Compare the Effects of Preoperative Pulmonary Rehabilitation Exercises on Postoperative Anxiety and Muscle Strength
NCT Number: NCT06542055
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Neoplasm
Interventions: OTHER: Preoperative and postoperative pulmonary rehabilitation exercise|OTHER: Preoperative education and postoperative exercise
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-02-17
Completion Date: 2024-07-30
Locations: National Taiwan University Hospital, Taipei, Zhongzheng District, 100, Taiwan

Summary:
Lung cancer, tracheal and bronchial cancers have long been the leading cause of cancer mortality in Taiwan. According to statistics, about 40% of newly diagnosed lung cancers are treated with surgery as the primary treatment. Although early surgery improves survival rates, most patients experience significant decreases in lung function, and physical function after surgery, which affects their quality of life.

Recent studies have found that preoperative and postoperative lung rehabilitation exercises play an increasingly important role in lung cancer care. In Taiwan, postoperative interventions for lung cancer have shown significant benefits, but there is a lack of evidence on the effectiveness of preoperative rehabilitation programs. To understand the effectiveness of the preoperative pulmonary rehabilitation program, a preoperative home rehabilitation program was designed to compare the efficacy of preoperative pulmonary rehabilitation in the current lung cancer care of patients undergoing lung neoplasm surgery.

Primary Outcome Measures: Anxiety and depression, The patient's anxiety was assessed by the Hospital Anxiety and Depression Scale (HADS).

The scale consists of 14 items, with 7 items for anxiety and 7 items for depression. The anxiety items are the odd-numbered questions, and the depression items are the even-numbered questions. Each item is scored on a four-point scale (0-3 points). The scores for the two subscales are calculated separately, each with a total score ranging from 0 to 21. Higher scores indicate greater levels of anxiety or depression., at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)
Secondary Outcome Measures: Lung function, Lung function will be assessed using MicroLab Spirometer.

1. Forced Vital Capacity；FVC (L)、(% predicted)
2. Forced Expiratory Volume in First Second；FEV1)(L) 、(% predicted)
3. Peak Expiratory Flow Rate；PERF(L/S)、(% predicted)
4. FEV1/FVC(%), Through preoperative intervention, rehabilitation exercises for the lungs were performed for up to 6 weeks after surgery until discharge. The time frame includes at baseline (preoperative outpatient department)、at admission and before discharge|Early Activity Level, ICCA (IntelliSpace Critical Care and Anesthesia) Ranges from 0-10, the higher level indicates better functional activity., Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.The initial activity level after surgery (through study completion, an average of 3 weeks)|Grip strength, measured with TTM-YD digital grip strength dynamometer, at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)|Lower limb muscle strength, 30 seconds sit and stand test, Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.Time Frame at baseline(preoperative OPD).|Physical condition, ECOG Performance Status Scale 0 Fully active, able to carry on all pre-disease performance without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
5. Dead, Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.Time Frame at baseline(preoperative OPD)、the next day after surgery