Clinical trial NCT06542055: Compare the Effects of Preoperative Pulmonary Rehabilitation Exercises on Postoperative Anxiety and Muscle Strength
Official title: Comparison of the Effects of Preoperative Pulmonary Rehabilitation Exercises on Postoperative Anxiety and Muscle Strength in Lung Neoplasm Resection Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasm
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: After confirming that the patient is eligible to participate and the patient signs a consent, basic information and The Hospital Anxiety and Depression Scale (HADS) will be completed at the preoperative clinic, and lung function tests, 30-second 30 seconds sit-to-stand test, grip strength test, physical status assessment, and activity level assessment will be performed. A healthcare instruction manual will be given at the preoperative clinic.

The preoperative exercise group (experimental group) and the control group will be assigned randomly. The preoperative exercise experiment group must complete the related exercises and records. The exercises include upper extremity resistance exercise, lower extremity resistance exercise, aerobic exercise, and respiratory muscle training.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing thoracic surgery with pulmonary resection (including wedge resection, segmentectomy, and lobectomy).
2. FEV1≦80%.
3. over 20 years old.
4. Those who can cooperate with pulmonary rehabilitation and sign the consent form.

Exclusion Criteria:

* Suspected metastases to other organs.
* Unsteady gait, limited mobility, unable to cooperate with exercise training
* Those who cannot communicate in Mandarin or Taiwanese.
* Oxygen saturation ≦85% at rest and without oxygen.
* New York Heart Association (NYHA) defines heart failure as grade IV.
* FEV1\<30% and ever diagnosed COPD patients.
* S/P pneumonectomy patient.

Primary outcomes:
measure: Anxiety and depression
timeFrame: at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)
Secondary outcomes:
measure: Lung function
timeFrame: 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
measure: Early Activity Level
timeFrame: 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)
measure: Grip strength
timeFrame: at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)
measure: Lower limb muscle strength
timeFrame: Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.Time Frame at baseline(preoperative OPD).
measure: Physical condition
timeFrame: 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
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng District
Study officials:
References: