Primary objective:- Improvement of walking distance in 6MWT immediately after the first treatment and cumulatively after 3 consecutive treatments with PESFSecundary objectives:- improvement of oxygen saturation - improvement of quality of life-…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter is distance measured in 6MWT immediately after the
first treatment and cumulatively after 3 consecutive treatments with PESF.
Secondary outcome
- 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
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.
A pilot study showed an improvement of exercise capacity, (temporary
improvement of) oxygen saturation, and quality of life, seen in a small group
of the same research population. Whether this temporary effect of 6 hours on
oxygen saturation has an effect on the distance to walk with the 6MWT is
insufficiently clear. It is speculative to assume that the walking distance and
oxygen saturation are independent parameters.
The question of whether the effect of PESF on the 6MWT is temporary (6 hours)
or longer, is now unknown and has not been included in the analysis.
Study objective
Primary objective:
- Improvement of walking distance in 6MWT immediately after the first treatment
and cumulatively after 3 consecutive treatments with PESF
Secundary objectives:
- improvement of oxygen saturation
- 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
Single center, randomized, sham controlled, crossover study in 34 patients with
COPD GOLD III / IV, with a walking distance in the 6MWT <500m. These patients
will initially be randomized into 2 groups. 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 days, group 1 will be treated with sham sessions and group 2 with
PESF. Ultimately, therefore, each participant will be exposed to both PESF and
a sham procedure. The study will be conducted at the OLVG hospital, location
Oost in Amsterdam.
Intervention
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 days, group 1 will be treated with sham
sessions and group 2 with PESF.
Study burden and risks
Burden and risks of this research are negligible. The PESF treatment takes 30
minutes; the outcome tests are non-invasive In addition, the PESF treatment
has no relevant side effects. The PESF machine (New Health 9000, Akern) is CE
qualified.
After treatment, the patient will use the continuous oxygen saturation monitor
at home for 24 hours, which may be considered unpleasant.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
- 40-85 years old
- Male and female
- COPD patients, postbronchodilator FEV1/FVC <70%, and FEV1 < 50%predicted.
- 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 | NL70664.100.19 |