Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis

  • STATUS
    Recruiting
  • End date
    Feb 26, 2022
  • participants needed
    34
  • sponsor
    University Hospital Southampton NHS Foundation Trust
Updated on 26 October 2021
pneumonia
dyspnea
pulmonary disease
idiopathic pulmonary fibrosis
interstitial lung disease
hypersensitivity pneumonitis

Summary

In this single centre non-randomised pilot cohort study we wish to quantify the effect of a twice weekly, 8 week, structured responsive exercise training programme on exercise tolerance, symptoms and health related quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). We also wish to assess the effect of exercise training on fibrotic processes causing IPF through measurement of blood biomarkers of disease activity.

Description

Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease characterised by progressive exercise intolerance and breathlessness. In 2012 there were 32 500 people living in the United Kingdom (UK) with IPF. Average life expectancy from time of diagnosis is 2-3 years (Ley et al. 2011). Despite recent advances in drug therapy, therapeutic options are limited and no medication has been found to halt progression of the disease. Pulmonary Rehabilitation (PR) is a structured exercise and education intervention that is well established as a core treatment intervention for patients with Chronic Obstructive Pulmonary Disease (COPD). Current limited evidence shows that PR is safe in patients with IPF and can lead to short-term improvements in exercise tolerance, symptoms and quality of life (Dowman et al. 2014). However the optimal exercise protocol, the longer-term benefits and which group or patients (those with milder or more severe disease) benefit most is unclear. Further it is unknown what mechanisms underlie any improvement and whether exercise training influences the fibrotic process causing IPF.

Details
Condition Dyspnea, Pulmonary Fibrosis, Quality of life, Idiopathic Pulmonary Fibrosis, breathlessness, shortness of breath, breathing difficulty, difficulty breathing, breathless, trouble breathing, respiratory difficulties, breathing difficulties, quality-of-life, usual interstitial pneumonia
Treatment Usual Care, Structured Responsive Exercise Training
Clinical Study IdentifierNCT03222648
SponsorUniversity Hospital Southampton NHS Foundation Trust
Last Modified on26 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants aged 18-85 years with a confirmed diagnosis of fibrotic interstitial lung disease (fILD) including; Usual Interstitial Pneumonia, fibrotic Nonspecific interstitial pneumonia (NSIP), Chronic hypersensitivity pneumonitis (chronic HP) and unclassifiable interstitial lung disease (unclassified ILD). Medical Research Council (MRC) breathlessness scale grade 1-3. Clinically stable for 3 months as judged by investigator

Exclusion Criteria

Forced Expiratory Volume in 1 second (FEV1) to Forced Vital Capacity (FVC) FEV1/FVC ratio <0.7
Patients with severe heart failure New York Heart Association (NYHA) grade III or IV or left ventricular systolic function <45%
Current use of ambulatory or long term oxygen therapy
Resting oxygen saturations <85% on air
The presence of infection or exacerbation requiring hospitalization, within 3 months prior to recruitment
Commencement on anti-fibrotic therapy (Pirfenidone or Nintedanib) within 3 months prior to recruitment to the study
Patients taking oral corticosteroids: unless the dose is less than 15 mg of prednisolone or equivalent, and the dose has been stable for 8 weeks at the time of booking
Neoplastic disease undergoing treatment or active follow-up
Current or previous history of sarcoidosis or collagen vascular disease
Any condition which would prevent completion of cycle-ergometer testing, Pulmonary Function Tests (PFTs) or 6 minute walk test (6-MWT) as judged by the investigator
Participation in a Pulmonary Rehabilitation (PR) program in the last 6 months
Any condition excluding Cardiopulmonary Exercise Testing (CPET) based on the absolute contraindication as the American College of Chest Physicians (ACCP)/ American Thoracic Society (ATS) guidelines 2003 listed here: History of exercise induced syncope, Uncontrolled arrhythmia causing symptoms or hemodynamic compromise, Syncope, Acute endocarditis, Acute myocarditis or pericarditis, Symptomatic severe aortic stenosis, Uncontrolled heart failure, History of acute venous thrombo-embolism, Suspected dissecting aneurysm, uncontrolled asthma, Pulmonary oedema, Mental impairment leading in ability to cooperate, Room air desaturation to <85% unless supplemental O2 is provided for exercise, Acute non-cardiopulmonary disorder that may affect exercise performance/ aggravated by exercise
Positive Pregnancy test in females of childbearing age
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