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The influence of a Pulsating Electrostatic Field (PESF) on oxygen saturation, quality of life and exercise capacity of COPD patients, a single center, double blind, placebo controlled study.

The influence of a Pulsating Electrostatic Field (PESF) on oxygen saturation, quality of life and exercise capacity of COPD patients, a single center, double blind, placebo controlled study. - Influence of PESF on oxygen saturation, QoL and exercise capacity in COPD

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46616
Enrollment
32
Registered
2018-08-30
Start date
2019-01-28
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic bronchitis COPD

Interventions

16 Patients will receive 3 PESF treatments in 1 week and 16 patients will receive 3 placebo treatments in 1 week.

Sponsors

Heerenveen Ziekenhuis, De Tjongerschans
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 40-85 years old - Male and female - COPD patients, post-bronchodilator FEV1/FVC

Exclusion criteria

Exclusion criteria: - Known malignant condition with limited life expactancy - Carrier of electrical equipment (pacemaker, ICD etc.) - COPD exacerbation in the last 3 weeks - Participation in other research - Woman who are pregnant, breastfeeding or of childbearing age without effective contraception unless they meet the postmenopausal definition: 12 months of natural omenorrhea or 6 months of spontaneous ammenorrhea with serum FSH>40 mIU/mL or the use of one or more of the following acceptable methods of birth control: a) surgical sterilication, b) hormonal contraception, c) barrier methods: condom or occlusion cap with spermicide, d) constant abstention. - Manifest acute inflammation - Patients with manifest decompensatio cordis - Rehabilitation/reactivation programs within 2 months before or during the study

Design outcomes

Primary

MeasureTime frame
- oxygen saturation just before the first and immediately after the last PESF/placebo treatment - cap gas - CCQ-score (quality of life) - 6 minute walking test - squeenze force - phase angle (as a measurement for the muscle cell condition) - lung function

Secondary

MeasureTime frame
- oxygen saturation during and up to 24 hours after the PESF/placebo treatments

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)