BreathlessnessRehab-IPFNCT03222648
Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis
A study testing Structured Responsive Exercise Training in people with Breathlessness and Quality of Life, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breathlessness, Quality of Life, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Structured Responsive Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2017to 8 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
About this study
Official title: Investigating the Effects of a Structured Responsive Exercise Training Programme in Idiopathic Pulmonary Fibrosis - a Pilot Study
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.
Read the 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.
- Being tested
- Structured Responsive Exercise Training, Usual Care
- Keywords
- Idiopathic Pulmonary Fibrosis, Exercise training, Health related quality of life, Biomarkers
- Medical subject headings
- Dyspnea, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Responsive Exercise TrainingOther
Twice weekly, 8 week structured responsive exercise training programme. Protocol used the same as that used in previous EMPOWER Trial (Loughney et al. 2016)
Usual CareOther
Continuation of usual care
| Study group | Role | What they receive |
|---|---|---|
| Structured Responsive Exercise Training | Experimental | 8 week twice weekly supervised structured responsive static-cycle based exercise training. Training protocol used the same as Loughney et al. 2016 Receives: Other: Structured Responsive Exercise Training |
| Standard of Care Arm | Active comparator | Completion of outcome measures only Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Secondary outcomes (13)
Change from baseline in St. George's Respiratory Questionnaire -IPF (SGRQ-I)
Validated health and quality of life questionnaire for patients with IPF
Measured: 8 weeks
Change from baseline in Medical Research Council (MRC) Breathlessness Scale
Validated breathlessness questionnaire for respiratory patients
Measured: 8 weeks
Change from baseline in Revised Borg Breathlessness Score
Validated breathlessness score for respiratory patients
Measured: 8 weeks
Change from baseline in 6 - Minute Walk Test Distance
Validated exercise capacity assessment for respiratory patients (meters)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Change from baseline in Body Mass Index (kg/m2)
weight (kg)/height (m)2.
Measured: 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)
Measured: 8 weeks
Change from baseline in Simplified nutritional appetite questionnaire (SNAQ) questionnaire
A validated nutritional assessment tool. SNAQ 5-20 (20 better outcome)
Measured: 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)
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start22 Sep 2017
- Primary completion1 Apr 2021
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BreathlessnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- single cohort pilot study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Wallis, University Hospital Southampton NHS Foundation Trust
- Investigators
- Tim JM Wallis, MA BM MRCP, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222648
- Sponsor's protocol ID
- RHM MED1441
- Acronym
- Rehab-IPF
- Status last verified
- May 2024
- First submitted
- 23 Jun 2017
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26762365Ley 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.
PubMed 20935110Dowman 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.
PubMed 25284270
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of a Structured Responsive Exercise Training Programme in Idiopathic Pulmonary Fibrosis - a Pilot Study
- ClinicalTrials.gov ID
- NCT03222648
- Acronym / sponsor ID
- Rehab-IPF / RHM MED1441
- Keywords
- Idiopathic Pulmonary Fibrosis, Exercise training, Health related quality of life, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single cohort pilot study
| Arm | Type | Receives |
|---|---|---|
| Structured Responsive Exercise Training | Experimental | Other: Structured Responsive Exercise Training8 week twice weekly supervised structured responsive static-cycle based exercise training. Training protocol used the same as Loughney et al. 2016 |
| Standard of Care Arm | Active comparator | Other: Usual CareCompletion of outcome measures only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Responsive Exercise TrainingTwice weekly, 8 week structured responsive exercise training programme. Protocol used the same as that used in previous EMPOWER Trial (Loughney et al. 2016) | Other | Structured Responsive Exercise Training |
| Usual CareContinuation of usual care | Other | Standard of Care Arm |
Primary outcome
Change from baseline in endurance time on fixed load cycle
Time frame: 8 weeks
validated fixed load static cycling test at 75% peak oxygen consumption (VO2 peak) derived from derived from cardiopulmonary exercise testing (CPET) (seconds)
13 secondary outcomes
Change from baseline in St. George's Respiratory Questionnaire -IPF (SGRQ-I)
Time frame: 8 weeks
Change from baseline in Medical Research Council (MRC) Breathlessness Scale
Time frame: 8 weeks
Change from baseline in Revised Borg Breathlessness Score
Time frame: 8 weeks
Change from baseline in 6 - Minute Walk Test Distance
Time frame: 8 weeks
Change from baseline Cardiopulmonary Exercise Test variables
Time frame: 8 weeks
Change from baseline in Fat Mass Index (FMI)
Time frame: 8 weeks
Change from baseline in Phase Angle measured by
Time frame: 8 weeks
Change from baseline in Fat Free Mass Index (FFMI)
Time frame: 8 weeks
Change from baseline in Skeletal Muscle Mass (kg)
Time frame: 8 weeks
Change from baseline in Body Mass Index (kg/m2)
Time frame: 8 weeks
Change from baseline in Council of Nutrition Appetite Questionnaire (CNAQ)
Time frame: 8 weeks
Change from baseline in Simplified nutritional appetite questionnaire (SNAQ) questionnaire
Time frame: 8 weeks
Change from baseline in EQ-5D-5L
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 26762365Loughney 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.
- Background: PubMed 20935110Ley 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.
- Background: PubMed 25284270Dowman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim JM Wallis, MA BM MRCP principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Responsive Exercise Training in people with Breathlessness and Quality of Life, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in endurance time on fixed load cycle (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03222648, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.