- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03797794
Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jaap Westbroek
- Phone Number: 0513-685227
- Email: j.westbroek@tjongerschans.nl
Study Contact Backup
- Name: Huib Kerstjens
- Email: h.a.m.kerstjens@umcg.nl
Study Locations
-
-
Friesland
-
Heerenveen, Friesland, Netherlands, 8441 PW
- Tjongerschans
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PESF-treatment
The group undergoing the pulsating electrostatic field intervention
|
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.
|
Sham Comparator: Placebo-treatment
The group undergoing the SHAM Pulsating Electrostatic Field
|
The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'.
This inlet will be used as placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of oxygen saturation
Time Frame: 5 days
|
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
Time Frame: 5 days
|
Difference in CCQ score before first vs after last session
|
5 days
|
Improvement of exercise capacity
Time Frame: 5 days
|
Difference in 6-MWT outcome before first vs after last session
|
5 days
|
Improvement of phase angle
Time Frame: 5 days
|
Difference in oxygen saturation before first vs after last session
|
5 days
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PESF and COPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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