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

Completed

• Conditions: Advanced Lung Disease; COPD; Interstitial Lung Disease

• Registration Number: NCT04184180
• Lead Sponsor: Klaus Kenn

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.

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 Timeline

• Study First Submitted: 2019-10-23
• Study Start: 2019-12-02
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-03
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Effect of Frailty on Six-Minute-Walking-Test (6MWT)	Day 1 and Day 21	Frailty measured by Short physical Performance battery (SPPB)
Effect of Frailty on Timed-Up-an-Go-Test	Day 1 and Day 21	Frailty measured by Short physical Performance battery (SPPB)
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.
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
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"
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"
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
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
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
Effect of Frailty on Quadriceps-Force	Day 1 and Day 21	Frailty measured by SPPB

Trial Locations

Locations (1)

Schön Klinik Berchtesgadener Land; 🇩🇪 Schönau Am Königssee, Germany