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

NCT ID: NCT01078883

Last Updated: 2011-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-03-31

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lung cancer

Patients with primary stage IIIb and IV lung cancer

No interventions assigned to this group

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Physical Therapy Center, National Taiwan University Hospital

Principal Investigators

Chung-Chun Lai, MS.

Role: PRINCIPAL_INVESTIGATOR

Physical Thaerapy Center, National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chung-Chun Lai, MS.

Role: CONTACT

r95428009@ntu.edu.tw

886-2-23123456 ext. 66515

Facility Contacts

Chung-Chun Lai, MS.

Role: primary

r95428009@ntu.edu.tw

886-23123456 ext. 66515

Other Identifiers

20090805R

Identifier Type: -

Identifier Source: org_study_id