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

Not Applicable

Terminated

• Conditions: COPD
• Interventions: Device: Pulsating Electrostatic Field; Device: SHAM Pulsating Electrostatic Field

• Registration Number: NCT03797794
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PESF-treatment	Pulsating Electrostatic Field	The group undergoing the pulsating electrostatic field intervention
Placebo-treatment	SHAM Pulsating Electrostatic Field	The group undergoing the SHAM Pulsating Electrostatic Field

Primary Outcome Measures

Name	Time	Method
Improvement of oxygen saturation	5 days	Difference in oxygen saturation before first vs after last session

Secondary Outcome Measures

Name	Time	Method
Improvement of phase angle	5 days	Difference in oxygen saturation before first vs after last session
Improvement of quality of life	5 days	Difference in CCQ score before first vs after last session
Improvement of exercise capacity	5 days	Difference in 6-MWT outcome before first vs after last session

Trial Locations

Locations (1)

Tjongerschans; 🇳🇱 Heerenveen, Friesland, Netherlands