Primary objectives:- improvement of oxygen saturation Secondary objectives:- improvement of quality of life- improvement of exercise capacity- improvement of muscle power- improvement of phase angle- registration of potential short term and long…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
- oxygen saturation during and up to 24 hours after the PESF/placebo treatments
Background summary
Treatment with PESF has been in use for many years for different clinical
indications as well as by top athletes. It has been mainly used for quick
recovery of the body, muscle damage or pain during and after strenuous
exercise. In addition, positive influences of PESF treatments have been found
in diabetic patients, such as improvement of basal metabolic rate, improvement
of wound repair of foot wounds, polyneuropathy and by promotion of
microvascular blood flow. Also positive effects in COPD patients haven been
found, such as stabilization or improvement of oxygen saturation, quality of
life and exercise capacity. The mechanism of action is still unknown. The
current hypothesis of the mechanism of action is the reduction of rouleaux
formation of red blood cells by improvement of intracellular pH and improvement
of the autonomous control of smooth muscle cells of the arterioles.
Study objective
Primary objectives:
- improvement of oxygen saturation
Secondary objectives:
- improvement of quality of life
- improvement of exercise capacity
- improvement of muscle power
- improvement of phase angle
- registration of potential short term and long term side effects
Study design
The study is designed as a single center, randomized, placebo-controlled,
parallel study of 32 COPD GOLD class III and IV patients. 16 patients will
undergo 3 PESF sessions of 30 minutes during 1 week and 16 patients will
undergo 3 sham PESF sessions of 30 minutes. Before and after the
PESF-treatments, lung function, squeeze force, phase angle, 6 minute walking
test will be measured. The quality of life will be measured before, after and
during the treatments. In addition, oxygen saturation will be measured
continuously using a continuous oxygen saturation monitor.
Intervention
16 Patients will receive 3 PESF treatments in 1 week and 16 patients will
receive 3 placebo treatments in 1 week.
Study burden and risks
Burden and risks of this research are negligible. Overall the patients will be
done in 3 to 4 hours. The treatment itself lasts 30 minutes, most of the tests
are non-invasive and most of them are already familiar to the patients. In
addition, the treatment has no or hardly any side effects and the New Health
9000 (Akern) has a CE quality mark. The patient will be asked to use the
continuous oxygen saturation monitor at home, which may be considered
unpleasant.
Koedijklaan 2
Bussum 1406 KZ
NL
Koedijklaan 2
Bussum 1406 KZ
NL
Listed location countries
Age
Inclusion criteria
- 40-85 years old
- Male and female
- 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 to ability to decide on participation
- Signed form of consent
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64047.042.17 |