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NCT Number: NCT04184180

Effects of Inpatient Pulmonary Rehabilitation 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.

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Key information

Conditions

Advanced Lung Disease COPD Chronic Disease Disease Attributes Frailty Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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

    Time frame: Day 1 and Day 21

    Frailty measured by Short physical Performance battery (SPPB)

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

    Time frame: Day 1 and Day 21

    Frailty measured by Short physical Performance battery (SPPB)

  4. Effect of Frailty on Quadriceps-Force

    Time frame: 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

    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.

  6. 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"

  7. 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"

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Klaus Kenn

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2019
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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