NCT04184180

Effects of Inpatient Pulmonary Rehabilitation on Frailty in Patients After Lung-Transplantation

Effects of an Inpatient Pulmonary Rehabilitation Programme on Frailty in Patients After Lung-Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Klaus Kenn · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 (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: This study is a prospective observational trial. The number of 30 participants is based on a sample size calculation. Assessments will take place in the beginning of rehabilitation program and at discharge.

Conditions

• Advanced Lung Disease
• COPD
• Interstitial Lung Disease

Timeline

• Start date: 2019-12-02
• Primary completion: 2020-03-16
• Completion: 2020-03-16
• First posted: 2019-12-03
• Last updated: 2021-11-05

Locations

1 site across 1 country: Germany