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

COPD Clinical Trial

Official title:

Effects of Pulmonary Rehabilitation on Frailty in Candidates for Lung Transplantation - a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895931
• Other study ID #: Frailty pre-LTX
• Status: Completed
• Start date: December 3, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: September 2020
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Lung Disease
• COPD
• Frailty
• ILD
• Lung Diseases

Locations

Country	Name	City	State
Germany	Klinikum Berchtesgadener Land, Schön Kliniken	Schönau am Königssee	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

References & Publications (12)

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. — View 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. — View Citation

de Labra C, Guimaraes-Pinheiro C, Maseda A, Lorenzo T, Millán-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. Review. — View 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. — View 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. — View Citation

McIsaac DI, Taljaard M, Bryson GL, Beaulé PE, Gagné S, Hamilton G, Hladkowicz E, Huang A, Joanisse JA, Lavallée 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of Frailty (FFP)	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"	Day 1 and Day 21
Secondary	Effect of Frailty on 6MWT (Six-Minute-Walking-Test)	Frailty measured by SPPB	Day 1 and Day 21
Secondary	Effect of Frailty on Timed-Up-an-Go-Test	Frailty measured by SPPB	Day 1 and Day 21
Secondary	Effect of Frailty on Quadriceps-Force	Frailty measured by SPPB	Day 1 and Day 21
Secondary	Correlation between Frailty-Score (measured by SPPB) and participation	Participation measured by number of attended exercise training units.	Day 21
Secondary	Correlation between Cognitive Status measured by Montreal Cognitive Assessment (MOCA) and Frailty Score	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"	Day 1
Secondary	Correlation between Cognitive Status measured by Addenbrooke's Cognitive Examination (ACE-R) and Frailty Score	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"	Day 1
Secondary	Correlation between Social Support and Frailty Score	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	Day 1 and Day 21
Secondary	Change of Health related Quality of Life	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	Day 1 and Day 21
Secondary	Change of Fatigue	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	Day 1 and Day 21
Secondary	Change of Anxiety/Depression	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	Day 1 and Day 21
Secondary	Change of Sleeping Quality	measured by Pittsburgh Sleep Quality Index (PSQI) - self-report questionnaire including seven components; score 0-21; lower scores indicating better sleep quality	Day 1 and Day 21