Not provided
Not provided
Not provided
Not provided
Not provided
Logistical problems at study site
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tjongerschans hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PESF-treatment | Experimental | The group undergoing the pulsating electrostatic field intervention |
|
| Placebo-treatment | Sham Comparator | The group undergoing the SHAM Pulsating Electrostatic Field |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsating Electrostatic Field | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of oxygen saturation | Difference in oxygen saturation before first vs after last session | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of quality of life | Difference in CCQ score before first vs after last session | 5 days |
| Improvement of exercise capacity | Difference in 6-MWT outcome before first vs after last session |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tjongerschans | Heerenveen | Provincie Friesland | 8441 PW | Netherlands |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
prospective, randomized, dubbel blind, placebo-controlled parallel study
Not provided
Not provided
Not provided
| SHAM Pulsating Electrostatic Field | Device | The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo. |
|
| 5 days |
| Improvement of phase angle | Difference in oxygen saturation before first vs after last session | 5 days |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |