Idiopathic pulmonary fibrosis(IPF)
Conditions
Interventions
Short-term induction pulmonary rehabilitation (2/1w for the first 12w) + Maintenance pulmonary rehabilitation and outpatient visit (1/4w) Total 52w. / No intervention
Nintedanib / both group
Sponsors
Central Japan Lung Study Grou
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients aged 40 =< and < 80 years at informed consent 2)Patient with IPF diagnosed according to the diagnosis criteria of INPULSIS trial and 2011 IPF guideline 3)200m=<6MWD of the past=<600m 4)Patient with dyspnoea on exercise (1=<mMRC=<3) 5)Stable patients without any infection nor acute exacerbation within 3 months 6)Patients who are already receiving Nintedanib at least 4 weeks prior to participating the study and expected to be able to take nintedanib for more than 12 months in this study 7)Patients who can visit hospital for the first twice a week, and every 2-4 weeks for follow 40 weeks to take outpatient rehabilitation program. 8)Patients who can comply with the instructed exercise and record it in diary. 9)Patients who can adequately answer to the PRO(QOL) questionnaire 10)%FVC>=50%, 79%>=%DLco>=30% 11)Written informed consent is obtained
Exclusion criteria
Exclusion criteria: 1)Patients with connective tissue disease, known neuromuscular disease or other orthopedic problem which may affect to exercise assessment, other disease requires exercise limitation 2)Patients who received pulmonary rehabilitation within 12 months 3)Patients with oral corticosteroids >15mg/day (prednisolone equivalent) or immunosuppressive agents within 3 months 4)Patients with pirfenidone within 3 months 5)Patients with unstable angina, a history of myocardial infarction or received percutaneous transluminal coronary angioplasty or coronary-artery bypass surgery within 1 month or a history of a cerebrovascular disease within 6 months. 6)Patients who requires antiarrhythmic therapy 7)Patients with serious pulmonary hypertension 8)ALT or AST > 2x upper limit of normal 9)Total bilirubin > 2x upper limit of normal 10)Creatinine clearance < 30mL/min 11)Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin) or high dose antiplatelet therapy. 12)Pregnant women and women of possibly pregnant. 13)Patients who cannot be evaluated by 6 minute walk test for any reason. 14)Other patients who are judged by the investigator as not adequate to participate in the study. 15)History of malignant disease within 3 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in 6 minute walk distance (6MWD) (m) after 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary endpoints: Change from baseline in endurance time in cycle ergometer after 12 months of treatment Other secondary endpoints: Following endpoints will be assessed after 12 months. 1)Change from baseline in SGRQ total score 2)Relative change from baseline (%) in 6MWD 3)Physical activity (triaxial accelerometer), health status (SGRQ domain scores and CAT score), dyspnoea (TDI, dyspnoea-12), HADS 4)FVC, DLCO, PaO2, SpO2 (at rest and after 6MWD test) 5)Rate of mortality and rate of unscheduled hospitalization 6)In addition to the assessment of 12 months, change from baseline in 6 minute walk distance (m) and all secondary endpoints will be assessed after 6 months of treatment. 7)Compliance to planed long term rehabilitation (ratio: actual/plan) in nintedanib + rehabilitation group 8)Percentage of patients whose compliance are >= 70% (good compliant patients) in the nintedanib + rehabilitation group 9)Change from baseline (m) in 6 minute walk distance in good compliant patients | — |
Countries
Japan
Contacts
Public ContactKensuke Kataoka
Tosei General Hospital Respiratory Medicine and Allergy
Outcome results
None listed