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

COPD Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03797794
• Other study ID #: PESF and COPD
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Pulsating Electrostatic Field
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 Pulsating Electrostatic Field
The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo.

Locations

Country	Name	City	State
Netherlands	Tjongerschans	Heerenveen	Friesland

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Tjongerschans hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of oxygen saturation	Difference in oxygen saturation before first vs after last session	5 days
Secondary	Improvement of quality of life	Difference in CCQ score before first vs after last session	5 days
Secondary	Improvement of exercise capacity	Difference in 6-MWT outcome before first vs after last session	5 days
Secondary	Improvement of phase angle	Difference in oxygen saturation before first vs after last session	5 days