can be decreased by physical training (11-13). A recent prospective cohort study in the UK observed a significant decrease of frailty in patients with COPD participating at an inpatient rehabilitation program (5). Singer et al. (USA) could detect a significant decrease of frailty by a homebased training for LTx-candidates (6).
Aim of this study is to investigate the effects of a three-week inpatient rehabilitation program on physical frailty (measured by Short Physical Performance Battery) in patients after LTx. Additionally, other functional measures as well as the cognitive, social and psychological state will be assessed in order to better understand the complex syndrome of frailty and the effects of rehabilitation.
Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in an inpatient pulmonary rehabilitation programme (Schön Klinik BGL, Germany)
- •Patient after Lung Transplant (< 1 year)
- •Indication: COPD or ILD
- •written informed consent
排除标准
- •Non compliance at assessments
- •Re-Transplantation
结局指标
主要结局
Change of Frailty (SPPB)
时间窗: Day 1 and Day 21
measured by Short Physical Performance Battery (SPPB) including three measurements (Balance, Gait Speed, Chair-Rising-Test); range 0-12, lower scores reflect increased Frailty
次要结局
- Change of Anxiety/Depression(Day 1 and Day 21)
- Change of Sleeping Quality: Pittsburgh Sleep Quality Index (PSQI)(Day 1 and Day 21)
- Effect of Frailty on Six-Minute-Walking-Test (6MWT)(Day 1 and Day 21)
- Effect of Frailty on Timed-Up-an-Go-Test(Day 1 and Day 21)
- Correlation between Frailty-Score (measured by Short physical Performance Battery (SPPB)) and attended exerecise sessions(Day 1 to Day 21)
- Correlation between Social Support and Frailty Score(Day 1 and Day 21)
- Change of Health related Quality of Life: Chronic Respiratory Questionnaire (CRQ)(Day 1 and Day 21)
- Correlation between Cognitive Status measured by Montreal Cognitive Assessment (MOCA) and Frailty Score(Day 1)
- Correlation between Cognitive Status measured by Addenbrooke's Cognitive Examination (ACE-R) and Frailty Score(Day 1)
- Change of Fatigue(Day 1 and Day 21)
- Change of Frailty (FFP)(Day 1 and Day 21)
- Effect of Frailty on Quadriceps-Force(Day 1 and Day 21)
研究者
Klaus Kenn
Professor of pulmonary rehabilitation
Schön Klinik Berchtesgadener Land