COPD
Conditions
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.
Interventions
DEVICEPulsating 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.
DEVICESHAM Pulsating Electrostatic Field
The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo.
Sponsors
Tjongerschans hospital
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
prospective, randomized, dubbel blind, placebo-controlled parallel study
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of oxygen saturation | 5 days | Difference in oxygen saturation before first vs after last session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Improvement of phase angle | 5 days | Difference in oxygen saturation before first vs after last session |
Countries
Netherlands
Outcome results
None listed