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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54846
Enrollment
34
Registered
2019-12-12
Start date
2022-04-13
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

chronic obstructive lungdisease COPD

Interventions

Group 1 will be treated with PESF for 30 minutes in 3 consecutive sessions, in a working week. Group 2 will undergo 3 sham sessions of 30 minutes in the same way. After a "wash-out" period of 30 day

Sponsors

OLVG
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: ­- 40­-85 years old ­- Male and female ­- COPD patients, post­bronchodilator 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
Primary study parameter is distance measured in 6MWT immediately after the first treatment and cumulatively after 3 consecutive treatments with PESF.

Secondary

MeasureTime frame
- Quality of life (CCQ) and BORG score as measured in 6MWT - Oxygen saturation during and up to 24hours after the PESF/ Sham treatment - spirometry and diffusion - phase angle

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)