The Influence of Pulsating Electrostatic Field (PESF) on Oxygen Saturation, Quality of Life and Exercise Capacity of COPD Patients, a Single Center, Double Blind, Placebo Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Improvement of oxygen saturation
研究概览
简要总结
The effect of PESF (Pulsating Electrostatic Field) on the oxygen saturation, quality of life and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled parallel design with 32 COPD patients GOLD III and IV with a oxygen saturation below or equal to 90%.
The patients will be treated with three 30-minute PESF- or placebo-sessions distributed over 5 days.
Directly before the first session, oxygen saturation, quality of life (CCQuestionnaire), exercise capacity (6-MWT and grip strength) and phase angle (BIA) will be measured and compared to the results directly after the third session. Oxygen saturation is also monitored during 24 hours after each session.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients, post-bronchodilator FEV1/FVC <70% and FEV1 <50% predicted
- •oxygen saturation without suppletion <=90% (home use of oxygen suppletion is allowed, but will be stopped during PESF-treatment)
- •Stable medication (no foreseeable need to change therapy)
- •Able to understand the purpose and method of research after adequate information and the ability to decide on participation
- •Signed informed consent
排除标准
- •Known malignant condition with limited life expectancy
- •Carrier of electrical equipment (pacemaker, ICD etc)
- •COPD exacerbation in the last 3 weeks
- •Woman who are pregnant or of childbearing age without effective contraception
- •Manifest acute infection
- •Patients with manifest decompensatio cordis
- •Rehabilitation/reactivation program within 2 months before or during the study
研究组 & 干预措施
PESF-treatment
The group undergoing the pulsating electrostatic field intervention
干预措施: Pulsating Electrostatic Field (Device)
Placebo-treatment
The group undergoing the SHAM Pulsating Electrostatic Field
干预措施: SHAM Pulsating Electrostatic Field (Device)
结局指标
主要结局
Improvement of oxygen saturation
时间窗: 5 days
Difference in oxygen saturation before first vs after last session
次要结局
- Improvement of quality of life(5 days)
- Improvement of phase angle(5 days)
- Improvement of exercise capacity(5 days)
研究者
Huib A.M. Kerstjens
Head of the department Pulmonary diseases and Tuberculosis
University Medical Center Groningen