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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Twice weekly, 8 week structured responsive exercise training programme. Protocol used the same as that used in previous EMPOWER Trial (Loughney et al. 2016)
Continuation of usual care
University Hospital Southampton
Southampton, Hampshire, United Kingdom
Change from baseline in endurance time on fixed load cycle
validated fixed load static cycling test at 75% peak oxygen consumption (VO2 peak) derived from derived from cardiopulmonary exercise testing (CPET) (seconds)
Time frame: 8 weeks
Change from baseline in St. George's Respiratory Questionnaire -IPF (SGRQ-I)
Validated health and quality of life questionnaire for patients with IPF
Time frame: 8 weeks
Change from baseline in Medical Research Council (MRC) Breathlessness Scale
Validated breathlessness questionnaire for respiratory patients
Time frame: 8 weeks
Change from baseline in Revised Borg Breathlessness Score
Validated breathlessness score for respiratory patients
Time frame: 8 weeks
Change from baseline in 6 - Minute Walk Test Distance
Validated exercise capacity assessment for respiratory patients (meters)
Time frame: 8 weeks
Change from baseline Cardiopulmonary Exercise Test variables
A validated tool for access multiple parameters of exercise capacity measures including but not limited to; peak Oxygen consumption ml/kg/minute (VO2 peak), anaerobic threshold ml/kg/minute (AT) , volume of oxygen work rate relationship ml/watt (VO2/Work Rate)
Time frame: 8 weeks
Change from baseline in Fat Mass Index (FMI)
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
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Time frame: 8 weeks
Change from baseline in Phase Angle measured by
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Time frame: 8 weeks
Change from baseline in Fat Free Mass Index (FFMI)
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Time frame: 8 weeks
Change from baseline in Skeletal Muscle Mass (kg)
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Time frame: 8 weeks
Change from baseline in Body Mass Index (kg/m2)
weight (kg)/height (m)2.
Time frame: 8 weeks
Change from baseline in Council of Nutrition Appetite Questionnaire (CNAQ)
A validated nutritional assessment tool. CNAQ Total Score 8-40 (40 better outcome)
Time frame: 8 weeks
Change from baseline in Simplified nutritional appetite questionnaire (SNAQ) questionnaire
A validated nutritional assessment tool. SNAQ 5-20 (20 better outcome)
Time frame: 8 weeks
Change from baseline in EQ-5D-5L
A validated global health related quality of life PROM. Total Score, Subsections (Mobility, Self-Care, Usual Activity, Pain/Discomfort, Anxiety/Depression. Visual Analogue Scale (0-100)
Time frame: 8 Weeks