Resistance Inspiratory Muscle Training for Patients With Thoracic Malignancies

Lung Neoplasm Malignant Clinical Trial

Official title:

The Effect of Resistance Inspiratory Muscle Training in the Management of Breathlessness in Patients With Thoracic Malignancies: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834116
• Other study ID #: HSEARS20180509003
• Status: Completed
• Phase: N/A
• Start date: November 23, 2019
• Est. completion date: September 15, 2021

Study information

• Verified date: August 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Hence, the aim of this study is to assess the effectiveness of IMT in patients with thoracic malignancies on dyspnea.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm Malignant
• Lung Neoplasms
• Neoplasms

Intervention

Device:
• Inspiratory muscle training
A pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics.

Locations

Country	Name	City	State
China	Southwest Medical University Hospital	Luzhou

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The Affiliated Hospital Of Southwest Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wilcock A, Crosby V, Clarke D, Tattersfield A. Repeatability of breathlessness measurements in cancer patients. Thorax. 1999 Apr;54(4):375. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	week 8
Secondary	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	week 8
Secondary	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	week 12
Secondary	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	Week 8
Secondary	Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).	D-12 questionnaire uses 12 items.	Week 12
Secondary	Perceived Severity of Breathlessness	Will be measured on a 0-10 numerical rating scale (NRS)	week 8
Secondary	Perceived Severity of Breathlessness	Will be measured on a 0-10 numerical rating scale (NRS)	week 12
Secondary	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.	week 8
Secondary	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.	week 12
Secondary	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.	week 8
Secondary	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.	week 12
Secondary	Modified Borg scale	It is a vertical 0-10 scale, with corresponding verbal expressions of progressively increased intensity from "nothing at all" to ''maximal."	week 12.
Secondary	Patients Compliance to IMT Protocol	Each patient in the experimental arm will be given a training diary to record IMT home practice sessions.	Week 12.