Advanced Lung Disease, COPD, ILD
Conditions
Keywords
Frailty, Lung transplant candidates, Rehabilitation
Brief 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.
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 \[6-9\]. 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.
Interventions
None listed
Sponsors
Schön Klinik Berchtesgadener Land
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Frailty (SPPB) | Day 1 and Day 21 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Frailty on 6MWT (Six-Minute-Walking-Test) | Day 1 and Day 21 | Frailty measured by SPPB |
| Effect of Frailty on Timed-Up-an-Go-Test | Day 1 and Day 21 | Frailty measured by SPPB |
| Effect of Frailty on Quadriceps-Force | Day 1 and Day 21 | Frailty measured by SPPB |
| Correlation between Frailty-Score (measured by SPPB) and participation | Day 21 | Participation measured by number of attended exercise training units. |
| Correlation between Cognitive Status measured by Montreal Cognitive Assessment (MOCA) and Frailty Score | Day 1 | 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 |
| Change of Frailty (FFP) | Day 1 and Day 21 | 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 |
| Correlation between Social Support and Frailty Score | Day 1 and Day 21 | 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 |
| Change of Health related Quality of Life | Day 1 and Day 21 | 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 |
| Change of Fatigue | Day 1 and Day 21 | 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 |
| Change of Anxiety/Depression | Day 1 and Day 21 | 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 |
| Change of Sleeping Quality | Day 1 and Day 21 | measured by Pittsburgh Sleep Quality Index (PSQI) - self-report questionnaire including seven components; score 0-21; lower scores indicating better sleep quality |
| Correlation between Cognitive Status measured by Addenbrooke's Cognitive Examination (ACE-R) and Frailty Score | Day 1 | 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 |
Countries
Germany
Outcome results
None listed