Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD

Study Overview
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Brief Summary
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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.

Official Title
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The Influence of Pulsating Electrostatic Field (PESF) on Oxygen Saturation, Quality of Life and Exercise Capacity of COPD Patients, a Single Center, Double Blind, Placebo Controlled Study.

Conditions
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COPD

Intervention / Treatment
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* Device: Pulsating Electrostatic Field
* Device: SHAM Pulsating Electrostatic Field


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, dubbel blind, placebo-controlled parallel study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PESF-treatment<br>The group undergoing the pulsating electrostatic field intervention | Device: Pulsating Electrostatic Field<br>* A pulsating electrostatic field is generated by the New Health 9000 (Akern). During the session the patients sits on a chair which contains the apparatus for 30 minutes.<br>|
| Sham Comparator: Placebo-treatment<br>The group undergoing the SHAM Pulsating Electrostatic Field | Device: SHAM Pulsating Electrostatic Field<br>* The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of oxygen saturation | Difference in oxygen saturation before first vs after last session | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of quality of life | Difference in CCQ score before first vs after last session | 5 days | 
| Improvement of exercise capacity | Difference in 6-MWT outcome before first vs after last session | 5 days | 
| Improvement of phase angle | Difference in oxygen saturation before first vs after last session | 5 days |