Respiratory Muscle Performance and Functional Capacity in Primary Stage IIIb and IV Lung Cancer

• Conditions: Lung Cancer

• Registration Number: NCT01078883
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The purpose of our study is to investigate the association between respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory morbidity rate, and 1-year mortality in patients with primary stage IIIb and IV lung cancer.

Detailed Description

Background and Purpose: Respiratory muscle function is important in sustaining the levels of physical activity required for daily life. The purpose of our study is to investigate the association between respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory morbidity rate, and 1-year mortality in patients with primary stage IIIb and IV lung cancer.

Methods: A total of 120 patients with newly diagnosed primary stage IIIb and IV lung cancer will be recruited from the National Taiwan University Hospital. Demographic and clinical signs/syndromes will be obtained from the chart. Pain and dyspnea will be measured using visual analog scale. Respiratory muscle strength will be tested by measuring maximal inspiratory and expiratory pressure (PImax and PEmax, respectively). Spirometric variables, forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) will be measured. Functional capacity will be measured using Karnofsky performance status and Simmonds functional assessment. Anxiety/depression symptom will be measured using Hospital Anxiety and Depression Scale. One year respiratory complication morbidity and 1-year mortality will be recorded in prospective nature. Spearman's and Pearson correlation coefficient will be used to test the relationship between respiratory muscle performance and multiple variables. Univariate and stepwise multiple regression analyses will be used to identify factors associated with respiratory muscle performance, functional capacity, one-year respiratory morbidity and one-year mortality rate in patients with primary stage IIIb and IV lung cancer.

Clinical relevance: The prevalence of lung cancer is increasing in the recent years. The attempt to understand the relations between respiratory muscle performance, functional capacity and associated clinical courses will shed light on whether chest physical therapy intervention will be beneficial for patients with primary IIIb and IV lung cancer.

Study Timeline

• Study First Submitted: 2010-02-28
• Study Start: 2010-03
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Status Verified: 2010-12
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-10
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Clinical diagnosis of stage IIIb/V lung cancer
• Normal cognition (a Mini Mental State Examination score of more than/equal to 24 points)
• Able to finish all tests

Read More

Exclusion Criteria

• A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. acute pneumonia)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-year respiratory morbidity rate and 1-year mortality rate	1 year

Secondary Outcome Measures

Name	Time	Method
respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom	1-2 days

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan