To examine the impact of walking training on the lifetime risk for cardiovascular disease in DMT2 and DMT1 patients and to assess whether these effects are preserved 3 months after the Nijmegen 4-Day marches. Results will be compared with a control…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Diabetic complications
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lifetime risk score for cardiovascular disease
Secondary outcome
not applicable
Background summary
Diabetes mellitus type 1 (DMT1) and type 2 (DMT2) represent a major health
problem in the Western society. Physical inactivity plays a detrimental role in
the development of DMT2, whilst physical inactivity also contributes to the
increased risk for future cardiovascular events and vascular complications in
DMT1 and DMT2. To support this notion, exercise training has various beneficial
effects, including decreasing the cardiovascular risk in DMT1 and DMT2.
Nonetheless, exercise training in a gym-based setting is associated with low
motivation to continue an active life style. Walking exercise represents an
attractive type of exercise that can be performed everywhere. Moreover,
performing exercise training in preparation for an event (such as the Nijmegen
4-Day Marches) is associated with a clear goal and may therefore enhance
motivation to adopt an active life style and to remain physically active. These
changes in life style are believed to contribute to a lower risk for future
cardiovascular risk in those patients. The purpose of this study is to examine
the impact of walking exercise training in DMT1 and DMT2 on the lifetime risk
for cardiovascular disease, but also whether subjects remain physically active
after finishing the Nijmegen 4-Day marches.
Study objective
To examine the impact of walking training on the lifetime risk for
cardiovascular disease in DMT2 and DMT1 patients and to assess whether these
effects are preserved 3 months after the Nijmegen 4-Day marches. Results will
be compared with a control group of non-exercising DMT2 and DMT1 patients
Study design
Subjects will undergo 3-months of walking exercise and take part in walking
training program.
Intervention
Walking exercise (ViaVierDaagse)
Study burden and risks
To calculate the lifetime risk score, subjects undergo a number of measurements
for body characteristics (10 minutes; e.g. height, weight, blood pressure),
fill in a questionnaire (5 minutes) and subjects will undergo blood withdrawal
(5 minutes; cholesterol, glucose, insulin). Finally, to calculate the lifetime
risk score subjects also undergo a submaximal cycling test (*strand test) to
estimate the maximal oxygen consumption (30 minutes). This set of experiments
(50min in total) will be performed before, immediately after, and at 3 months
after the walking training (3 times 50min).
Subjects will perform walking exercise training. This type of exercise training
is safe, and not associated with any health risk. Although walking training
will be performed under home-based conditions, regular feedback will be
provided and clear instructions will be provided (written and orally) about
potential risks of walking exercise (injuries, but also the risk for
hypoglycaemia). Feedback and information will be provided by Prof. Dr Cees Tack
from the Department of Internal Medicine from the UMC St Radboud. The
Department of Physiology has a long and strong history of performing exercise
training studies in healthy volunteers (children, adolescents, middle-aged and
older subjects) as well as various patient groups (including DMT1 and DMT2).
Taken together, our study involves minimally and non-invasive measures, whilst
our intervention is believed to have a strong and potent health benefit for
DMT1 and DMT2 patients and will gain important and novel information about the
impact of exercise training in DMT1 and DMT2 patients.
Geert Grooteplein-noord 21
6525 EZ Nijmegen
NL
Geert Grooteplein-noord 21
6525 EZ Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with type 2 diabetes mellitus (type 2 diabetes patients only)
- Diagnosed with type 1 diabetes mellitus (type 1 diabetes patients only)
- Mentally and physically capable to perform exercise training (type 1 and 2 diabetes)
- Age >18 year
Exclusion criteria
- Subjects with vascular complications due to type 1 and 2 diabetes mellitus (e.g. diabetic foot ulcer, foot ulcers as a consequence of polyneuropathology or foot ulcers of any other cause)
- Presence of an absolute contra-indication for the performance of exercise (SOP inspanningstest, department of physiology)
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 | NL40101.091.12 |