Effects of Pulmonary Rehabilitation on Frailty in Candidates for Lung Transplantation - a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of Frailty (SPPB)
研究概览
简要总结
Frailty in lung transplant candidates increases the risk of delisting and adverse transplantation outcome [1]. Furthermore, preoperative frailty is associated with a higher one-year-mortality rate after transplantation in frail compared to non-frail candidates. Mortality increases with severity of frailty [2,3].
Decreasing the frailty-status of a LTx-candidate is therefore an approach to improve the pre- and also posttransplant situation. There is some evidence that frailty in LTx-candidates can be decreased by a homebased Rehabilitation [5]. However, at the moment these possible benefits are unknown for an inpatient rehabilitation. Therefore the aim of this study is to observe the effect of a three-week inpatient rehabilitation on frailty in lung transplant candidates.
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 [6-9]. 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 [10-12]. A recent prospective cohort study in the UK observed a significant decrease of frailty in patients with COPD participating at an inpatient rehabilitation programme [4]. Singer et al. (USA) could detect a significant decrease of frailty by a homebased training for LTx-candidates [5].
Aim of this study is to investigate the effects of a three-week inpatient rehabilitation programme on physical frailty (measured by Short Physical Performance Battery) in lung transplant candidates. 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:
This study is a prospective observational trial. The number of 32 participants is based on a sample size calculation. Asssessments will take place in the beginning of rehabilitation programme and at discharge.
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)
- •Lung Transplant candidates (already listed or listed during rehabilitation)
- •Indication: COPD or ILD
- •written informed consent
排除标准
- •Non compliance at assessments
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; test persons with a SPPB-score of 10-12 are considered as "non-frail", a score of 8-9 is considered as "prefrail", a score lower than 8 is considered as "frail"
次要结局
- Correlation between Cognitive Status measured by Montreal Cognitive Assessment (MOCA) and Frailty Score(Day 1)
- Change of Fatigue(Day 1 and Day 21)
- Change of Sleeping Quality(Day 1 and Day 21)
- Change of Frailty (FFP)(Day 1 and Day 21)
- Correlation between Cognitive Status measured by Addenbrooke's Cognitive Examination (ACE-R) and Frailty Score(Day 1)
- Correlation between Social Support and Frailty Score(Day 1 and Day 21)
- Change of Anxiety/Depression(Day 1 and Day 21)
- Effect of Frailty on 6MWT (Six-Minute-Walking-Test)(Day 1 and Day 21)
- Change of Health related Quality of Life(Day 1 and Day 21)
- Effect of Frailty on Timed-Up-an-Go-Test(Day 1 and Day 21)
- Effect of Frailty on Quadriceps-Force(Day 1 and Day 21)
- Correlation between Frailty-Score (measured by SPPB) and participation(Day 21)
研究者
Klaus Kenn
Professor Dr. med. Klaus Kenn
Schön Klinik Berchtesgadener Land