Compare the Effects of Preoperative Pulmonary Rehabilitation Exercises on Postoperative Anxiety and Muscle Strength

Comparison of the Effects of Preoperative Pulmonary Rehabilitation Exercises on Postoperative Anxiety and Muscle Strength in Lung Neoplasm Resection Patients

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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasm
• Intervention / Treatment: Other: Preoperative and postoperative pulmonary rehabilitation exercise; Other: Preoperative education and postoperative exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Zhongzheng District
    • Taipei, Zhongzheng District, Taiwan, 100
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative & postoperative exercise; Will receive preoperative thoracic surgery health education manuals. Tailored preoperative pulmonary rehabilitation exercises and postoperative regular pulmonary rehabilitation exercises.	Other: Preoperative and postoperative pulmonary rehabilitation exercise; Besides receiving preoperative thoracic surgery health education manuals and postoperative regular pulmonary rehabilitation exercises, they also receive exercises originally tailored for pulmonary rehabilitation, including upper-body resistance exercise, lower-body resistance exercise, aerobic exercise, and respiratory muscle training for 4-7 days before surgery. In addition, a communication app group will be set up and an exercise diary will be provided.
Active Comparator: Postoperative exercise; Preoperatively, an education manual was provided; postoperatively, routine rehabilitation exercises were given.	Other: Preoperative education and postoperative exercise; Receiving preoperative thoracic surgery health education manual and postoperative regular pulmonary rehabilitation exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Lung function	Lung function will be assessed using MicroLab Spirometer.; Forced Vital Capacity；FVC (L)、(% predicted); Forced Expiratory Volume in First Second；FEV1)(L) 、(% predicted); Peak Expiratory Flow Rate；PERF(L/S)、(% predicted); 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; 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; Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 202207101RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No