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

Association Between Respiratory Muscle Performance and Functional Capacity in Patients With Primary Stage IIIb & IV Lung Cancer

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Chung-Chun Lai, MS.; Phone Number: 66515 886-2-23123456; Email: r95428009@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chung-Chun Lai, MS.; Phone Number: 66515 886-23123456; Email: r95428009@ntu.edu.tw

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary stage IIIb and IV lung cancer

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Lung cancer; Patients with primary stage IIIb and IV lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1-year respiratory morbidity rate and 1-year mortality rate	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom	1-2 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chung-Chun Lai, MS., Physical Thaerapy Center, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): March 1, 2011
• Study Completion (Anticipated): March 1, 2011

Study Registration Dates

• First Submitted: February 28, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (Estimate): March 2, 2010

Study Record Updates

• Last Update Posted (Estimate): January 10, 2011
• Last Update Submitted That Met QC Criteria: January 6, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Lung cancer; Dyspnea; Functional capacity; Respiratory muscle strength
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 20090805R