Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD

NCT03797794 | Terminated

• 1 other identifier: PESF and COPD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Improvement of oxygen saturation

  Difference in oxygen saturation before first vs after last session

  5 days

Secondary Outcomes (3)

• Improvement of quality of life

  5 days

• Improvement of exercise capacity

  5 days

• Improvement of phase angle

  5 days

Study Arms (2)

PESF-treatment

EXPERIMENTAL

The group undergoing the pulsating electrostatic field intervention

Device: Pulsating Electrostatic Field

Placebo-treatment

SHAM COMPARATOR

The group undergoing the SHAM Pulsating Electrostatic Field

Device: SHAM Pulsating Electrostatic Field

Interventions

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.

PESF-treatment

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.

Placebo-treatment

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Tjongerschans hospital: collaborator

Study Sites (1)

Tjongerschans

Heerenveen, Provincie Friesland, 8441 PW, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department Pulmonary diseases and Tuberculosis

Model Details: prospective, randomized, dubbel blind, placebo-controlled parallel study

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

NL (1)