Clinical trial NCT03834116: Resistance Inspiratory Muscle Training for Patients With Thoracic Malignancies
Official title: The Effect of Resistance Inspiratory Muscle Training in the Management of Breathlessness in Patients With Thoracic Malignancies: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasm Malignant
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital Of Southwest Medical University
First posted: 2019-02-07
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Borg Scale (mBorg)
timeFrame: week 8
Secondary outcomes:
measure: 6-minute walk test (6MWT)
timeFrame: week 8
measure: 6-minute walk test (6MWT)
timeFrame: week 12
measure: Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).
timeFrame: Week 8
measure: Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).
timeFrame: Week 12
measure: Perceived Severity of Breathlessness
timeFrame: week 8
measure: Perceived Severity of Breathlessness
timeFrame: week 12
measure: St George's Respiratory Questionnaire
timeFrame: week 8
measure: St George's Respiratory Questionnaire
timeFrame: week 12
measure: Anxiety and depression
timeFrame: week 8
measure: Anxiety and depression
timeFrame: week 12
measure: Modified Borg scale
timeFrame: week 12.
measure: Patients Compliance to IMT Protocol
timeFrame: Week 12.
Other outcomes:
Locations:
city: Luzhou
country: China
facility: Southwest Medical University Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Alex Molassiotis
role: STUDY_CHAIR
References:
citation: 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.
citation: Molassiotis 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.
citation: Farquhar 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.
citation: Butland 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.
citation: Tan 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.
citation: Wilcock 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.
citation: Xu 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.
citation: Walker 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.