The Effect of Resistance Inspiratory Muscle Training in the Management of Breathlessness in Patients With Thoracic Malignancies: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Modified Borg Scale (mBorg)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Modified Borg Scale (mBorg)
时间窗: week 8
It is a vertical 0-10 scale, with corresponding verbal expressions of progressively increased intensity from "nothing at all" to ''maximal."
次要结局
- Dyspnea Symptoms and Its Impact on Patients' Functional Status (Dyspnea-12 Questionnaire).(Week 12)
- Perceived Severity of Breathlessness(week 12)
- Anxiety and depression(week 12)
- Modified Borg scale(week 12.)
- 6-minute walk test (6MWT)(week 12)
- St George's Respiratory Questionnaire(week 12)
- Patients Compliance to IMT Protocol(Week 12.)
研究者
Professor Alex MOLASIOTIS
Chair Professor of Nursing and Head
The Hong Kong Polytechnic University