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

November 4, 2021 updated by: Klaus Kenn

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

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.

Study Overview

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 (7-10).

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 (11-13). A recent prospective cohort study in the UK observed a significant decrease of frailty in patients with COPD participating at an inpatient rehabilitation program (5). Singer et al. (USA) could detect a significant decrease of frailty by a homebased training for LTx-candidates (6).

Aim of this study is to investigate the effects of a three-week inpatient rehabilitation program on physical frailty (measured by Short Physical Performance Battery) in patients after LTx. 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 30 participants is based on a sample size calculation. Assessments will take place in the beginning of rehabilitation program and at discharge.

Study Type

Observational

Enrollment (Actual)

33

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

      • Schönau Am Königssee, Germany
        • Schön Klinik Berchtesgadener Land

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

No

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

Exclusion Criteria:

  • Non compliance at assessments
  • Re-Transplantation

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
Day 1 and Day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Frailty on Quadriceps-Force
Time Frame: Day 1 and Day 21
Frailty measured by SPPB
Day 1 and 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 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 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
Day 1 and Day 21
Effect of Frailty on Six-Minute-Walking-Test (6MWT)
Time Frame: Day 1 and Day 21
Frailty measured by Short physical Performance battery (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 Short physical Performance battery (SPPB)
Day 1 and Day 21
Correlation between Frailty-Score (measured by Short physical Performance Battery (SPPB)) and attended exerecise sessions
Time Frame: Day 1 to Day 21
Frailty socre will be measured by the Short physical Performance battery (SPPB); attended exercise sessions (number) will be assessed within the pulmonary Rehabilitation Programme.
Day 1 to Day 21
Change of Health related Quality of Life: Chronic Respiratory Questionnaire (CRQ)
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 Sleeping Quality: Pittsburgh Sleep Quality Index (PSQI)
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

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 2, 2019

Primary Completion (Actual)

March 16, 2020

Study Completion (Actual)

March 16, 2020

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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