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

January 17, 2024 updated by: Huib A.M. Kerstjens, University Medical Center Groningen

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Friesland
      • Heerenveen, Friesland, Netherlands, 8441 PW
        • Tjongerschans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

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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