Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis

Quality of Life Clinical Trial

— Rehab-IPF  

Official title:

Investigating the Effects of a Structured Responsive Exercise Training Programme in Idiopathic Pulmonary Fibrosis - a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03222648
• Other study ID #: RHM MED1441
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: October 2022

Study information

• Verified date: May 2022
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). We also wish to assess the effect of exercise training on fibrotic processes causing IPF through measurement of blood biomarkers of disease activity.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: October 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breathlessness
• Dyspnea
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis
• Quality of Life

Intervention

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)
• Usual Care
Continuation of usual care

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. Review. Update in: Cochrane Database Syst Rev. 2021 Feb 1;2:CD006322. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in Blood biomarkers of disease activity in Idiopathic Pulmonary Fibrosis	Plasma/Serum biomarkers including but not limited to Surfactant protein D, Periostin, Matrix Metalloproteinase-7 (MMP-7) and collagen neoepitopes.	8 weeks
Other	Change from baseline in Blood markers of oxidative stress	Plasma markers of oxidative stress including but not limited to 15-F2t-isoprostanes	8 weeks
Other	Change from baseline in serum albumin	Blood markers of systemic inflammation	8 weeks
Other	Change from baseline in serum C-Reactive Protein	Blood markers of systemic inflammation	8 weeks
Other	Change from baseline in serum Interleukin-8	Blood markers of systemic inflammation	8 weeks
Other	Change from baseline in total white blood cell count	Blood markers of systemic inflammation	8 weeks
Primary	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)	8 weeks
Secondary	Change from baseline in St. George's Respiratory Questionnaire -IPF (SGRQ-I)	Validated health and quality of life questionnaire for patients with IPF	8 weeks
Secondary	Change from baseline in Medical Research Council (MRC) Breathlessness Scale	Validated breathlessness questionnaire for respiratory patients	8 weeks
Secondary	Change from baseline in Revised Borg Breathlessness Score	Validated breathlessness score for respiratory patients	8 weeks
Secondary	Change from baseline in 6 - Minute Walk Test Distance	Validated exercise capacity assessment for respiratory patients (meters)	8 weeks
Secondary	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)	8 weeks
Secondary	Change from baseline in Fat Mass Index (FMI)	measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.	8 weeks
Secondary	Change from baseline in Phase Angle measured by	measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.	8 weeks
Secondary	Change from baseline in Fat Free Mass Index (FFMI)	measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.	8 weeks
Secondary	Change from baseline in Skeletal Muscle Mass (kg)	measured by Bioelectrical Impedance Analysis a validated tool to access multiple parameters of body composition.	8 weeks
Secondary	Change from baseline in Body Mass Index (kg/m2)	weight (kg)/height (m)2.	8 weeks
Secondary	Change from baseline in Council of Nutrition Appetite Questionnaire (CNAQ)	A validated nutritional assessment tool. CNAQ Total Score 8-40 (40 better outcome)	8 weeks
Secondary	Change from baseline in Simplified nutritional appetite questionnaire (SNAQ) questionnaire	A validated nutritional assessment tool. SNAQ 5-20 (20 better outcome)	8 weeks
Secondary	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)	8 Weeks