Primary objective: To compare the impact of a single day of prolonged walking exercise on cardiac function and biomarker responses between heart failure patients and their age- and sex-matched controls.Secondary objective: To compare the impact of 1…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Left ventricular ejection fraction, E/E* ratio and global longitudinal strain,
RV fractional area change, E/E* ratio and global longitudinal strain are the
primary outcome parameters in this study.
Secondary outcome
Cardiac biomarkers (high-sensitivity cardiac troponin, NT-proBNP, Galectin 3
and ST2) and pulse wave velocity will be included as secondary outcome
parameters
Background summary
Walking represents moderate-intensity exercise which can be performed for
several hours. This makes (prolonged) walking exercise an effective strategy to
improve physical fitness and to attenuate the development / progression of
cardiovascular diseases. Previous studies indicated that a physical active
lifestyle can improve longevity and reduce the risk for future cardiovascular
events in various clinical populations. Accordingly, walking exercise is
frequently prescribed by physicians, resulting in the participation of patients
with cardiovascular diseases (e.g. heart failure, myocardial infarction,
coronary artery disease, etc.) in walking events like the Nijmegen Four Days
Marches.
Prolonged exercise is known to cause an acute, but transient, impairment in
cardiac function in healthy young populations. Previous studies reported
reductions in ejection fraction and systolic/diastolic dysfunction following
endurance exercise, which is referred to as *cardiac fatigue*. Whether these
exercise-induced responses are also present in heart failure patients, who
demonstrate an a priori impaired cardiac function, is currently unknown.
Study objective
Primary objective: To compare the impact of a single day of prolonged walking
exercise on cardiac function and biomarker responses between heart failure
patients and their age- and sex-matched controls.
Secondary objective: To compare the impact of 1-day versus multiple days of
prolonged walking exercise on cardiac function and biomarker responses in heart
failure patients and age- and sex-matched controls.
Study design
An observational study in which the cardiac function will be examined before
and immediately after the 1st and 3rd day of the Nijmegen Four Days Marches in
20 participants. Blood samples for cardiac biomarker analysis will be obtained
at baseline, and after day 1, 2, 3 and 4 of the Nijmegen Four Days Marches.
Study burden and risks
Walking is not associated with serious health risks. Actually, regular physical
activity such as walking exercise protects against cardiovascular disease/risk.
Furthermore, our primary outcome measures relate to non-invasive measurement of
cardiac function. Our secondary outcome measures will be determined from a
venous blood sample (i.e. cardiac biomarkers). This procedure is associated
with a minor risk for haemorrhage (5%).
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
Heart failure group
- Participant of the Nijmegen 4-Day Marches 2014
- >=18 years
- Mentally able/allowed to give informed consent
- Patients diagnosed with systolic heart failure (including an ejection fraction <50% on current medication)
- NYHA class 1 + II;Control group
- Participant of the Nijmegen 4-Day Marches 2014
- >=18 years
- Mentally able/allowed to give informed consent
Exclusion criteria
Heart failure group
- NYHA class III + IV
- Ejection fraction <25%;Control group
- Subjects diagnosed with the following cardiovascular diseases:
o Congenital heart disease
o Myocardial infarction
o Cerebrovascular incident
o Cerebral infarction
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 | NL48730.072.14 |