Effects of Inpatient Pulmonary Rehabilitation on Frailty in Patients After

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04184180
Study type	Observational
Source	Schön Klinik Berchtesgadener Land
Contact
Status	Completed
Phase
Start date	December 2, 2019
Completion date	March 16, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06000696` - Healthy at Home Pilot
Active, not recruiting	`NCT03927820` - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)	N/A
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Completed	`NCT04105075` - COPD in Obese Patients
Recruiting	`NCT05825261` - Exploring Novel Biomarkers for Emphysema Detection
Active, not recruiting	`NCT04075331` - Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial	Phase 2/Phase 3
Terminated	`NCT03640260` - Respiratory Regulation With Biofeedback in COPD	N/A
Recruiting	`NCT04872309` - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Recruiting	`NCT05145894` - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Withdrawn	`NCT04210050` - Sleep Ventilation for Patients With Advanced Hypercapnic COPD	N/A
Terminated	`NCT03284203` - Feasibility of At-Home Handheld Spirometry	N/A
Recruiting	`NCT06110403` - Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness	Phase 1/Phase 2
Active, not recruiting	`NCT06040424` - Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients	Phase 3
Recruiting	`NCT05865184` - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Recruiting	`NCT04868357` - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program	N/A
Completed	`NCT01892566` - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV	N/A
Completed	`NCT04119856` - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD	N/A
Completed	`NCT04485741` - Strados System at Center of Excellence
Completed	`NCT03626519` - Effects of Menthol on Dyspnoea in COPD Patients	N/A
Recruiting	`NCT04860375` - Multidisciplinary Management of Severe COPD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms