Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD (NCT03797794) | Clinical Trial Compass
TerminatedNot Applicable
Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD
Stopped: Logistical problems at study site
Netherlands10 participantsStarted 2019-01-01
Plain-language 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 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.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.