COPD Clinical Trial
Official title:
Effects of Pulmonary Rehabilitation on Frailty in Candidates for Lung Transplantation - a Prospective Observational Study
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.
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.
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