Lung Neoplasm MalignantNCT03834116
Resistance Inspiratory Muscle Training for Patients With Thoracic Malignancies
A study testing Inspiratory muscle training in people with Lung Neoplasm Malignant, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
A small-scale pilot randomized controlled trial conducted by the investigators demonstrated some preliminary evidence that inspiratory muscle training (IMT) could be a promising self-management method for alleviating breathlessness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2019to 15 Sep 2021
- 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
- adults with histological diagnosis of primary LC or mesothelioma;
- refractory dyspnea not responding to current treatment for the past 2 weeks;
- expected prognosis of >3 months as judged by the clinicians,
- oxygen saturation above 85% at rest.
Who cannot join
- Those with unstable COPD with frequent or acute exacerbations,
- rapidly worsening dyspnea requiring urgent medical intervention,
- treatment with palliative radiotherapy to the chest received within 4 weeks or chemotherapy within 2 weeks;
- experiencing intractable cough, and those having unstable angina or clinically significant pleural effusion needing drainage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Resistance Inspiratory Muscle Training in the Management of Breathlessness in Patients With Thoracic Malignancies: A Randomized Controlled Trial
A small-scale pilot randomized controlled trial conducted by the investigators demonstrated some preliminary evidence that inspiratory muscle training (IMT) could be a promising self-management method for alleviating breathlessness. Hence, the aim of this study is to assess the effectiveness of IMT in patients with thoracic malignancies on dyspnea.
Read the detailed description
The hypothesis of this study is that inspiratory muscle training (IMT) for a three-month treatment will improve dyspnea in lung cancer patients with stable disease experiencing breathlessness.
Plan of Investigation Subjects The sample will be a heterogeneous group of outpatients cared for in a large university medical center in China (Southwest Medical University Hospital).
Methods The trial will be a two-arm, non-blinded, randomized controlled study. Patients will be randomly assigned through a computer program to IMT or a control group by an independent statistician. The IMT group will receive standard care and additionally the IMT intervention. The control group will receive standard treatment.
Study Design Intervention: A pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics. When patients inhale through the IMT device, the valve blocks air flow until the patient generates sufficient inspiratory pressure to overcome the resistance provided by the spring-loaded valve. The patient must generate the inspiratory pressure, in order for the valve to open and allow inhalation of air. The IMT protocol will have five sessions weekly for 12 weeks for 30 mins/day, divided over two sessions.
Procedures Participants will be recruited at the outpatients' clinic of Southwest Medical University Hospital or referred to the research team by the clinicians. Patients allocated to the experimental arm will have training in the IMT use and the trainer (device) will be adjusted to a level which is comfortable to each patient. In the control arm, patients will be visited for completing the study assessments at the same times as in the experimental arm (months 2 \& 3).
Sample Size The investigators have used the mBorg score change [primary outcome] in baseline to month three assessment of 0.80 obtained in the pilot study and the established minimally important difference of 1 for the mBorg to calculate sample size requirements, adding a 25% attrition observed in the pilot study. This corresponds to a sample size of 196 subjects.
Data Processing and Analysis The statistical software package IBM SPSS version 23.0 will be used. Descriptive statistics will summarize the sample characteristics. Generalized estimating equations (GEE) models will be used to compare differential changes in the outcomes between the two study arms across multiple time points (baseline-month 2 and month 3 assessment). A p-value of <0.05 was considered statistically significance. Intention-to-treat analysis will be carried out.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- Inspiratory muscle training
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
A pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training group | Experimental | A pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics. Receives: Device: Inspiratory muscle training |
| Control group | No intervention | The control group will receive standard treatment in a fast-track design. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Borg Scale (mBorg)
It is a vertical 0-10 scale, with corresponding verbal expressions of progressively increased intensity from "nothing at all" to ''maximal."
Measured: week 8
Secondary outcomes (12)
6-minute walk test (6MWT)
6-minute walk test (6MWT) on a level surface, which is easy for patients, well-validated, and correlates well with lung function
Measured: week 8
6-minute walk test (6MWT)
6-minute walk test (6MWT) on a level surface, which is easy for patients, well-validated, and correlates well with lung function
Measured: week 12
Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).
D-12 questionnaire uses 12 items, higher scores indicate more impact of dyspnea on functional status
Measured: Week 8
Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).
D-12 questionnaire uses 12 items.
Measured: Week 12
Perceived Severity of Breathlessness
Will be measured on a 0-10 numerical rating scale (NRS)
Measured: week 8
Perceived Severity of Breathlessness
Will be measured on a 0-10 numerical rating scale (NRS)
Measured: week 12
St George's Respiratory Questionnaire
The St George's Respiratory Questionnaire will be used. It measures impact on overall health, daily life, and perceived well-being in patients with dyspnea. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: week 8
St George's Respiratory Questionnaire
The St George's Respiratory Questionnaire will be used. It measures impact on overall health, daily life, and perceived well-being in patients with dyspnea. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: week 12
Anxiety and depression
The Hospital Anxiety \& Depression Scale will be used. It has 14 items, 7 measuring anxiety and 7 measuring depression, with higher scores indicating more anxiety or depression. For each subscale, scores more than 10 indicate clinical signs of anxiety or depression.
Measured: week 8
Anxiety and depression
The Hospital Anxiety \& Depression Scale will be used. It has 14 items, 7 measuring anxiety and 7 measuring depression, with higher scores indicating more anxiety or depression. For each subscale, scores more than 10 indicate clinical signs of anxiety or depression.
Measured: week 12
Modified Borg scale
It is a vertical 0-10 scale, with corresponding verbal expressions of progressively increased intensity from "nothing at all" to ''maximal."
Measured: week 12.
Patients Compliance to IMT Protocol
Each patient in the experimental arm will be given a training diary to record IMT home practice sessions.
Measured: Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start23 Nov 2019
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lung Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital Of Southwest Medical University
- Responsible party
- Principal investigator, Professor Alex MOLASIOTIS, The Hong Kong Polytechnic University
- Investigators
- Alex Molassiotis, Study chair, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834116
- Sponsor's protocol ID
- HSEARS20180509003
- Status last verified
- Aug 2022
- First submitted
- 1 Feb 2019
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barton R, English A, Nabb S, Rigby AS, Johnson MJ. A randomised trial of high vs low intensity training in breathing techniques for breathless patients with malignant lung disease: a feasibility study. Lung Cancer. 2010 Dec;70(3):313-9. doi: 10.1016/j.lungcan.2010.03.007. Epub 2010 Apr 14.
PubMed 20392515Molassiotis A, Charalambous A, Taylor P, Stamataki Z, Summers Y. The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a feasibility randomised trial. Support Care Cancer. 2015 Jun;23(6):1637-45. doi: 10.1007/s00520-014-2511-x. Epub 2014 Nov 23.
PubMed 25417042Farquhar MC, Higginson IJ, Fagan P, Booth S. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease. BMC Palliat Care. 2009 Jul 7;8:9. doi: 10.1186/1472-684X-8-9.
PubMed 19583857Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available.
PubMed 6805625Tan JY, Yorke J, Harle A, Smith J, Blackhall F, Pilling M, Molassiotis A. Assessment of Breathlessness in Lung Cancer: Psychometric Properties of the Dyspnea-12 Questionnaire. J Pain Symptom Manage. 2017 Feb;53(2):208-215. doi: 10.1016/j.jpainsymman.2016.08.009. Epub 2016 Oct 5.
PubMed 27720789Wilcock A, Crosby V, Clarke D, Tattersfield A. Repeatability of breathlessness measurements in cancer patients. Thorax. 1999 Apr;54(4):375. doi: 10.1136/thx.54.4.374b. No abstract available.
PubMed 10400541Xu W, Collet JP, Shapiro S, Lin Y, Yang T, Wang C, Bourbeau J. Validation and clinical interpretation of the St George's Respiratory Questionnaire among COPD patients, China. Int J Tuberc Lung Dis. 2009 Feb;13(2):181-9.
PubMed 19146745Walker J, Postma K, McHugh GS, Rush R, Coyle B, Strong V, Sharpe M. Performance of the Hospital Anxiety and Depression Scale as a screening tool for major depressive disorder in cancer patients. J Psychosom Res. 2007 Jul;63(1):83-91. doi: 10.1016/j.jpsychores.2007.01.009.
PubMed 17586341Li MY, Liu XL, Peng B, Wang T, Yao LQ, Huang HQ, Kwok WH, Tan JB, Molassiotis A. The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a randomised controlled trial. Support Care Cancer. 2025 May 22;33(6):492. doi: 10.1007/s00520-025-09511-9.
PubMed 40402333
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistance Inspiratory Muscle Training in the Management of Breathlessness in Patients With Thoracic Malignancies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03834116
- Acronym / sponsor ID
- HSEARS20180509003
- Conditions
- Lung Neoplasm Malignant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital Of Southwest Medical University
- Study start
- 23 Nov 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 7 Feb 2019 (actual)
- 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.
A small-scale pilot randomized controlled trial conducted by the investigators demonstrated some preliminary evidence that inspiratory muscle training (IMT) could be a promising self-management method for alleviating breathlessness. Hence, the aim of this study is to assess the effectiveness of IMT in patients with thoracic malignancies on dyspnea.
Detailed description
The hypothesis of this study is that inspiratory muscle training (IMT) for a three-month treatment will improve dyspnea in lung cancer patients with stable disease experiencing breathlessness.
Plan of Investigation Subjects The sample will be a heterogeneous group of outpatients cared for in a large university medical center in China (Southwest Medical University Hospital).
Methods The trial will be a two-arm, non-blinded, randomized controlled study. Patients will be randomly assigned through a computer program to IMT or a control group by an independent statistician. The IMT group will receive standard care and additionally the IMT intervention. The control group will receive standard treatment.
Study Design Intervention: A pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics. When patients inhale through the IMT device, the valve blocks air flow until the patient generates sufficient inspiratory pressure to overcome the resistance provided by the spring-loaded valve. The patient must generate the inspiratory pressure, in order for the valve to open and allow inhalation of air. The IMT protocol will have five sessions weekly for 12 weeks for 30 mins/day, divided over two sessions.
Procedures Participants will be recruited at the outpatients' clinic of Southwest Medical University Hospital or referred to the research team by the clinicians. Patients allocated to the experimental arm will have training in the IMT use and the trainer (device) will be adjusted to a level which is comfortable to each patient. In the control arm, patients will be visited for completing the study assessments at the same times as in the experimental arm (months 2 \& 3).
Sample Size The investigators have used the mBorg score change [primary outcome] in baseline to month three assessment of 0.80 obtained in the pilot study and the established minimally important difference of 1 for the mBorg to calculate sample size requirements, adding a 25% attrition observed in the pilot study. This corresponds to a sample size of 196 subjects.
Data Processing and Analysis The statistical software package IBM SPSS version 23.0 will be used. Descriptive statistics will summarize the sample characteristics. Generalized estimating equations (GEE) models will be used to compare differential changes in the outcomes between the two study arms across multiple time points (baseline-month 2 and month 3 assessment). A p-value of <0.05 was considered statistically significance. Intention-to-treat analysis will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training group | Experimental | Device: Inspiratory muscle trainingA pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics. |
| Control group | No intervention | –The control group will receive standard treatment in a fast-track design. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- adults with histological diagnosis of primary LC or mesothelioma;
- refractory dyspnea not responding to current treatment for the past 2 weeks;
- expected prognosis of >3 months as judged by the clinicians,
- oxygen saturation above 85% at rest.
Key exclusion criteria (4 listed)
- Those with unstable COPD with frequent or acute exacerbations,
- rapidly worsening dyspnea requiring urgent medical intervention,
- treatment with palliative radiotherapy to the chest received within 4 weeks or chemotherapy within 2 weeks;
- experiencing intractable cough, and those having unstable angina or clinically significant pleural effusion needing drainage
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 |
|---|---|---|
| Inspiratory muscle trainingA pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics. | Device | Inspiratory muscle training group |
Primary outcome
Modified Borg Scale (mBorg)
Time frame: week 8
It is a vertical 0-10 scale, with corresponding verbal expressions of progressively increased intensity from "nothing at all" to ''maximal."
12 secondary outcomes
6-minute walk test (6MWT)
Time frame: week 8
6-minute walk test (6MWT)
Time frame: week 12
Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).
Time frame: Week 8
Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).
Time frame: Week 12
Perceived Severity of Breathlessness
Time frame: week 8
Perceived Severity of Breathlessness
Time frame: week 12
St George's Respiratory Questionnaire
Time frame: week 8
St George's Respiratory Questionnaire
Time frame: week 12
Anxiety and depression
Time frame: week 8
Anxiety and depression
Time frame: week 12
Modified Borg scale
Time frame: week 12.
Patients Compliance to IMT Protocol
Time frame: Week 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 20392515Barton R, English A, Nabb S, Rigby AS, Johnson MJ. A randomised trial of high vs low intensity training in breathing techniques for breathless patients with malignant lung disease: a feasibility study. Lung Cancer. 2010 Dec;70(3):313-9. doi: 10.1016/j.lungcan.2010.03.007. Epub 2010 Apr 14.
- Background: PubMed 25417042Molassiotis A, Charalambous A, Taylor P, Stamataki Z, Summers Y. The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a feasibility randomised trial. Support Care Cancer. 2015 Jun;23(6):1637-45. doi: 10.1007/s00520-014-2511-x. Epub 2014 Nov 23.
- Background: PubMed 19583857Farquhar MC, Higginson IJ, Fagan P, Booth S. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease. BMC Palliat Care. 2009 Jul 7;8:9. doi: 10.1186/1472-684X-8-9.
- Background: PubMed 6805625Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available.
- Background: PubMed 27720789Tan JY, Yorke J, Harle A, Smith J, Blackhall F, Pilling M, Molassiotis A. Assessment of Breathlessness in Lung Cancer: Psychometric Properties of the Dyspnea-12 Questionnaire. J Pain Symptom Manage. 2017 Feb;53(2):208-215. doi: 10.1016/j.jpainsymman.2016.08.009. Epub 2016 Oct 5.
- Background: PubMed 10400541Wilcock A, Crosby V, Clarke D, Tattersfield A. Repeatability of breathlessness measurements in cancer patients. Thorax. 1999 Apr;54(4):375. doi: 10.1136/thx.54.4.374b. No abstract available.
- Background: PubMed 19146745Xu W, Collet JP, Shapiro S, Lin Y, Yang T, Wang C, Bourbeau J. Validation and clinical interpretation of the St George's Respiratory Questionnaire among COPD patients, China. Int J Tuberc Lung Dis. 2009 Feb;13(2):181-9.
- Background: PubMed 17586341Walker J, Postma K, McHugh GS, Rush R, Coyle B, Strong V, Sharpe M. Performance of the Hospital Anxiety and Depression Scale as a screening tool for major depressive disorder in cancer patients. J Psychosom Res. 2007 Jul;63(1):83-91. doi: 10.1016/j.jpsychores.2007.01.009.
- Derived from this study: PubMed 40402333Li MY, Liu XL, Peng B, Wang T, Yao LQ, Huang HQ, Kwok WH, Tan JB, Molassiotis A. The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: a randomised controlled trial. Support Care Cancer. 2025 May 22;33(6):492. doi: 10.1007/s00520-025-09511-9.
- Individual participant dataSharing planned: Undecided
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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.
Alex Molassiotis study chair
The Hong Kong Polytechnic 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 Inspiratory muscle training in people with Lung Neoplasm Malignant, run by The Hong Kong Polytechnic University at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 Aug 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Borg Scale (mBorg) (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834116, which also lists 9 linked publications.
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 23 Aug 2022.