Respiratory Muscle Performance and Functional Capacity in Primary Stage IIIb and IV Lung Cancer
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Lung cancer, Respiratory muscle strength, Dyspnea, Functional capacity
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: 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

Exclusion Criteria:

- A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. acute pneumonia)
Location
National Taiwan University Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Chung-Chun Lai, MS. - 886-23123456 - r95428009@ntu.edu.tw
Start Date
March 2010
Completion Date
March 2011
Sponsors
National Taiwan University Hospital
Source
National Taiwan University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page