RehaBoost trial

Phase 2

Recruiting

• Conditions: lung cancer patients with air flow limitation scheduled for surgical treatment

• Registration Number: JPRN-jRCTs042230112
• Lead Sponsor: Ohde Yasuhisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-30
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1) age>=18
2) ECOG performance status (PS) is 0, 1, or 2.
3) Primary lung cancer is suspected or diagnosed.
4) Surgical treatment is scheduled between 14 and 28 days after registration.
5) Anatomical lung resection is planned.
6) Pulmonary function tests are available.
7) FEV1% [FEV1/FVC] < 70% or the patient has already been diagnosed with chronic obstructive pulmonary disease (COPD).
8) Patients has no history of bronchial asthma.
9) Patients who possess a smart phones.
10) Main organ function other than the lungs is preserved, and the physician determines that general anesthesia is feasible.
11) The patient has given a full explanation of the study and obtained written consent prior to enrollment in the study.

Exclusion Criteria

1) Patients with synchronous or metachronous malignancies, including multiple lung cancers that are judged to require surgical treatment within six months at the time of enrollment (patients with multiple lung cancers that are scheduled for simultaneous resection or other malignancies that are judged to be completely resectable by endoscopic resection are not excluded.)Patients with synchronous or metachronous malignancies, including multiple lung cancers, scheduled for treatment at the time of enrollment (patients with only multiple lung cancers scheduled forsimultaneous resection are not excluded)
2) Patients with local infections requiring treatment or active systemic infections requiring treatment( Patients under observation only are not excluded)Persons with localized or systemically active infections requiring medical attention
3) Pregnant, lactating, or women who may be currently pregnant
4) Patients with a history of ischemic heart disease
5) Patients with a history of cerebrovascular disease (A history of transient ischemic attack is acceptable)
6) Patients with uncontrolled hypertension
7) Patients who are considered to have difficulty performing the six-minute walking test due to orthopedic conditions, or other reasons
8) Patients with clinically problematic psychiatric
disorders that would preclude enrollment in this study
9) Patients who use a pacemaker, implantable cardioverter-defibrillator, or other medical devices
that could be affected by magnetic materials
10) Patients with a history of hypersensitivity to silicon, rubber products, or metals
11) Patients with a history of serious hypersensitivity
12) Patients deemed inappropriate for registration by the physician in charge.

Study & Design

• Study Type: Interventional
• Study Design: Not specified