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

NCT04184180 | Completed

• 1 other identifier: Frailty post-LTx
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Lung Disease; COPD; Interstitial Lung Disease

Keywords

lung transplantation; pulmonary rehabilitation; exercise training; frailty; lung diseases; respiratory tract diseases

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

  Day 1 and Day 21

Secondary Outcomes (12)

• Change of Frailty (FFP)

  Day 1 and Day 21

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

  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 Short physical Performance Battery (SPPB)) and attended exerecise sessions

  Day 1 to 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)
• Patient after Lung Transplant (\< 1 year)
• Indication: COPD or ILD
• written informed consent

You may not qualify if:

• Non compliance at assessments
• Re-Transplantation

Sponsors & Collaborators

• Klaus Kenn: lead

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Germany

Location

Related Publications (13)

• 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

• 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.

  PMID: 27860036 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

• 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.

  PMID: 29346256 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

• 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

• 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

• 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; Lung Diseases, Interstitial; Frailty; Lung Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of pulmonary rehabilitation

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: December 3, 2019
• Study Start: December 2, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: November 5, 2021

Record last verified: 2021-11

Locations

DE (1)