Single-Center Intelligent Pulmonary Rehabilitation After Lung Cancer Surgery

Sponsor
Jianxing He
Study ID
NCT07631533
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Intelligent Pulmonary Function Exercise Device — DEVICE
    A digital pulmonary rehabilitation device used for active inspiratory and expiratory respiratory training. The device records the number of completed training sessions, expiratory and inspiratory repetitions, training parameters, target completion, reminders, and interruptions. Training data are synchronized to the study platform for adherence monitoring and remote follow-up.
  • Usual Care and Natural Recovery — BEHAVIORAL
    Usual perioperative care includes standard postoperative nursing, analgesia, coughing and sputum clearance instruction, early mobilization, wound and drainage tube management, discharge education, and routine follow-up. No structured pulmonary rehabilitation program assigned by the study team will be provided to the control group.

Study Details

This study will compare an intelligent pulmonary function exercise device with usual care and natural recovery in patients recovering from lung cancer surgery. After lung cancer surgery, many patients have reduced lung function, shortness of breath, lower exercise tolerance, and a risk of postoperative pulmonary complications. Standard care usually includes postoperative nursing, pain control, coughing and sputum clearance instruction, early mobilization, discharge education, and routine follow-up. However, patients often lack structured guidance, feedback, and monitoring after discharge. Participants in this study will be randomly assigned to one of two groups. One group will use an intelligent pulmonary function exercise device for respiratory training during hospitalization and at home until 30 days after surgery. The prescribed training is two sessions per day, with each session including 30 expiratory training repetitions and 30 inspiratory training repetitions. The device records training completion and related training information and provides reminders and feedback. The other group will receive usual perioperative care, standard discharge education, and natural recovery follow-up without a study-specified respiratory training device or training prescription. The main purpose of the study is to determine whether the intelligent pulmonary function exercise device improves recovery of forced expiratory volume in 1 second, or FEV1, from before surgery to 30 days after surgery. The study will also evaluate lung function at 90 days, symptoms, quality of life, walking capacity, training adherence, and postoperative complications.

Key Dates

First listed
Jun 8, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intelligent Pulmonary Function Exercise Device Group
  • Active Comparator: Usual Care and Natural Recovery Group

Primary Outcome Measure

Change in Forced Expiratory Volume in 1 Second From Baseline to 30 Days After Surgery [ Time Frame: Baseline and 30 days after surgery ]

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