Respiratory Muscle Performance and Functional Capacity in Primary Stage IIIb and IV Lung Cancer
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Lung Cancer |
| Study Type: | Observational |
| Study Design: | 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 |
- 1-year respiratory morbidity rate and 1-year mortality rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom [ Time Frame: 1-2 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Lung cancer
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with primary stage IIIb and IV lung cancer
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)
Contacts and Locations| Contact: Chung-Chun Lai, MS. | 886-2-23123456 ext 66515 | r95428009@ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Chung-Chun Lai, MS. 886-23123456 ext 66515 r95428009@ntu.edu.tw | |
| Principal Investigator: | Chung-Chun Lai, MS. | Physical Thaerapy Center, National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | Chung-Chun Lai, Physical Therapy Center, National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01078883 History of Changes |
| Other Study ID Numbers: | 20090805R |
| Study First Received: | February 28, 2010 |
| Last Updated: | January 6, 2011 |
| Health Authority: | Taiwan: Department of Health |
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 |
ClinicalTrials.gov processed this record on May 16, 2013