Status:
TERMINATED
Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Tjongerschans hospital
Conditions:
COPD
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03797794
Start Date
January 1 2019
End Date
December 31 2023
Last Update
January 19 2024
Active Locations (1)
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1
Tjongerschans
Heerenveen, Provincie Friesland, Netherlands, 8441 PW