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

Phase 2

Completed

Conditions: chronic obstructive lungdisease
COPD
10006436

Registration Number: NL-OMON54846

Lead Sponsor: OLVG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

- 40-85 years old
- Male and female
- COPD patients, postbronchodilator FEV1/FVC <70%, and FEV1 < 50%predicted.
- 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>Primary study parameter is distance measured in 6MWT immediately after the<br /><br>first treatment and cumulatively after 3 consecutive treatments with PESF.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Quality of life (CCQ) and BORG score as measured in 6MWT<br /><br>- Oxygen saturation during and up to 24hours after the PESF/ Sham treatment<br /><br>- spirometry and diffusion<br /><br>- phase angle</p><br>