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Advanced Lung DiseaseNCT03895931

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

An observational study of Advanced Lung Disease and COPD, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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]. Read more about this study

Who is it for?
Any age
Conditions the study is for
Advanced Lung Disease, COPD, ILD
How many people
30 participants
Where
1 siteGermany
Study dates
3 Dec 2019to 31 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants will be recruited during an inpatient pulmonary Rehabilitation Programme.

Who may be able to join

  • 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

Who cannot join

  • Non compliance at assessments

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum Berchtesgadener Land, Schön Kliniken

    Schönau am Königssee, Bavaria, 83471

Other trials in Germany

About this study

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

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.

Read the 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.

Keywords
Frailty, Lung transplant candidates, Rehabilitation
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  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"

    Measured: Day 1 and Day 21

Secondary outcomes (12)

  1. 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"

    Measured: Day 1 and Day 21

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

    Frailty measured by SPPB

    Measured: Day 1 and Day 21

  3. Effect of Frailty on Timed-Up-an-Go-Test

    Frailty measured by SPPB

    Measured: Day 1 and Day 21

  4. Effect of Frailty on Quadriceps-Force

    Frailty measured by SPPB

    Measured: Day 1 and Day 21

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

    Participation measured by number of attended exercise training units.

    Measured: Day 21

  6. 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"

    Measured: Day 1

  7. 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"

    Measured: Day 1

  8. 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

    Measured: Day 1 and Day 21

  9. 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

    Measured: Day 1 and Day 21

  10. 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

    Measured: Day 1 and Day 21

  11. 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

    Measured: Day 1 and Day 21

  12. 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

    Measured: Day 1 and Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study start3 Dec 2019
  3. Primary completion20 Feb 2020
  4. Study completion31 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03895931
Sponsor's protocol ID
Frailty pre-LTX
Status last verified
Sep 2020
First submitted
20 Mar 2019
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26258797

  • 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.

    PubMed 26679297

  • 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.

    PubMed 29667786

  • 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.

    PubMed 27293209

  • 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.

    PubMed 29742287

  • 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.

    PubMed 1987256

  • 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.

    PubMed 20510798

  • 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.

    PubMed 21540166

  • 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.

    PubMed 30048320

  • 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.

    PubMed 23497404

  • 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.

    PubMed 26626157

  • 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.

    PubMed 23009149

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Lung Disease and COPD, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Frailty (SPPB) (time frame: Day 1 and Day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03895931, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.

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