RehaBoost trial

JRCT ID: jRCTs042230112

Registered date:30/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: lung cancer patients with air flow limitation scheduled for surgical treatment
• Date of first enrollment: 04/03/2024
• Target sample size: 78
• Study type: Interventional

Intervention(s)

Preoperative telerehabilitation intervention: After enrollment, the Fitbit Inspire 3 will be placed on the wrist of the patients. A web interview will be conducted within 14 days of patient enrollment and as soon as possible prior to the day before surgery to begin the preoperative home-based intensive telerehabilitation instruction. The instruction will be provided to the subjects in video format. The content consists of aerobic exercise and strength training (including respiratory muscle training), and the appropriate amount of exercise load will be provided individually. The amount of load will be increased or decreased according to the implementation status.
Tele-rehabilitation instruction is not provided during the hospitalization.
Postoperative telerehabilitation intervention: The Fitbit Inspire 3 will be placed on the wrist of patients immediately after discharge from the hospital, and a web interview will be conducted between postoperative day 14 and 28 to begin postoperative home-based intensive telerehabilitation instruction. Postoperative intensive telerehabilitation instruction will continue until the 90th postoperative day.

Outcome(s)

• Primary Outcome: Six-minute walking distance (difference between preoperative and three months after surgery)

Secondary Outcome

Six-minute walking distance (difference between preoperative and six months after surgery)
Feasibility of Fitbit Inspire 3 (heart rate data acquisition rate)
QOL (CAT [COPD Assessment Test] (Japanese), EQ5D5L [EuroQol 5 dimensions 5-level] Japanese version)
PRO response collection rate
Postoperative complications
Postoperative respiratory function
Resting heart rate
Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ohde Yasuhisa
• Source(s) of Monetary Support: Takeda Science Foundation,COVIDIEN JAPAN INC.