The primary goal is to compare the physiological stress and strain of the fluid- and electrolyte balance and thermoregulation between participants of the Nijmegen 4-Day Marches that are hypertensive and use diuretics, and a group of healthy,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Inspannings gerelateerde gezondheidsrisico's (o.a. vocht- en electrolytenbalans, thermoregulatie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Fluid intake and urine output
2) Blood determinations (lipid profile, electrolytes, hematocrit, hemoglobine,
creatine kinase, troponin)
3) Core body temperature, skin temperature and heart rate
4) Energy expenditure
5) Personal characteristics (questionnaire)
6) Ambient conditions (WBGT)
Secondary outcome
1) Urine analysis
2) Blood vessel quality (IMT of the a. carotis)
3) General characteristics
4) Blood pressure
Background summary
Elevated blood pressures (hypertension) have a major impact on health. After
all, hypertension is a primary risk factor for the development of
cardiovascular diseases, the leading death cause in the Netherlands. Although
physical activity is an important risk factor in the development of
hypertension, we showed in previous studies that the prevalence of hypertension
in participants of the Nijmegen Marches is comparable with the general Dutch
population. A questionnaire in 5000 participants of the Nijmegen Marches
revealed that 20% of the subjects had elevated blood pressures or used blood
pressure related medication. Besides that diuretics are the primary
intervention in the management of hypertension, this type of medication also
interacts with the fluid- and sodium balance. The incidence of dehydration in
our previous studies was 25%, and can cause an impaired physical performance
and an increased risk to develop heat related illnesses. Therefore subjects
with hypertension that use diuretics, may be prone to fluid disturbances and
consequent health risks. However, little is known regarding the effect of
diuretics on fluid- and electrolyte balance in participants of endurance
exercise events.
Study objective
The primary goal is to compare the physiological stress and strain of the
fluid- and electrolyte balance and thermoregulation between participants of the
Nijmegen 4-Day Marches that are hypertensive and use diuretics, and a group of
healthy, normotensive, age and gender matched control subjects.
Study design
Observational study
Study burden and risks
In addition to a questionnaire, heart rate monitor, activity monitor, skin
thermometer (subgroup), food and fluid diary and determination of body weight,
subjects receive a sensor pill that record core body temperature. The latter
assessment is a safe, valid and 'friendly' method to record core body
temperature. Furthermore blood and urine will be taken to gain insight into the
fluid and electrolytebalance.The burden of these tests are, physical as well as
in time, minimal and privide important information which is necessary for the
primary aim of the study.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- older than 18 years
- Group 1: participant of 4-Day marches / healthy subjects, normotensive
- Group 2: participant of 4-Day marches / hypertesion in combination with the use of diuretics
Exclusion criteria
obstructive disease of the gastro-intestinal tract, including diverticulitis and inflammatory bowel disease
- previous gastrointestinal surgery, except cholecystectomy and appendectomy
- MRI during the period that the CorTemp sensor is within the body (e.g. 1 day preceding the 4-Day Marches, during the 4-Day Marches and 2 days after the the 4-Day Marches)
- subject having a cardiac pacemaker or other implanted electromedical device;Additional exclusion criteria for group 1:
- the use of medicaments that interfere with the fluid balance
- the use of medicaments that interfere with the electrolyte balance
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 | NL32574.091.10 |