Clinical trial · Interventional
Resistance Inspiratory Muscle Training for Patients With Thoracic Malignancies
The Effect of Resistance Inspiratory Muscle Training in the Management of Breathlessness in Patients With Thoracic Malignancies: A Randomized Controlled Trial
NCT03834116CI-TRIAL-00060508completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasm Malignant | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inspiratory muscle training | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Inspiratory muscle training group
- description
- A pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics.
- interventionNames
- Device: Inspiratory muscle training
- type
- NO_INTERVENTION
- label
- Control group
- description
- The control group will receive standard treatment in a fast-track design.
Primary outcomes (1)
- measure
- Modified Borg Scale (mBorg)
- timeFrame
- week 8
- description
- It is a vertical 0-10 scale, with corresponding verbal expressions of progressively increased intensity from "nothing at all" to ''maximal."
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (9)
- BACKGROUNDBarton 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. PMID 20392515
- BACKGROUNDMolassiotis 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. PMID 25417042
- BACKGROUNDFarquhar 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. PMID 19583857
- BACKGROUNDButland 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. PMID 6805625
- BACKGROUNDTan 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. PMID 27720789
- BACKGROUNDWilcock 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. PMID 10400541
- BACKGROUNDXu 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.