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

September 2, 2020 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- Bayern
  - Schönau am Königssee, Bayern, Germany, 83471
    - Klinikum Berchtesgadener Land, Schön Kliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited during an inpatient pulmonary Rehabilitation Programme.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Frailty (SPPB) Time Frame: Day 1 and Day 21	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Frailty (FFP) Time Frame: Day 1 and Day 21	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
Effect of Frailty on 6MWT (Six-Minute-Walking-Test) Time Frame: Day 1 and Day 21	Frailty measured by SPPB	Day 1 and Day 21
Effect of Frailty on Timed-Up-an-Go-Test Time Frame: Day 1 and Day 21	Frailty measured by SPPB	Day 1 and Day 21
Effect of Frailty on Quadriceps-Force Time Frame: Day 1 and Day 21	Frailty measured by SPPB	Day 1 and Day 21
Correlation between Frailty-Score (measured by SPPB) and participation Time Frame: Day 21	Participation measured by number of attended exercise training units.	Day 21
Correlation between Cognitive Status measured by Montreal Cognitive Assessment (MOCA) and Frailty Score Time Frame: Day 1	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
Correlation between Cognitive Status measured by Addenbrooke's Cognitive Examination (ACE-R) and Frailty Score Time Frame: Day 1	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
Correlation between Social Support and Frailty Score Time Frame: Day 1 and Day 21	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
Change of Health related Quality of Life Time Frame: Day 1 and Day 21	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
Change of Fatigue Time Frame: Day 1 and Day 21	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
Change of Anxiety/Depression Time Frame: Day 1 and Day 21	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
Change of Sleeping Quality Time Frame: Day 1 and Day 21	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schön Klinik Berchtesgadener Land

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 29, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Frailty pre-LTX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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