ILD Clinical Trial - Effect of Inpatient Pulmonary Rehabilitation on

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03895931
Study type	Observational
Source	Schön Klinik Berchtesgadener Land
Contact
Status	Completed
Phase
Start date	December 3, 2019
Completion date	March 31, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Inpatient Pulmonary Rehabilitation on Frailty in Candidates for Lung-Transplantation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms