Effects of Continuous Chest Wall Vibration on Dyspnea and Exercise Tolerance in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of exercise tolerance
研究概览
简要总结
Dyspnea, the sensation of breathing discomfort or shortness of breath, is one of the main symptoms for patients affected by Chronic Obstructive Pulmonary Disease (COPD), particularly during exercise. Previous study show that chest wall vibration decrease dyspnea in COPD patients and precisely when applied during the inspiration phase, called "in-phase vibration" (IPV) which provide vibration directly on intercostal muscles. These findings have been obtained in laboratory context and the intercostals muscles vibration has been tested only in single phases of breathing, during inspiration with IPV and during exhalation with out-of-phase vibration (OPV). None study has evaluated the effect of a continuous chest wall vibration (CCWV), namely muscles vibration during the whole cycle of breathing, on dyspnea in patients with COPD in a clinical context. Continuous high frequency vibration has been proven to reduce myoelectrical manifestation of fatigue, probably modifying the centrally driven motor unit recruitment hierarchy, in healthy subjects.
Moreover, CCWV is a modality of provide vibration more suitable and cost-effective in a clinical context than single-phases vibration that requires specific instruments for the detection of breathing phases and the coupling with vibration device.
On these bases, the investigators hypothesized that CCWV at high frequency, applied during a cycle ergometer training program, could decrease dyspnea and enhance the exercise tolerance in COPD patients. Therefore, the aim of this study is to evaluate the effects of high frequency CCWV on dyspnea and exercise tolerance in patients with COPD patients compared to usual care and to sham intervention.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis (GOLD stage: 2-3-4)
排除标准
- •Restrictive lung disease
- •Active pulmonary infection
- •Pulmonary embolism (less than 3 months)
- •Pneumotorax
- •Thoracic/abdominal operation (less than 3 months)
- •Myocardial infarction (less than 6 months)
- •Congestive heart failure/ heart failure/ right heart failure
- •Angina/severe angina
- •Incapability of perform the cycle ergometer training (e.g. orthopaedic or urogenital conditions)
- •Incapability to understand the intructions required to carry out the tests and assessments planned
研究组 & 干预措施
Control group
Cycle ergometer training program: 2 minutes warm-up at no load, 20 minutes at 60% of peak work (PW) calculated by stress-test or at 50% of PW calculated according to Luxton equation (PW = 103.217 + (30.50 X gender) + (-1.613 X age) + (0.002 X 6MWW [m kg -1 ]). The progression of the workloads is calculated according to the BORG Dyspnea and Fatigue Scale (Borg D and F < 5: 10W increase; Borg D and/or F between 5 e 6: maintain same workload; Borg D and / or > 6: 10W decrease) Patient tailored airway clearance program guided by an experienced respiratory physical therapist, which could includes active cycle of breathing technique (ACBT), forced expiratory technique (FET), ELTGOL (slow expiration with glottis open in the lateral position) and PEP techniques (positive expiratory pressure).
干预措施: Cycle ergometer training (Other)
Control group
Cycle ergometer training program: 2 minutes warm-up at no load, 20 minutes at 60% of peak work (PW) calculated by stress-test or at 50% of PW calculated according to Luxton equation (PW = 103.217 + (30.50 X gender) + (-1.613 X age) + (0.002 X 6MWW [m kg -1 ]). The progression of the workloads is calculated according to the BORG Dyspnea and Fatigue Scale (Borg D and F < 5: 10W increase; Borg D and/or F between 5 e 6: maintain same workload; Borg D and / or > 6: 10W decrease) Patient tailored airway clearance program guided by an experienced respiratory physical therapist, which could includes active cycle of breathing technique (ACBT), forced expiratory technique (FET), ELTGOL (slow expiration with glottis open in the lateral position) and PEP techniques (positive expiratory pressure).
干预措施: Airway clearance program (Other)
Experimental group
Cycle ergometer training program plus application of vibration therapy. The vibration is provided at 150Hz via 4 effectors applied bilaterally at the second or third interspaces in the parasternal region of the upper chest wall and at the seventh to ninth interspaces anterior to the midaxillary line in the lower chest wall.
干预措施: Cycle ergometer training (Other)
Experimental group
Cycle ergometer training program plus application of vibration therapy. The vibration is provided at 150Hz via 4 effectors applied bilaterally at the second or third interspaces in the parasternal region of the upper chest wall and at the seventh to ninth interspaces anterior to the midaxillary line in the lower chest wall.
干预措施: Airway clearance program (Other)
Experimental group
Cycle ergometer training program plus application of vibration therapy. The vibration is provided at 150Hz via 4 effectors applied bilaterally at the second or third interspaces in the parasternal region of the upper chest wall and at the seventh to ninth interspaces anterior to the midaxillary line in the lower chest wall.
干预措施: Vibration therapy (Device)
Sham intervention group
Cycle ergometer training program plus application of sham vibration therapy: 4 effectors on chest-wall at same position of vibration therapy, the device that produces vibration is switched on, producing the typical noise and vibration is emitted by effectors not placed on the patient but left in place on the device.
干预措施: Cycle ergometer training (Other)
Sham intervention group
Cycle ergometer training program plus application of sham vibration therapy: 4 effectors on chest-wall at same position of vibration therapy, the device that produces vibration is switched on, producing the typical noise and vibration is emitted by effectors not placed on the patient but left in place on the device.
干预措施: Airway clearance program (Other)
Sham intervention group
Cycle ergometer training program plus application of sham vibration therapy: 4 effectors on chest-wall at same position of vibration therapy, the device that produces vibration is switched on, producing the typical noise and vibration is emitted by effectors not placed on the patient but left in place on the device.
干预措施: Sham vibration therapy (Device)
结局指标
主要结局
Change of exercise tolerance
时间窗: Change from Baseline exercise tolerance at 4 weeks
Six Minutes Walking Test. This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. Higher values represent a better outcome
Change of Dyspnea
时间窗: Change from Baseline Barthel Index based on dyspnea at 4 weeks
Barthel Index based on dyspnea. The scale measures the level of dyspnea perceived in performing basic daily living activities, Range: 0 - 100 Higher values represent a worse outcome
次要结局
- Change of Risk of death(Change from Baseline risk of death at 4 weeks)
- Change of Sympatho-vagal balance(Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks)
- Change of respiratory muscles strength(Change from Baseline respiratory muscles strength at 4 weeks)
- Change of Health-related quality of life(Change from Baseline health-related quality at 4 weeks)
研究者
Riccardo Buraschi
Principal Investigator
Fondazione Don Carlo Gnocchi Onlus