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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD

Interventions

Type	Name	Description
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.
DEVICE	SHAM Pulsating Electrostatic Field	The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo.

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-01-09
• Last updated: 2024-01-19

Locations

1 site across 1 country: Netherlands