The influence of a Pulsating Electrostatic Field (PESF) on oxygen saturation, quality of life and exercise capacity of COPD patients, a single center, double blind, placebo controlled study. - Influence of PESF on oxygen saturation, QoL and exercise capacity in COPD

Heerenveen Ziekenhuis, De Tjongerschans0 个研究点目标入组 32 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- 40-85 years old
•- Male and female
•- 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 to ability to decide on participation
•- Signed form of consent

•- Known malignant condition with limited life expactancy
•- Carrier of electrical equipment (pacemaker, ICD etc.)
•- COPD exacerbation in the last 3 weeks
•- Participation in other research
•- Woman who are pregnant, breastfeeding or of childbearing age without effective contraception unless they meet the postmenopausal definition: 12 months of natural omenorrhea or 6 months of spontaneous ammenorrhea with serum FSH>40 mIU/mL or the use of one or more of the following acceptable methods of birth control: a) surgical sterilication, b) hormonal contraception, c) barrier methods: condom or occlusion cap with spermicide, d) constant abstention.
•- Manifest acute inflammation
•- Patients with manifest decompensatio cordis
•- Rehabilitation/reactivation programs within 2 months before or during the study

发起方

Heerenveen Ziekenhuis, De Tjongerschans