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

Sponsor
Klaus Kenn (Other)
Overall Status
Completed
CT.gov ID
NCT04184180
Collaborator
(none)
33
1
3.4
9.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    33 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effects of an Inpatient Pulmonary Rehabilitation Programme on Frailty in Patients After Lung-Transplantation
    Actual Study Start Date :
    Dec 2, 2019
    Actual Primary Completion Date :
    Mar 16, 2020
    Actual Study Completion Date :
    Mar 16, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Change of Frailty (SPPB) [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

    Secondary Outcome Measures

    1. Change of Frailty (FFP) [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

    2. Effect of Frailty on Six-Minute-Walking-Test (6MWT) [Day 1 and Day 21]

      Frailty measured by Short physical Performance battery (SPPB)

    3. Effect of Frailty on Timed-Up-an-Go-Test [Day 1 and Day 21]

      Frailty measured by Short physical Performance battery (SPPB)

    4. Effect of Frailty on Quadriceps-Force [Day 1 and Day 21]

      Frailty measured by SPPB

    5. Correlation between Frailty-Score (measured by Short physical Performance Battery (SPPB)) and attended exerecise sessions [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.

    6. Correlation between Cognitive Status measured by Montreal Cognitive Assessment (MOCA) and Frailty Score [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"

    7. Correlation between Cognitive Status measured by Addenbrooke's Cognitive Examination (ACE-R) and Frailty Score [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"

    8. Correlation between Social Support and Frailty Score [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

    9. Change of Health related Quality of Life: Chronic Respiratory Questionnaire (CRQ) [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

    10. Change of Fatigue [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

    11. Change of Anxiety/Depression [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

    12. Change of Sleeping Quality: Pittsburgh Sleep Quality Index (PSQI) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Schön Klinik Berchtesgadener Land Schönau Am Königssee Germany

    Sponsors and Collaborators

    • Klaus Kenn

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Klaus Kenn, Professor of pulmonary rehabilitation, Schön Klinik Berchtesgadener Land
    ClinicalTrials.gov Identifier:
    NCT04184180
    Other Study ID Numbers:
    • Frailty post-LTx
    First Posted:
    Dec 3, 2019
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Klaus Kenn, Professor of pulmonary rehabilitation, Schön Klinik Berchtesgadener Land
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 5, 2021