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Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years - 85 Years
Gender
All
More Inclusion & Exclusion 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
N/A
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
University Hospital Southampton NHS Foundation Trust
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Tim JM Wallis, MA BM MRCP
Principal Investigator Affiliation
University Hospital Southampton NHS Foundation Trust
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Other
Overall Status
Recruiting
Countries
United Kingdom
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Breathlessness, Quality of Life, Idiopathic Pulmonary Fibrosis
Additional Details
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.
Arms & Interventions
Arms
Experimental: Structured Responsive Exercise Training
8 week twice weekly supervised structured responsive static-cycle based exercise training. Training protocol used the same as Loughney et al. 2016
Active Comparator: Standard of Care Arm
Completion of outcome measures only
Interventions
Other: - Structured Responsive Exercise Training
Twice weekly, 8 week structured responsive exercise training programme. Protocol used the same as that used in previous EMPOWER Trial (Loughney et al. 2016)
Other: - Usual Care
Continuation of usual care
Contact a Trial Team
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International Sites
University Hospital Southampton, Southampton, Hampshire, United Kingdom