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

NCT03895931 | Completed

• 1 other identifier: Frailty pre-LTX
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Lung Disease; COPD; ILD

Keywords

Frailty; Lung transplant candidates; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change of Frailty (FFP)

  Day 1 and Day 21

• Effect of Frailty on 6MWT (Six-Minute-Walking-Test)

  Day 1 and Day 21

• Effect of Frailty on Timed-Up-an-Go-Test

  Day 1 and Day 21

• Effect of Frailty on Quadriceps-Force

  Day 1 and Day 21

• Correlation between Frailty-Score (measured by SPPB) and participation

  Day 21

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited during an inpatient pulmonary Rehabilitation Programme.

You may qualify if:

• 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

You may not qualify if:

• Non compliance at assessments

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

Study Sites (1)

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, Bavaria, 83471, Germany

Location

Related Publications (12)

• 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.

  PMID: 26258797 BACKGROUND

• 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.

  PMID: 26679297 BACKGROUND

• 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.

  PMID: 29667786 BACKGROUND

• 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.

  PMID: 27293209 BACKGROUND

• 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.

  PMID: 29742287 BACKGROUND

• 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.

  PMID: 1987256 BACKGROUND

• 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.

  PMID: 20510798 BACKGROUND

• 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.

  PMID: 21540166 BACKGROUND

• 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.

  PMID: 30048320 BACKGROUND

• 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.

  PMID: 23497404 BACKGROUND

• 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.

  PMID: 26626157 BACKGROUND

• 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.

  PMID: 23009149 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Frailty

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Klaus Kenn, Prof. Dr.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med. Klaus Kenn

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 29, 2019
• Study Start: December 3, 2019
• Primary Completion: February 20, 2020
• Study Completion: March 31, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

DE (1)