Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT03797794
Status:
TERMINATED
Last Update Posted:
2024-01-19
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
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.
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Logistical problems at study site
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: