Primary objective is to assess the association between SAF and physical activity in well trained and in untrained people, and in people who have a previous cardiovascular disease. Secondary objective is, to assess if an association exists between…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameter is SAF.
Secondary outcome
Secondary study parameters are the frequency (times per week) and duration
(minutes per session) of physical activity, the structure and function of the
Achilles tendons, and vascular compliance.
Background summary
AGEs (Advanced Glycation Endproducts) accumulate in the skin while ageing, this
is accelerated by glycemic and oxidative stress. One can easily measure the
accumulation of AGEs by using skin autofluorescence (SAF). SAF is an
independent predictor of (new) cardiovascular diseases (CVD) in diabetes, renal
failure and existing CVD and it is related to other ageing processes. Regular
moderate physical activity has a beneficial influence on state of health in the
adult population. At the same time, physical activity can improve the prognosis
(and survival) in patients with chronic diseases, such as diabetes, or CVD. On
the other hand, extreme physical activity can cause injuries, overtraining and
is correlated with an increased mortality risk.
Animal studies show that regular moderate physical activity has a beneficial
influence on AGE accumulation and formation. Moreover, research in humans also
provides evidence for this beneficial influence. On the other hand, increased
AGE accumulation is related to an increased risk of injuries to the vascular
system, tendons and bone. In this project we try to examine the role of SAF in
this two sided effect of physical activity. Therefore, the hypothesis is that
regular moderate physical activity lowers, and extreme physical activity
increases AGE levels (measured by using SAF). Furthermore, we expect that SAF
will be related to tendon and vascular compliance characteristics measured at
baseline.
Study objective
Primary objective is to assess the association between SAF and physical
activity in well trained and in untrained people, and in people who have a
previous cardiovascular disease. Secondary objective is, to assess if an
association exists between SAF and tendon- and vascular characteristics.
Study design
Cohort and intervention study, consisting of two different sub studies:
A: Investigate the effect of performing one single bout of maximal exercise on
SAF in well trained and untrained people, stratified for age/gender.
B: Assess the change of SAF during a 12 week training program, stratified for
age/gender.
Intervention
In part B effects of an 12 week training program on SAF will be examined;
participants of groups 1, 2 and 3 will follow their regular training or
rehabilitation program and matches. Measurements will be conducted after 0, 6
and 12 weeks, participants in group 3 will be measured again after one year.
During these 12 weeks the participants will fill in a diary to keep track of
the training sessions and matches. The control group will not follow a training
program, however they do have to fill in the diary to keep track of their
activities.
Study burden and risks
All performed measurements are non-invasive and therefore only minor risks are
associated with participation. The use of SAF as measure for accumulation of
AGEs in (longlived) skin/dermis measured with the AGE reader is widely
accepted. AGE reader measurements, UTC (Ultrasound Tissue Characterization)
imaging and PWV (Pulse Wave Velocity) measurements are non-invasive and the
ultrasound waves of UTC imaging are not harmful for the subject. When
unexpected findings are found within the measurements, the participant and
(with his/her consent) the general practitioner will be informed. The risk of
injuries during following the training program will not be higher than normal,
because people in the study will follow their regular training program. The
risk of complications in the maximal exercise test within this population
(beforehand screened on risk factors) is small. To monitor the training
program, people have to fill in a diary and give a Rate of Perceived Exertion
(RPE) score to every training session and match. Furthermore, they have to fill
in a SQUASH questionnaire about physical activity. Considering the above, we
think that the burden for participants is considered acceptable and as much
diminished as possible. The benefit for the participant is to get more insight
into their exercise capacity, the structure and function of the Achilles
tendons and vascular compliance and SAF will give an indication about the risk
for a cardiovascular disease or diabetes.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- written informed consent for study participation
- 18 yearsor older;For the different groups there will be specific inclusion criteria next to the criteria mentioned above. The competitive athletes and regularly training people have to fill in the PAR-Q questionnaire. They can only participate if they answer no to all questions. ;Competitive athletes:
- Training for more than 10 hours a week
- Performing an axial sport (involvement of components of jumping and running);regularly trained people
- Performing physical activity on a regular basis (regular is at least once a week for more than 60 min).
Control group
- Sedentary healthy people, performing physical activity that characterize sedentary behavior (1,0 - 1,5 MET (Metabolic Equivalent of Task)).;People who had a cardiovascular event and are going to follow a rehabilitation program
- People participating in a rehabilitation program in Beatrixoord
Exclusion criteria
- people not able or willing to sign informed consent
- tattoo on the lower part of the arm
- dark skin
- diabetes
- renal failure, eGFR<60
- known auto immune disease
- recent infection (<3 months) serious enough to result in hospitalisation
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 | NL58133.042.16 |