Primary objective: *What is the effect of an incremental maximal exercise test on inflammation in patients with cystic fibrosis and in healthy people?*Secundary objectives:- What are the differences in basal immune values between HP and CF patients…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary determinant: graded maximal exercise test.
The primary endpoint: exercise induced inflammatory response (EIIR). The EIIR
is the difference between pre-exercise immune levels and post-exercise immune
levels.
Secondary outcome
There are no secundary study parameters.
Secundary endpoints:
- Basal immune values (measurement t0).
- Maximal exercise capacity: this will be determined by the following values:
peak heart rate (HRpeak; beats/ min), RER, ventilation threshold (L/ min)
according to the equivalent method100, peak oxygen uptake (VO2peak; L/ min)101,
peak workload (Wpeak; watt)102, efficiency (ΔVO2/Δworkload; L/ min/ watt)103,
maximal voluntary ventilation (VEpeak; L/ min), and oxygen saturation decrease
(SaO2-decrease; %), whole blood lactate (mmol/ mL).
- Exercise intolerance: when the participant has finished the maximal exercise
before fully exhaustion. As mentioned in section 6.1.1. ad 1, this can be
estimated by HRpeak and the RER.
- Exercise induced dyspnoea perception and muscle fatigue perception: at the
end of each maximal exercise test, participants are asked to score their sense
of dyspnoea and muscle effort/ fatigue at peak exercise using Borg scales.104
scored with the Borg scale (see section F, appendix 2).104;105
- Terminating the maximal exercise test prior to reaching voluntary exhaustion.
Background summary
Exercise has been shown to induce a pattern of hormonal and immunologic
responses similar to many known clinical physical stressors (e.g. surgery, and
sepsis). When healthy people are subjected to a brief bout of exercise, this
induces an immune modulation including transient increases in leukocytes,
lymphocytes, natural killer cells and cytokines. Changes in levels of different
immune parameters followed by exercise have been attributed to changes in the
stress hormones, catecholamines and cortisol.
These changes are positive related with exercise intensity: how bigger the
intensity, wow bigger the response.
Hypothetically, the defence against micro-organisms will be better when the
serum concentration of immune cells increase. However, an excessive and/ or
sustained inflammatory response can also induce damage to cells and organ
systems. Besides this, exercise with a high intensity (e.g. a marathon) can
even induce an immune depression.
In contrast to the large number of studies in healthy subjects of the immune
response to acute exercise, much less is known concerning the effect of an
acute exercise test on the inflammatory response in CF patients.
Exercise is part of the treatment in CF patients, because it has many benefits
for CF patients:
- physical fitness increases
- lungfunction is maintains or even increases
- quality of life increases
- Survival increases
Patients with cystic fibrosis (CF) have a chronic inflammatory status. So the
question is if the same perceptions will be seen in CF patients in comparison
with healthy people as a response to an acute bout of exercise.
Exercise seems to have many beneficial effects, but is this also true for the
influence of exercise on the immune system in CF patients? In CF patients
regular exercise might be beneficial for the defense against micro-organisms.
But it also may induce a bigger and longer lasting response which can cause
tissue damage. And what will be the effect of an acute exercise test on
inflammation during a period of an exacerbation? Is it justified to exercise
during a period of an exacerbation? In this study we try to give answers to
these questions.
Study objective
Primary objective: *What is the effect of an incremental maximal exercise test
on inflammation in patients with cystic fibrosis and in healthy people?*
Secundary objectives:
- What are the differences in basal immune values between HP and CF patients,
and between CF patients in a clinically stable condition and CF patients with
an exacerbation?
- What is the difference in maximal exercise capacity between HP and CF
patients, and between CF patients with a clinically stable condition and CF
patients with an exacerbation?
- What is the difference in breathlessness and muscle fatigue between HP and CF
patients, and between CF patients with a clinically stable condition and CF
patients with an exacerbation?
- What is the correlation between pulmonary function (disease severity) and the
exercise induced inflammation, and between pulmonary function and basal immune
values?
- What is the correlation between maximal exercise capacity and the exercise
induced inflammation, and between maximal exercise capacity and basal immune
values?
Study design
This investigation is an intervention study with a within-subject-design. The
purpose of this investigation is to establish the exercise induced inflammatory
response (EIIR) in CF patients and in healthy people (HP). The EIIR is the
difference between pre-exercise immune levels and post-exercise immune levels.
Intervention
Niet van toepassing
Study burden and risks
Minor CF patients are needed to accomplish this study. CF is a progressive
disease and it manifests most of the times at a young age. Older CF patients
are most of the times more severe ill and have more damage to their organ
systems. More severe lung disease is an extra burden for the participant, when
he or she should participate.
We realise that every investigation and every measurement will be a burden for
the participant, especially for children. Though, we think that the
investigation is justified. The risks, and side-effects of the investigation
will be minimal. The
Possible risks of placement of an i.v. access: phlebitis, bacteraemia,
vasovagal collapse
Possible risks of executing a maximal exercise test: decrease of oxygen
saturation (especially in CF patients), sense of breathlessness, exercise
induced symptoms like pijn, a headache, dizziness, syncope, arrhytmia.
Lundlaan 6
P.O. Box 85090, 3508 AB Utrecht
Nederland
Lundlaan 6
P.O. Box 85090, 3508 AB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria which can be applied for the CF patients:
- CF patients diagnosed by clinical features and a positive sweat chloride test with a homozygote *F508 mutation
- CF patients in a clinically stable period: clinically stable means clinically stable for at least 4 weeks, since the exacerbation period. This means no use of (extra) oral or intravenous antibiotics for at least 4 weeks
- CF patients with a doctor*s diagnosed acute exacerbation: this exacerbation needs treatment in the hospital with intravenous antibiotics.
- Age: 12 to 18 years old
- Sex: male and female;Inclusion criteria which can be applied for the healthy people:
Healthy adults:
- > 18 years old
- Sex: male and female
Healthy children:
- Age: 12 to 18 years old
- Sex: male and female
Exclusion criteria
Exclusion criteria which can be applied for the CF patients:
- Subjects with a physical exercise contraindication by a medical specialist
- Subjects with a known contra-indicatory disease for exercise testing: acute or chronic cardiovascular disease, other pulmonary diseases than cystic fibrosis, acute renal disease, acute hepatitis, metabolic disorders, hemorrhagic diseases, orthostatic hypotension 90;91
- Subject with a known disease which can influences the immune system: acute or chronic inflammatory diseases, acute infection*
- Subjects who used (inhalation) corticosteroids, and/ or immunosuppressive therapy the last month
- Subjects who used extra antibiotics, on top of their prophylactic antibiotic treatment (regular treatment) within 4 weeks prior to the exercise testing.*
- Subjects who have had a lung transplantation
- Subjects who smoke
* This exclusion criteria is not applied to CF patients with an exacerbation.;Exclusion criteria with regard to the healthy people:
- Subjects with a physical exercise contraindication by a medical specialist
- Subjects with a known contra-indicatory disease for exercise testing: acute or chronic cardiovascular disease, acute or chronic pulmonary disease, acute renal disease, acute hepatitis, metabolic disorders, hemorrhagic diseases, orthostatic hypotension 90;91
- Subject with a known disease which can influences the immune system: acute or chronic inflammatory diseases, acute infection*
- Subjects who smoke
- Subjects who used antibiotics, immunosuppressive therapy, and/ or (inhalation) corticosteroids within one month prior to the exercise testing
Design
Recruitment
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 | NL19968.000.07 |