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

University Medical Center Groningen (UMCG)

Status: Terminated

Conditions: COPD

Treatments: Device: Pulsating Electrostatic Field; Device: SHAM Pulsating Electrostatic Field

Study type: Interventional

Funder types: Other

Identifiers

NCT03797794

PESF and COPD

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

PESF-treatment

Experimental group

Description:

The group undergoing the pulsating electrostatic field intervention

Treatment:

Device: Pulsating Electrostatic Field

Placebo-treatment

Sham Comparator group

Description:

The group undergoing the SHAM Pulsating Electrostatic Field

Treatment:

Device: SHAM Pulsating Electrostatic Field