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 range40 Years – 85 Years

SexALL

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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

What they're measuring

Improvement of oxygen saturation

Timeframe: 5 days

Trial details

NCT IDNCT03797794

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31