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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Pulmonary Rehabilitation on Frailty in Candidates for Lung Transplantation - a Prospective Observational Study

Conditions
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Advanced Lung Disease, COPD, ILD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Non compliance at assessments
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Frailty (SPPB) | 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 | Day 1 and Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Frailty (FFP) | measured by Fried Frailty Phenotype (FFP), including five constructs (weight loss, exhaustion, physical activity, gait speed and weakness); range 0-5, higher scores reflect increased Frailty: A score of 0 is considered as robust, a score of 1-2 is considered as pre-frail, a score lower than 2 reflects Frailty | Day 1 and Day 21 | 
| Effect of Frailty on 6MWT (Six-Minute-Walking-Test) | Frailty measured by SPPB | Day 1 and Day 21 | 
| Effect of Frailty on Timed-Up-an-Go-Test | Frailty measured by SPPB | Day 1 and Day 21 | 
| Effect of Frailty on Quadriceps-Force | Frailty measured by SPPB | Day 1 and Day 21 | 
| Correlation between Frailty-Score (measured by SPPB) and participation | Participation measured by number of attended exercise training units. | Day 21 | 
| Correlation between Cognitive Status measured by Montreal Cognitive Assessment (MOCA) and Frailty Score | Screening test for detecting cognitive impairment: including testing of orientation, memory, attention, language, visuospatial and executive skills and skills of abstraction; score 0-30; higher scores indicating better cognitive functioning; a score higher than 25 is considered as normal | Day 1 | 
| Correlation between Cognitive Status measured by Addenbrooke's Cognitive Examination (ACE-R) and Frailty Score | the test allows more detailed information about the test person's cognitive functioning: including testing of attention, memory, verbal fluency, language and visuospatial abilities; score 0-100; higher scores indicating better cognitive functioning; a score higher than 86 is considered as normal | Day 1 | 
| Correlation between Social Support and Frailty Score | Social Support measured by Oslo-3-Items-Social-Support Scale (Oslo-3); a 3-item self-report questionnaire ranging 3-14; higher scores reflecting higher social support | Day 1 and Day 21 | 
| Change of Health related Quality of Life | measured by Chronic Respiratory Questionnaire (CRQ) - a 20-item self-report questionnaire; score 1-7; higher scores indicate a better health-related quality of life | Day 1 and Day 21 | 
| Change of Fatigue | measured bei Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) - a self-report questionnaire including 40 items and ranging 0-160; higher scores indicating a higher Quality of life | Day 1 and Day 21 | 
| Change of Anxiety/Depression | Anxiety/Depression measured by Hospital Anxiety and Depression Scale (HADS) - a screening questionnaire including seven questions each about Depression and Anxiety; each part ranging from 0 to 21; higher scores indicate higher presence of the respective state | Day 1 and Day 21 | 
| Change of Sleeping Quality | measured by Pittsburgh Sleep Quality Index (PSQI) - self-report questionnaire including seven components; score 0-21; lower scores indicating better sleep quality | Day 1 and Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Lung transplant candidates, Rehabilitation