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.

Phase 2

Completed

Conditions: chronic bronchitis
COPD
10006436

Registration Number: NL-OMON46616

Lead Sponsor: Heerenveen Ziekenhuis, De Tjongerschans

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- oxygen saturation just before the first and immediately after the last<br /><br>PESF/placebo treatment<br /><br>- cap gas<br /><br>- CCQ-score (quality of life)<br /><br>- 6 minute walking test<br /><br>- squeenze force<br /><br>- phase angle (as a measurement for the muscle cell condition)<br /><br>- lung function</p><br>

Secondary Outcome Measures