The Effects of Acu-TENS in the Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Baseline dyspnea evaluated with Baseline Dyspnea Index (BDI)
研究概览
简要总结
Dyspnoea is one of the most important determinants of quality of life and often limits the activities of daily life, in subjects suffering from moderate-to-severe chronic obstructive pulmonary disease (COPD). Pharmachological treatment of dyspnoea is affected by several side effects and, in long-lasting treatments, a reduction of clinical efficacy may occur. Previous studies showed a reduction of perceived dyspnoea after trials of acupuncture or Transcutaneous Electrical Nerve Stimulation over acupoints (Acu-TENS).
In this study will be investigated the effect of Acu-TENS on lung function and dyspnoea in patients with moderate-to-severe COPD (Cronic Obstructive Pulmonary Disease).
详细描述
Aim of the study is to verify the effectiveness of treatment with Acu-TENS to reduce perceived dyspnoea in patients suffering from moderate-to severe COPD. Secondary aims are to investigate the effects of the above treatments on quality of life, exercise capacity, pulmonary lung function.
Thirty consecutive patients, admitted to Auxilium Vitae Rehabilitation Centre for intensive pulmonary rehabilitation (PR) programme, suffering from moderate-to-severe COPD, will be enrolled. Subjects will be randomly assigned to two groups with different treatments (n=15 group 1: experimental subjects - PR+Acu-TENS and n=15 group 2: control subjects - PR only) by sequential block randomization.
An intensive inpatient PR programme will be applied to all participants. The programme will include the optimisation of drug therapy and daily sessions of:
- Supervised incremental exercises on a treadmill, a cycle,and an arm ergometer according to the protocol suggested by Maltais et al. until the achievement of 30 min of continuous exercise at an intensity that elicited dyspnoea at level 5 on a modified Borg scale starting from a workload corresponding to 50% of maximal workload achieved during an initial incremental test;
- Abdominal, upper- and lower-limb muscle activities involving lifting of progressively increasing light weight and shoulder and full-arm circling;
- Education;
- Nutritional programs and psychosocial counselling, when appropriate. A multidisciplinary team of chest physicians, nurses, physical therapists, a dietician, and a psychologist offered care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of moderate-to-severe COPD (ATS-ERS definition)
- •Patients who have not participated in a respiratory rehabilitation program within the previous 3 months
- •Patients admitted to the multi-specialist Rehabilitation Center Auxilium Vitae Volterra SPA for inpatient PR programme
- •stable clinical conditions and absence of clinical deterioration, with stable dyspnea, cough and sputum; stability of blood gas values in the absence of signs of edema or heart failure
- •Expression of informed consent valid for participation in the study
- •Good collaboration in the activities foreseen by the study
排除标准
- •Insufficient degree of cooperation
- •Inability to walk independently
- •Denial of informed consent to participate in the study
- •patients with known serious cardiovascular diseases (unstable angina, advanced chronic heart failure, aortic aneurisms, etc.) contraindicating the inclusion in exercise training programmes; chronic neurological or musculoskeletal diseases impairing their ability to comply with study procedures; severe renal failure or end-stage dialysis, advanced cancer, epilepsy and other clinical conditions interfering with the procedures and the safety of the study.
研究组 & 干预措施
Transcutaneous Electrical Nerve Stimulation (TENS)
15 experimental subjects treated withTENS and Pulmonary Rehabilitation
干预措施: TENS and pulmonary rehabilitation (Device)
Rehabilitation
15 experimental subjects treated with Pulmonary Rehabilitation only
结局指标
主要结局
Baseline dyspnea evaluated with Baseline Dyspnea Index (BDI)
时间窗: baseline
Assessment of the perception of dyspnea with the basal dyspnea index (BDI) which measures the severity of dyspnea in a single state. The score ranges from 0 to 12. The lower the score, the worse the dyspnea severity
Transitional dyspnea evaluated with Transitional Dyspnea Index (TDI)
时间窗: 2 week and 4 week
Evaluation of the perception of dyspnea with a transitional dyspnea index (TDI) that measures changes in the severity of dyspnea compared to the baseline established by the Baseline Dyspnea Index (BDI). Rated from seven degrees ranging from -3 (major deterioration) to +3 (major improvement).
次要结局
- Change in quality of life: SGRQ (St. George's Respiratory questionnaire)(baseline ,2 week and 4 week)
- Change in respiratory muscle function(baseline, 2 and 4 week)
- Change in lung diffusion capacity(baseline, 2 and 4 week)
- Change in functional capacity with the six-minute walk test (6mwt)(baseline , 2 and 4 week)
- Change in respiratory volumes(baseline, 2 and 4 week)
- Impact of the disease(baseline, 2 and 4 week)
- Patient's dissociative experience related to the stress measured with the Dissociative Experiences Scale (DES)(baseline, 2 and 4 week)
研究者
Alessandro Tani
Doctor in Department of Anesthesia and Intensive Care Unit
Azienda USL Toscana Nord Ovest