Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD Controlled, Randomized, Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- six minute walk test (6MWT)
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is nowadays the 4th cause of death in the world and it´s expected to become the 3rd cause of death in 2020 and the majority cause of morbidity. Besides that, in Portugal COPD patients become more dependents each day.
Acupuncture as a reflex therapy it´s carried out through a Traditional Chinese Medicine (TCM) diagnose that will allowed to identify the acupoints.
The investigators are interested in to assess acupuncture efficacy on physical exercise tolerance in COPD patients.An experimental, controlled, randomized, double blind study was done. Patients were recruited according TCM diagnose to optimize potential therapeutic effects.
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, Investigator)
盲法说明
Patients didn´t know what kind of therapy they were submitted The acupuncturist was a nurse, able to do invasive procedures with no knowledge of Chinese Medicine, and totally blind in terms of the verum or sham acupuncture.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD GOLD III,IV;
- •able to walk;
- •Informed consent signed;
- •stable medication during last 3 days
- •exacerbation during 3 months;
- •Chinese diagnose opening principle;
- •blood pressure "90"180 mmhg/ "100mmhg; respiratory rate "10"30 cpm
排除标准
- •metastasis;
- •renal or cardiovascular disease;
- •pulmonary hypertension;
- •COPD symptoms exacerbation during the therapy;
- •previous acupuncture treatments;
- •unstable vital signs;
- •pulmonary rehabilitation in the last 6 months;
- •needle phobia.
研究组 & 干预措施
Verum acupucnture
Real acupuncture treatment
干预措施: acupuncture (Procedure)
sham acupuncture
False acupuncture treatment using not acupuncture points
干预措施: acupuncture (Procedure)
结局指标
主要结局
six minute walk test (6MWT)
时间窗: 6 minutes
distance walked (metres)
次要结局
- Rating of perceived exertion (Borg Scale)(6 minutes)
- Oxygen peripheral saturation (SPO2)(6 minutes)
- Blood pressure(6 minutes)
- heart rate(6 minutes)
研究者
Carla Manuela Loureiro Barros
Master student
Instituto de Ciências Biomédicas Abel Salazar