Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD
Key facts
- Who runs it
- University Medical Center Groningen
- Where
- Netherlands1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 10 people enrolled
- Started
- 1 Jan 2019
- Ended
- 31 Dec 2023
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Pulsating Electrostatic Field
- SHAM Pulsating Electrostatic Field
- Record updated
- 19 January 2024
- Why it stopped
- Logistical problems at study site
Who can take part
- Age
- 40 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Rehabilitation/reactivation program within 2 months before or during the study
- Known malignant condition with limited life expectancy
- Manifest acute infection
- Woman who are pregnant or of childbearing age without effective contraception
- Carrier of electrical equipment (pacemaker, ICD etc)
- COPD exacerbation in the last 3 weeks
- Patients with manifest decompensatio cordis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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%.
Read full original descriptionShow less
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 2 groups in the trial
- PESF-treatmentTreatment being tested
The group undergoing the pulsating electrostatic field intervention
Treatment: Pulsating Electrostatic Field
- Placebo-treatmentSham treatment, for comparison
The group undergoing the SHAM Pulsating Electrostatic Field
Treatment: SHAM Pulsating Electrostatic Field
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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.
- Record updated
- 19 January 2024