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

NCT06542055 | Completed

• 1 other identifier: 202207101RINC
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Lung function

  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

  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

  at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)

• Lower limb muscle strength

  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

  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

Study Arms (2)

Preoperative & postoperative exercise

EXPERIMENTAL

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

Postoperative exercise

ACTIVE COMPARATOR

Preoperatively, an education manual was provided; postoperatively, routine rehabilitation exercises were given.

Other: Preoperative education and postoperative exercise

Interventions

Preoperative and postoperative pulmonary rehabilitation exercise OTHER

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.

Preoperative & postoperative exercise

Preoperative education and postoperative exercise OTHER

Receiving preoperative thoracic surgery health education manual and postoperative regular pulmonary rehabilitation exercises

Postoperative exercise

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: August 7, 2024
• Study Start: February 17, 2023
• Primary Completion: February 28, 2024
• Study Completion: July 30, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)