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

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ClinicalTrials.gov Identifier: NCT01078883
Recruitment Status : Unknown
Verified December 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 2, 2010
Last Update Posted : January 10, 2011
Sponsor:
Information provided by:
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.

Condition or disease
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
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Respiratory Muscle Performance and Functional Capacity in Patients With Primary Stage IIIb & IV Lung Cancer
Study Start Date : March 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 1-year respiratory morbidity rate and 1-year mortality rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom [ Time Frame: 1-2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary stage IIIb and IV lung cancer
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078883


Contacts
Contact: Chung-Chun Lai, MS. 886-2-23123456 ext 66515 r95428009@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chung-Chun Lai, MS.    886-23123456 ext 66515    r95428009@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chung-Chun Lai, MS. Physical Thaerapy Center, National Taiwan University Hospital

Responsible Party: Chung-Chun Lai, Physical Therapy Center, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01078883     History of Changes
Other Study ID Numbers: 20090805R
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: December 2010

Keywords provided by National Taiwan University Hospital:
Lung cancer
Respiratory muscle strength
Dyspnea
Functional capacity

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases