Clinical trial NCT01078883: Respiratory Muscle Performance and Functional Capacity in Primary Stage IIIb and IV Lung Cancer
Official title: Association Between Respiratory Muscle Performance and Functional Capacity in Patients With Primary Stage IIIb & IV Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Lung cancer
Respiratory muscle strength
Dyspnea
Functional capacity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary stage IIIb and IV lung cancer

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.

Eligibility 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)

Primary outcomes:
measure: 1-year respiratory morbidity rate and 1-year mortality rate
timeFrame: 1 year
Secondary outcomes:
measure: respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom
timeFrame: 1-2 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Physical Thaerapy Center, National Taiwan University Hospital
name: Chung-Chun Lai, MS.
role: PRINCIPAL_INVESTIGATOR
References: