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Status unknownNCT01078883Updated Jan 10, 2011

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

An observational study in Lung Cancer, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2011-01-10.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Lung Cancer

Keywords

  • Lung cancer
  • Respiratory muscle strength
  • Dyspnea
  • Functional capacity
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In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's planned enrollment of 80 is below the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,608 studies on the registry; 573 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with primary stage IIIb and IV lung cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. acute pneumonia)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)

Groups and cohorts

  • Lung cancer

    Patients with primary stage IIIb and IV lung cancer

06

What researchers measure

Primary outcomes

  1. 1-year respiratory morbidity rate and 1-year mortality rate

    Time frame: 1 year

Secondary outcomes

  1. respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom

    Time frame: 1-2 days

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01078883
First posted
Mar 2, 2010
Start date
Mar 2010
Primary completion
Mar 2011 (estimated)
Completion
Mar 2011 (estimated)
Last update
Jan 10, 2011

Study contacts

Chung-Chun Lai, MS.
Contact
r95428009@ntu.edu.tw
886-2-23123456 ext. 66515
Chung-Chun Lai, MS.
principal investigator · Physical Thaerapy Center, National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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