Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis

NCT03222648 | Completed DMC

• 1 other identifier: RHM MED1441
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Breathlessness; Quality of Life; Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; Exercise training; Health related quality of life; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change from baseline in St. George's Respiratory Questionnaire -IPF (SGRQ-I)

  8 weeks

• Change from baseline in Medical Research Council (MRC) Breathlessness Scale

  8 weeks

• Change from baseline in Revised Borg Breathlessness Score

  8 weeks

• Change from baseline in 6 - Minute Walk Test Distance

  8 weeks

• Change from baseline Cardiopulmonary Exercise Test variables

  8 weeks

Other Outcomes (6)

• Change from baseline in Blood biomarkers of disease activity in Idiopathic Pulmonary Fibrosis

  8 weeks

• Change from baseline in Blood markers of oxidative stress

  8 weeks

• Change from baseline in serum albumin

  8 weeks

Study Arms (2)

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

Other: Structured Responsive Exercise Training

Standard of Care Arm

ACTIVE COMPARATOR

Completion of outcome measures only

Other: Usual Care

Interventions

Structured Responsive Exercise Training OTHER

Twice weekly, 8 week structured responsive exercise training programme. Protocol used the same as that used in previous EMPOWER Trial (Loughney et al. 2016)

Structured Responsive Exercise Training

Usual Care OTHER

Continuation of usual care

Standard of Care Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 26762365 BACKGROUND

• 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.

  PMID: 20935110 BACKGROUND

• 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.

  PMID: 25284270 BACKGROUND

MeSH Terms

Conditions

Dyspnea; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases

Study Officials

• Tim JM Wallis, MA BM MRCP

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: single cohort pilot study

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: July 19, 2017
• Study Start: September 22, 2017
• Primary Completion: April 1, 2021
• Study Completion: August 8, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)