Determine the prolonged effect of a 12 week physical exercise program in congestive heart failure patients.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement of the functional capacity and to determine the prolonged effects
of this intervention.
Secondary outcome
Secundairy endpoints are:
Serum levels of NT-proBNP
serum levels of CRP
Quality of live (assessed with MLHFQ)
Glycocalyx thickness measured with SDF.
Left ventricular ejection fraction
Background summary
Physical exercise has been shown to improve the functional capacity and the
quality of life in patients with congestive heart failure. Currently it is
unknown if physical exercise therapy has a prolonged beneficial effect in these
patients. However, to implement physical exercise therapy as a treatment
modality in the clinical care of congestive heart failure patients it is
crucial to establish if there is a prolonged effect of this intervention. If
so, exercise therapy would probably be feasible and cost-effective.
Study objective
Determine the prolonged effect of a 12 week physical exercise program in
congestive heart failure patients.
Study design
an open randomized prospective clinical trial.
Intervention
12 week physiotherapist guided exercise program
Study burden and risks
Patinets randomised to the exercise group will follow an intensive exercise
program of 12 weeks, with 2 sessions a week for 90 minutes
Addiotional patients will visit the outpatient clinic of the OLVG for 4 times
for the following investigations:
venapuncture
Quality of life assessment
physical examination
cardiac ultrasound
SDF measurement
Sic minute walking test
Oosterpark 9
1091 AC Amsterdam
Nederland
Oosterpark 9
1091 AC Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria p 10
* Symptomatic systolic heart failure (documented clinical signs and symptoms of heart failure) documented for more than 3 months.
* Left ventricular ejection fraction (EF) less than 40% estimated by 2D echocardiography.
* New York Heart Association (NYHA) class: II and III.
* Age between 18- 80 years
* Clinically stable with regard to symptoms and optimal medical therapy for more than 2 weeks prior to inclusion.
Exclusion criteria
exclusion criteria p 11
* Orthopedic, peripheral vascular or neurological disease limiting the ability to exercise
* Documented exercise-induced ischemia
* Documented exercise-induced ventricular tachycardia
* Poorly controlled cardiac arrhythmias
* Significant chronic pulmonary disease limiting the ability to exercise
* Uncontrolled hypertension
* Abnormal blood pressure response to exercise testing (systolic blood pressure >250 mmHg or diastolic blood pressure >120 mmHg.) Or blood pressure drop of > 20mmHg during baseline exercise test.
* Major anemia
* Aortic valve stenose
* Co morbidity that contraindicate exercise
* Terminal disease
* Patients who can*t speak/understand or read the Dutch language
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2009-010476-22-NL |
| CCMO | NL21370.100.09 |