Clinical trial NCT03222648: Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis
Official title: Investigating the Effects of a Structured Responsive Exercise Training Programme in Idiopathic Pulmonary Fibrosis - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathlessness
Quality of Life
Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
Exercise training
Health related quality of life
Biomarkers
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single cohort pilot study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in endurance time on fixed load cycle
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in St. George's Respiratory Questionnaire -IPF (SGRQ-I)
timeFrame: 8 weeks
measure: Change from baseline in Medical Research Council (MRC) Breathlessness Scale
timeFrame: 8 weeks
measure: Change from baseline in Revised Borg Breathlessness Score
timeFrame: 8 weeks
measure: Change from baseline in 6 - Minute Walk Test Distance
timeFrame: 8 weeks
measure: Change from baseline Cardiopulmonary Exercise Test variables
timeFrame: 8 weeks
measure: Change from baseline in Fat Mass Index (FMI)
timeFrame: 8 weeks
measure: Change from baseline in Phase Angle measured by
timeFrame: 8 weeks
measure: Change from baseline in Fat Free Mass Index (FFMI)
timeFrame: 8 weeks
measure: Change from baseline in Skeletal Muscle Mass (kg)
timeFrame: 8 weeks
measure: Change from baseline in Body Mass Index (kg/m2)
timeFrame: 8 weeks
measure: Change from baseline in Council of Nutrition Appetite Questionnaire (CNAQ)
timeFrame: 8 weeks
measure: Change from baseline in Simplified nutritional appetite questionnaire (SNAQ) questionnaire
timeFrame: 8 weeks
measure: Change from baseline in EQ-5D-5L
timeFrame: 8 Weeks
Other outcomes:
measure: Change from baseline in Blood biomarkers of disease activity in Idiopathic Pulmonary Fibrosis
timeFrame: 8 weeks
measure: Change from baseline in Blood markers of oxidative stress
timeFrame: 8 weeks
measure: Change from baseline in serum albumin
timeFrame: 8 weeks
measure: Change from baseline in serum C-Reactive Protein
timeFrame: 8 weeks
measure: Change from baseline in serum Interleukin-8
timeFrame: 8 weeks
measure: Change from baseline in total white blood cell count
timeFrame: 8 weeks
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Tim JM Wallis, MA BM MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loughney L, West MA, Kemp GJ, Rossiter HB, Burke SM, Cox T, Barben CP, Mythen MG, Calverley P, Palmer DH, Grocott MP, Jack S. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients (The EMPOWER Trial): study protocol for a randomised controlled trial. Trials. 2016 Jan 13;17:24. doi: 10.1186/s13063-015-1149-4.
citation: Ley B, Collard HR, King TE Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):431-40. doi: 10.1164/rccm.201006-0894CI. Epub 2010 Oct 8.
citation: Dowman L, Hill CJ, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2014 Oct 6;(10):CD006322. doi: 10.1002/14651858.CD006322.pub3.