Evaluation of Utility Quadriceps Magnetic Stimulation in COPD (Chronic Obstructive Pulmonary Disease) Patients After Hospital Exacerbation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Six minute walking distance
研究概览
简要总结
The aims of this study are:1.To evaluate the utility of quadriceps RMNMS (repetitive magnetic neuromuscular stimulation) in the evolution of COPD patients after hospital admission for acute exacerbation.2 To evaluate the time schedule of recovery changes in muscle parameters ,exercise capacity and quality of life after acute exacerbation. 3.To test the use of this new method of training in acute clinical situations. Patients: COPD patients admitted to the Hospital with acute exacerbation. Group 1: RMNMS Treatment .Group 2 : sham RMNMS treatment. Randomized assignment by minimization method. PROTOCOL Training Group: 10 days after discharge and during 8 weeks, 2-3 days/week.
Measures: Spirometry, Plethysmography ,Diffusion Test. Main outcomes: Exercise test (Six minutes walking distance). Muscle function: MVC. Health related quality of life.
详细描述
Study type Randomized controlled clinical trial with the aim of evaluating an eight-week protocol of repetitive magnetic stimulation (RMNMS) of the quadriceps muscle in COPD patients after inhospital treated exacerbations. The outcomes to be assessed are parameters relating to quadriceps muscle function, exercise capacity (Six minutes walking distance, 6MWD) and quality of life.
Study design and procedures:
Patients will receive information about the investigation, the procedures that will be carried out and their risks, and shall provide written consent in the consent form approved by the Cruces Hospital Ethics and Clinical Trials Committee. Regarding outcome evaluations, all patients, on full intensity and sham RMNMS, will be subjected to identical assessments and functional procedures.
Evaluation for inclusion includes clinical anamnesis and physical exam, chest X-ray evaluation and general blood exam and biochemistry, including creatine kinase (CK) and lactic dehydrogenase (LD). In the week before the start of stimulation treatment and 3 month after hospital discharge, following measurements will be carried out:
- Pulmonary function tests
- Health-related quality of life, using the SF3626 and the Saint George Respiratory Questionnaire(SGRQ), both self administered.
- Body composition: fat-free mass (FFM) using the bioelectric impedance method (Bodystat-500 Bodystat Ltd, Douglas, UK) and expressed as a fat-free mass index (FFMI), which is the result of FFM/(height)2, height expressed in meters.
- Peripheral muscle function: Maximal voluntary contraction of the quadriceps (MVCQ) measured in five maximum isometric contraction efforts (knee-extension attempts) using a Biopac dynamometer (TSD 121C), Biopac system (Biopac System, La Jolla CA, USA) and AcqKnowledge software.
- Six-minute walking test (6MWT): carried out over the same 30 m stretch, according to the standard procedure.(Am J Respir Crit Care Med 2002;166:111e7.) A minimum of three measurements shall be carried out in the initial assessment and two during post-protocol evaluation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and functional diagnosis of COPD.
- •Hospital admission because of COPD exacerbation in respiratory department, ICU or emergency department
- •Hospital discharge.
排除标准
- •Cardiac pacemaker.
- •Exacerbation because of major Heart disease or pulmonary embolism.
- •Lung cancer or disseminated neoplasic disease.
- •Severe renal or hepatic disease.
- •neurological disease, musculoskeletal or cardiovascular or on any treatment that might interfere with the completion of the protocol and the assessment of functional outcomes.
结局指标
主要结局
Six minute walking distance
时间窗: 3 months
One week after hospital release patients are evaluated and initiate treatment with intense magnetic stimulation or placebo. Measurements are repeated after 3 months.
次要结局
- quality of life CRQ(3 months)
- Maximal voluntary contraction of the quadriceps(three months)