Clinical trial NCT03895931: Effect of Inpatient Pulmonary Rehabilitation on Frailty in Candidates for Lung-Transplantation
Official title: Effects of Pulmonary Rehabilitation on Frailty in Candidates for Lung Transplantation - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Lung Disease
COPD
ILD
Keywords: Frailty
Lung transplant candidates
Rehabilitation
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 30
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 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.

Eligibility criteria: 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

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 6MWT (Six-Minute-Walking-Test)
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 SPPB) and participation
timeFrame: 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
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
timeFrame: Day 1 and Day 21
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Klinikum Berchtesgadener Land, Schön Kliniken
state: Bayern
Study officials:
affiliation: Philipps University Marburg
name: Klaus Kenn, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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: Wilson ME, Vakil AP, Kandel P, Undavalli C, Dunlay SM, Kennedy CC. Pretransplant frailty is associated with decreased survival after lung transplantation. J Heart Lung Transplant. 2016 Feb;35(2):173-8. doi: 10.1016/j.healun.2015.10.014. Epub 2015 Oct 19.
citation: Singer JP, Diamond JM, Anderson MR, Katz PP, Covinsky K, Oyster M, Blue T, Soong A, Kalman L, Shrestha P, Arcasoy SM, Greenland JR, Shah L, Kukreja J, Blumenthal NP, Easthausen I, Golden JA, McBurnie A, Cantu E, Sonett J, Hays S, Robbins H, Raza K, Bacchetta M, Shah RJ, D'Ovidio F, Venado A, Christie JD, Lederer DJ. Frailty phenotypes and mortality after lung transplantation: A prospective cohort study. Am J Transplant. 2018 Aug;18(8):1995-2004. doi: 10.1111/ajt.14873. Epub 2018 May 14.
citation: Maddocks M, Kon SS, Canavan JL, Jones SE, Nolan CM, Labey A, Polkey MI, Man WD. Physical frailty and pulmonary rehabilitation in COPD: a prospective cohort study. Thorax. 2016 Nov;71(11):988-995. doi: 10.1136/thoraxjnl-2016-208460. Epub 2016 Jun 12.
citation: Singer JP, Soong A, Bruun A, Bracha A, Chin G, Hays SR, Kukreja J, Rigler J, Golden JA, Greenland JR, Garvey C. A mobile health technology enabled home-based intervention to treat frailty in adult lung transplant candidates: A pilot study. Clin Transplant. 2018 Jun;32(6):e13274. doi: 10.1111/ctr.13274. Epub 2018 Jun 20.
citation: Speechley M, Tinetti M. Falls and injuries in frail and vigorous community elderly persons. J Am Geriatr Soc. 1991 Jan;39(1):46-52. doi: 10.1111/j.1532-5415.1991.tb05905.x.
citation: Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
citation: Rockwood K, Song X, Mitnitski A. Changes in relative fitness and frailty across the adult lifespan: evidence from the Canadian National Population Health Survey. CMAJ. 2011 May 17;183(8):E487-94. doi: 10.1503/cmaj.101271. Epub 2011 Apr 26.
citation: McIsaac DI, Taljaard M, Bryson GL, Beaule PE, Gagne S, Hamilton G, Hladkowicz E, Huang A, Joanisse JA, Lavallee LT, MacDonald D, Moloo H, Thavorn K, van Walraven C, Yang H, Forster AJ. Frailty as a Predictor of Death or New Disability After Surgery: A Prospective Cohort Study. Ann Surg. 2020 Feb;271(2):283-289. doi: 10.1097/SLA.0000000000002967.
citation: Cameron ID, Fairhall N, Langron C, Lockwood K, Monaghan N, Aggar C, Sherrington C, Lord SR, Kurrle SE. A multifactorial interdisciplinary intervention reduces frailty in older people: randomized trial. BMC Med. 2013 Mar 11;11:65. doi: 10.1186/1741-7015-11-65.
citation: de Labra C, Guimaraes-Pinheiro C, Maseda A, Lorenzo T, Millan-Calenti JC. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials. BMC Geriatr. 2015 Dec 2;15:154. doi: 10.1186/s12877-015-0155-4.
citation: Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.