Lung CancerNCT01078883
Respiratory Muscle Performance and Functional Capacity in Primary Stage IIIb and IV Lung Cancer
An observational study of Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary stage IIIb and IV lung cancer
Who may be able to join
- 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
Who cannot join
- A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. acute pneumonia)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chung-Chun Lai, MS., 886-23123456 ext. 66515, r95428009@ntu.edu.tw
About this study
Official title: 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.
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.
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Respiratory muscle strength, Dyspnea, Functional capacity
- Medical subject headings
- Lung Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Patients with primary stage IIIb and IV lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year respiratory morbidity rate and 1-year mortality rate
Measured: 1 year
Secondary outcomes (1)
respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chung-Chun Lai, MS., Principal investigator, Physical Thaerapy Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078883
- Sponsor's protocol ID
- 20090805R
- Status last verified
- Dec 2010
- First submitted
- 28 Feb 2010
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Respiratory Muscle Performance and Functional Capacity in Patients With Primary Stage IIIb & IV Lung Cancer
- ClinicalTrials.gov ID
- NCT01078883
- Acronym / sponsor ID
- 20090805R
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Respiratory muscle strength, Dyspnea, Functional capacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | –Patients with primary stage IIIb and IV lung cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary stage IIIb and IV lung cancer
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. acute pneumonia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-year respiratory morbidity rate and 1-year mortality rate
Time frame: 1 year
1 secondary outcome
respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom
Time frame: 1-2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Chun Lai, MS. principal investigator
Physical Thaerapy Center, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung-Chun Lai, MS. (886-2-23123456 ext. 66515, r95428009@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year respiratory morbidity rate and 1-year mortality rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.