Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis (Rehab-IPF)
Primary Purpose
Breathlessness, Quality of Life, Idiopathic Pulmonary Fibrosis
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Structured Responsive Exercise Training
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Breathlessness focused on measuring Idiopathic Pulmonary Fibrosis, Exercise training, Health related quality of life, Biomarkers
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.
Sites / Locations
- University Hospital Southampton
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Structured Responsive Exercise Training
Standard of Care Arm
Arm Description
8 week twice weekly supervised structured responsive static-cycle based exercise training. Training protocol used the same as Loughney et al. 2016
Completion of outcome measures only
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change from baseline in St. George's Respiratory Questionnaire -IPF (SGRQ-I)
Validated health and quality of life questionnaire for patients with IPF
Change from baseline in Medical Research Council (MRC) Breathlessness Scale
Validated breathlessness questionnaire for respiratory patients
Change from baseline in Revised Borg Breathlessness Score
Validated breathlessness score for respiratory patients
Change from baseline in 6 - Minute Walk Test Distance
Validated exercise capacity assessment for respiratory patients (meters)
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)
Change from baseline in Fat Mass Index (FMI)
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Change from baseline in Phase Angle measured by
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Change from baseline in Fat Free Mass Index (FFMI)
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Change from baseline in Skeletal Muscle Mass (kg)
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Change from baseline in Body Mass Index (kg/m2)
weight (kg)/height (m)2.
Change from baseline in Council of Nutrition Appetite Questionnaire (CNAQ)
A validated nutritional assessment tool. CNAQ Total Score 8-40 (40 better outcome)
Change from baseline in Simplified nutritional appetite questionnaire (SNAQ) questionnaire
A validated nutritional assessment tool. SNAQ 5-20 (20 better outcome)
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)
Full Information
NCT ID
NCT03222648
First Posted
June 23, 2017
Last Updated
May 23, 2022
Sponsor
University Hospital Southampton NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03222648
Brief Title
Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis
Acronym
Rehab-IPF
Official Title
Investigating the Effects of a Structured Responsive Exercise Training Programme in Idiopathic Pulmonary Fibrosis - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Southampton NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathlessness, Quality of Life, Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic Pulmonary Fibrosis, Exercise training, Health related quality of life, Biomarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single cohort pilot study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Structured Responsive Exercise Training
Arm Type
Experimental
Arm Description
8 week twice weekly supervised structured responsive static-cycle based exercise training. Training protocol used the same as Loughney et al. 2016
Arm Title
Standard of Care Arm
Arm Type
Active Comparator
Arm Description
Completion of outcome measures only
Intervention Type
Other
Intervention Name(s)
Structured Responsive Exercise Training
Intervention Description
Twice weekly, 8 week structured responsive exercise training programme. Protocol used the same as that used in previous EMPOWER Trial (Loughney et al. 2016)
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Continuation of usual care
Primary Outcome Measure Information:
Title
Change from baseline in endurance time on fixed load cycle
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in St. George's Respiratory Questionnaire -IPF (SGRQ-I)
Description
Validated health and quality of life questionnaire for patients with IPF
Time Frame
8 weeks
Title
Change from baseline in Medical Research Council (MRC) Breathlessness Scale
Description
Validated breathlessness questionnaire for respiratory patients
Time Frame
8 weeks
Title
Change from baseline in Revised Borg Breathlessness Score
Description
Validated breathlessness score for respiratory patients
Time Frame
8 weeks
Title
Change from baseline in 6 - Minute Walk Test Distance
Description
Validated exercise capacity assessment for respiratory patients (meters)
Time Frame
8 weeks
Title
Change from baseline Cardiopulmonary Exercise Test variables
Description
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
Title
Change from baseline in Fat Mass Index (FMI)
Description
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Time Frame
8 weeks
Title
Change from baseline in Phase Angle measured by
Description
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Time Frame
8 weeks
Title
Change from baseline in Fat Free Mass Index (FFMI)
Description
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Time Frame
8 weeks
Title
Change from baseline in Skeletal Muscle Mass (kg)
Description
measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.
Time Frame
8 weeks
Title
Change from baseline in Body Mass Index (kg/m2)
Description
weight (kg)/height (m)2.
Time Frame
8 weeks
Title
Change from baseline in Council of Nutrition Appetite Questionnaire (CNAQ)
Description
A validated nutritional assessment tool. CNAQ Total Score 8-40 (40 better outcome)
Time Frame
8 weeks
Title
Change from baseline in Simplified nutritional appetite questionnaire (SNAQ) questionnaire
Description
A validated nutritional assessment tool. SNAQ 5-20 (20 better outcome)
Time Frame
8 weeks
Title
Change from baseline in EQ-5D-5L
Description
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
Other Pre-specified Outcome Measures:
Title
Change from baseline in Blood biomarkers of disease activity in Idiopathic Pulmonary Fibrosis
Description
Plasma/Serum biomarkers including but not limited to Surfactant protein D, Periostin, Matrix Metalloproteinase-7 (MMP-7) and collagen neoepitopes.
Time Frame
8 weeks
Title
Change from baseline in Blood markers of oxidative stress
Description
Plasma markers of oxidative stress including but not limited to 15-F2t-isoprostanes
Time Frame
8 weeks
Title
Change from baseline in serum albumin
Description
Blood markers of systemic inflammation
Time Frame
8 weeks
Title
Change from baseline in serum C-Reactive Protein
Description
Blood markers of systemic inflammation
Time Frame
8 weeks
Title
Change from baseline in serum Interleukin-8
Description
Blood markers of systemic inflammation
Time Frame
8 weeks
Title
Change from baseline in total white blood cell count
Description
Blood markers of systemic inflammation
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim JM Wallis, MA BM MRCP
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Southampton
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26762365
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.
Results Reference
background
PubMed Identifier
20935110
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.
Results Reference
background
PubMed Identifier
25284270
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.
Results Reference
background
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Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis
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