Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000026376
• Date of registration: 03/03/2017
• Prospective Registration: Yes
• Primary sponsor: Central Japan Lung Study Grou
• Public title: Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis
• Scientific title: Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis - Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in IPF
• Date of first enrolment: 2017/09/01
• Target sample size: 84
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030312
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Phase IV

Countries of recruitment

Japan

Contacts

• Name: Kensuke Kataoka
• Affiliation: Tosei General Hospital Respiratory Medicine and Allergy

• Name: Ryo Kozu
• Affiliation: Nagasaki University Institute of Biomedical Sciences

Key inclusion & exclusion criteria

Inclusion 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.

Age minimum: 40years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Idiopathic pulmonary fibrosis(IPF)

Intervention(s)

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

Primary Outcome(s)

Change from baseline in 6 minute walk distance (6MWD) (m) after 12 months of treatment

Secondary Outcome(s)

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

Secondary ID(s)

No.605

17082106

Source(s) of Monetary Support

Nipponn Boehringer Ingelheim CO ., Ltd.

Ethics review

Status: YES
Approval date: 22/08/2017
Contact:

[e-mail]

Tosei General Hospital IRB

[phone]

[e-mail]

Results

• Results available: Yes
• Date Completed: 31/12/2020