Lung CancerNCT01743586
Respiratory Muscle Function Changes and Effects of Chest Physiotherapy Education Interventionin Advanced Lung Cancer
A study testing Chest physiotherapy education intervention in people with Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Chest physiotherapy education intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Aug 2013
- Phase
- Interventional
- 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
Who may be able to join
- Clinical diagnosis of stage III/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. musculoskeletal disorders)
- Unable to perform acceptable-quality spirometry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Changes in Respiratory Muscle Function on Dyspnea, Functional Capacity, and Quality of Life in Patients With Advanced Lung Cancer & the Effects of Chest Physiotherapy Education Intervention
The purpose for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). The 2nd phase of this study will investigate the potential beneficial effects of chest physiotherapy in the same patient population (intervention group).
Read the detailed description
Respiratory muscle function is critical for maintaining effective alveolar ventilation, and airway secretions clearance. The reduction in respiratory muscle function might lead to chronic respiratory insufficiency, and potentially to life-threatening problems. Respiratory muscle function and the impacts of various treatments regimens have not been investigated longitudinally in patients with advanced lung cancer patients.
The purposes for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). The 2nd phase of this study will investigate the potential beneficial effects of chest physiotherapy in the same patient population (intervention group).
Methods: 102 patients with advanced lung cancer per group 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. Quality of life will be measured using European Organization for Research and Treatment of Cancer, EORTC QLQ-C30 and LC13 questionnaire. Six- and 12-month respiratory complication morbidity and survival status will be recorded in the prospective nature.
Clinical relevance: The prevalence of lung cancer is increasing in the recent years. To understand the indications for chest physiotherapy (e.g., respiratory muscle weakness and its related sequels) and the effects of chest physiotherapy program will shed light on if routine chest physiotherapy should be implanted for patients with advanced lung cancer during treatment.
- Conditions
- Lung Cancer
- Being tested
- Chest physiotherapy education intervention
- Keywords
- Lung cancer, Chest physiotherapy, Respiratory muscle strength, Dyspnea, Functional capacity, Quality of life
- 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.
Chest physiotherapy education interventionOther
breathing exercise (diaphragmatic breathing and pursed-lip breathing cough training secretion mobilization (percussion and vibration) progressive muscle relaxation pacing and energy-saving techniques
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described Receives: Other: Chest physiotherapy education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of upper respiratory infections (URI) and respiratory infection related hospitalizations
Numbers of URIs and respiratory infection related hospitalizations were collected from out-patient and inpatient medical records.
Measured: 12 months after study entry
Secondary outcomes (2)
Funcional capacity Anxiety/depression symptom Quality of life Six- and 12-month respiratory complication morbidity and survival status
Functional capacity measures included six-minute walk test, 50-foot walk with preferred and fast speed, and Barthel Index
Measured: every 3 months up to 18 months post study entry
Dyspnea and QoL
Dyspnea was assessed using modified Borg scale and QoL was assessed using EORTC QLQ-C30 and LC13 questionnaires.
Measured: every 3 months up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startAug 2010
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Li-Ying Wang, Ph.D., Principal investigator, School and Graduate Institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743586
- Sponsor's protocol ID
- 200912088R
- Status last verified
- Nov 2012
- First submitted
- 16 Mar 2010
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Changes in Respiratory Muscle Function on Dyspnea, Functional Capacity, and Quality of Life in Patients With Advanced Lung Cancer & the Effects of Chest Physiotherapy Education Intervention
- ClinicalTrials.gov ID
- NCT01743586
- Acronym / sponsor ID
- 200912088R
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Chest physiotherapy, Respiratory muscle strength, Dyspnea, Functional capacity, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 6 Dec 2012 (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 for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). The 2nd phase of this study will investigate the potential beneficial effects of chest physiotherapy in the same patient population (intervention group).
Detailed description
Respiratory muscle function is critical for maintaining effective alveolar ventilation, and airway secretions clearance. The reduction in respiratory muscle function might lead to chronic respiratory insufficiency, and potentially to life-threatening problems. Respiratory muscle function and the impacts of various treatments regimens have not been investigated longitudinally in patients with advanced lung cancer patients.
The purposes for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). The 2nd phase of this study will investigate the potential beneficial effects of chest physiotherapy in the same patient population (intervention group).
Methods: 102 patients with advanced lung cancer per group 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. Quality of life will be measured using European Organization for Research and Treatment of Cancer, EORTC QLQ-C30 and LC13 questionnaire. Six- and 12-month respiratory complication morbidity and survival status will be recorded in the prospective nature.
Clinical relevance: The prevalence of lung cancer is increasing in the recent years. To understand the indications for chest physiotherapy (e.g., respiratory muscle weakness and its related sequels) and the effects of chest physiotherapy program will shed light on if routine chest physiotherapy should be implanted for patients with advanced lung cancer during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | Other: Chest physiotherapy education intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of stage III/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 (2 listed)
- A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. musculoskeletal disorders)
- Unable to perform acceptable-quality spirometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest physiotherapy education interventionbreathing exercise (diaphragmatic breathing and pursed-lip breathing cough training secretion mobilization (percussion and vibration) progressive muscle relaxation pacing and energy-saving techniques | Other | Control |
Primary outcome
Numbers of upper respiratory infections (URI) and respiratory infection related hospitalizations
Time frame: 12 months after study entry
Numbers of URIs and respiratory infection related hospitalizations were collected from out-patient and inpatient medical records.
2 secondary outcomes
Funcional capacity Anxiety/depression symptom Quality of life Six- and 12-month respiratory complication morbidity and survival status
Time frame: every 3 months up to 18 months post study entry
Dyspnea and QoL
Time frame: every 3 months up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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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.
Li-Ying Wang, Ph.D. principal investigator
School and Graduate Institute of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy education intervention in people with 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 2 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 6 Dec 2012. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of upper respiratory infections (URI) and respiratory infection related hospitalizations (time frame: 12 months after study entry). 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 6 Dec 2012.