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

Study Overview
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Brief Summary
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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
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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 (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.

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

Conditions
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COPD, Advanced Lung Disease, Interstitial Lung Disease

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) Patient after Lung Transplant (< 1 year) Indication: COPD or ILD written informed consent Exclusion Criteria: Non compliance at assessments Re-Transplantation
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 | 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 | Day 1 and Day 21 | 
| Effect of Frailty on Six-Minute-Walking-Test (6MWT) | Frailty measured by Short physical Performance battery (SPPB) | Day 1 and Day 21 | 
| Effect of Frailty on Timed-Up-an-Go-Test | Frailty measured by Short physical Performance battery (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 Short physical Performance Battery (SPPB)) and attended exerecise sessions | Frailty socre will be measured by the Short physical Performance battery (SPPB); attended exercise sessions (number) will be assessed within the pulmonary Rehabilitation Programme. | Day 1 to 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: Chronic Respiratory Questionnaire (CRQ) | 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: Pittsburgh Sleep Quality Index (PSQI) | 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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lung transplantation, pulmonary rehabilitation, exercise training, frailty, lung diseases, respiratory tract diseases