Clinical trial NCT04184180: Effects of Inpatient Pulmonary Rehabilitation on Frailty in Patients After Lung-Transplantation
Official title: Effects of an Inpatient Pulmonary Rehabilitation Programme on Frailty in Patients After Lung-Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Lung Disease
COPD
Interstitial Lung Disease
Keywords: lung transplantation
pulmonary rehabilitation
exercise training
frailty
lung diseases
respiratory tract diseases
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited during an inpatient pulmonary rehabilitation programme

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Frailty (SPPB)
timeFrame: Day 1 and Day 21
Secondary outcomes:
measure: Change of Frailty (FFP)
timeFrame: Day 1 and Day 21
measure: Effect of Frailty on Six-Minute-Walking-Test (6MWT)
timeFrame: Day 1 and Day 21
measure: Effect of Frailty on Timed-Up-an-Go-Test
timeFrame: Day 1 and Day 21
measure: Effect of Frailty on Quadriceps-Force
timeFrame: Day 1 and Day 21
measure: Correlation between Frailty-Score (measured by Short physical Performance Battery (SPPB)) and attended exerecise sessions
timeFrame: Day 1 to Day 21
measure: Correlation between Cognitive Status measured by Montreal Cognitive Assessment (MOCA) and Frailty Score
timeFrame: Day 1
measure: Correlation between Cognitive Status measured by Addenbrooke's Cognitive Examination (ACE-R) and Frailty Score
timeFrame: Day 1
measure: Correlation between Social Support and Frailty Score
timeFrame: Day 1 and Day 21
measure: Change of Health related Quality of Life: Chronic Respiratory Questionnaire (CRQ)
timeFrame: Day 1 and Day 21
measure: Change of Fatigue
timeFrame: Day 1 and Day 21
measure: Change of Anxiety/Depression
timeFrame: Day 1 and Day 21
measure: Change of Sleeping Quality: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Day 1 and Day 21
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
Study officials:
References:
citation: Singer JP, Diamond JM, Gries CJ, McDonnough J, Blanc PD, Shah R, Dean MY, Hersh B, Wolters PJ, Tokman S, Arcasoy SM, Ramphal K, Greenland JR, Smith N, Heffernan P, Shah L, Shrestha P, Golden JA, Blumenthal NP, Huang D, Sonett J, Hays S, Oyster M, Katz PP, Robbins H, Brown M, Leard LE, Kukreja J, Bacchetta M, Bush E, D'Ovidio F, Rushefski M, Raza K, Christie JD, Lederer DJ. Frailty Phenotypes, Disability, and Outcomes in Adult Candidates for Lung Transplantation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1325-34. doi: 10.1164/rccm.201506-1150OC.
citation: Milne KM, Kwan JM, Guler S, Winstone TA, Le A, Khalil N, Camp PG, Wilcox PG, Ryerson CJ. Frailty is common and strongly associated with dyspnoea severity in fibrotic interstitial lung disease. Respirology. 2017 May;22(4):728-734. doi: 10.1111/resp.12944. Epub 2016 Nov 9.
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citation: Courtwright AM, Zaleski D, Gardo L, Ahya VN, Christie JD, Crespo M, Hadjiliadis D, Lee J, Molina M, Patel N, Porteous M, Cantu EE, Bermudez C, Diamond JM. Causes, Preventability, and Cost of Unplanned Rehospitalizations Within 30 Days of Discharge After Lung Transplantation. Transplantation. 2018 May;102(5):838-844. doi: 10.1097/TP.0000000000002101.
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