The main objective of the study is to investigate the physiological effects of high intensity interval training (HIT) at the skeletal muscle level by assessing skeletal muscle re-oxygenation, skeletal muscle metabolic recovery and re-oxygenation…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in skeletal muscle metabolic recovery after submaximal exercise (leg
extension in the supine position) are assessed by 31P MR spectroscopy
measurements in M. vastus lateralis (rate of post-exercise phosphocreatine
increase, expressed as * -PCr). Changes in skeletal muscle re-oxygenation are
assessed simultaneously at the same location by Near Infrared Spectroscopy
(rate of post-exercise decrease in deoxygenated hemoglobin, expressed as
MRT-HHb). Changes in physiological aspects of skeletal muscle oxygenation and
metabolism are assessed by oxidative enzyme activity (succinate dehydrogenase
and cytochrome-C-oxidase activity), muscle fibre type distribution and
capillary density.
Secondary outcome
Changes in maximal exercise capacity (peak Vo2) and submaximal exercise
capacity (rate of recovery of oxygen uptake and re-oxygenation after submaximal
exercise), left ventricular function (left ventricular ejection fraction and
end systolic volume) and Quality of life (Minnesota living with heart failure
questionnaire).
Background summary
Patients with chronic heart failure (CHF) suffer from exercise intolerance,
mainly due to a decreased cardiac output and impaired skeletal muscle function.
Exercise training can improve their functional capacity and reduce their
symptoms. To date, it remains unclear what the optimal intensity of exercise
should be. A recent randomized controlled trail in elderly CHF patients showed
a dramatic gain in exercise capacity using high intensity interval training
(HIT) as compared to training at a moderate intensity. This study showed
improvements in skeletal muscle metabolism, blood flow and cardiac function.
However, as all these measurements were performed at rest it is not clear to
what extent these changes account for the increase in exercise performance.
Yet, such knowledge is necessary for individualized exercise prescription,
specifically aimed at the individual patients* limitations.
The present study is designed to investigate the effects of HIT on skeletal
muscle metabolism (O2 utilization) and oxygenation (O2 delivery) at submaximal
exercise.
Study objective
The main objective of the study is to investigate the physiological effects of
high intensity interval training (HIT) at the skeletal muscle level by
assessing skeletal muscle re-oxygenation, skeletal muscle metabolic recovery
and re-oxygenation after submaximal exercise, oxidative capacity, capillary
density and muscle fibre type distribution. Secondary objectives are to
investigate the effects of HIT on maximal and submaximal exercise capacity,
quality of life and left ventricular function.
Study design
Prospective semi-crossover randomised controlled intervention trial.
Intervention
HIT is performed 3 times a week during 12 weeks and consists of 4 intervals of
4 minutes cycling on a ergometer at 85-95% of the peak aerobic capacity (peak
Vo2) separated by 3 minute active pauses at 50-60% of peak Vo2. The entire
program is performed in the hospital under direct supervision of trained
physiotherapists. Patients in the control group will participate in the
training program after completion of the control period of 12 weeks.
Study burden and risks
No adverse effects of exercise training performed by CHF patients have been
reported in literature, nor in our clinical experience. Yet, exercise training
was shown to have beneficial effects on maximal exercise capacity, muscle
strength and quality of life. The HIT program that will be used in this study
has been evaluated extensively in CHF patients and other populations, like
elderly patients, and patients with coronary artery disease without any
documented harmful effects. In order to reduce potential risks of exercise
training, all patients perform a maximal cardiopulmonary exercise test at
baseline, excluding patients with myocardial ischaemia and ventricular
arrhythmias during exercise. Training sessions will be under supervision of
trained physiotherapist in a clinical setting.
The assessments that will be done before and after training are completely
non-invasive except for sampling of muscle tissue. 31P magnetic resonance
spectroscopy measurements are exclusively performed in patients without
pacemaker / implantable cardioverter defibrillator (ICD) or other contra
indication for magnetic resonance imaging. The muscle biopsy procedure is
performed in a subgroup of 28 patients and has a complication risk that is
considered to be very low. By performing these measurements, we will be able
to evaluate the physiological effects of HIT. This knowledge may eventually be
useful for a more individualized exercise prescription, specifically aimed at
the patients* individual limitations.
de Run 4600
Postbus 7777 5500 MB Veldhoven
NL
de Run 4600
Postbus 7777 5500 MB Veldhoven
NL
Listed location countries
Age
Inclusion criteria
Written informed consent
Stable systolic heart failure secondary to ischemic or dilated cardiomyopathy
New York Heart Association (NYHA) class II or III (without change in class or medication < 3 months prior to inclusion)
Left ventricular ejection fraction of * 40% (assessed within 3 months before inclusion by echocardiography, MRI or radionuclear measurement)
Exclusion criteria
Myocardial infarction or unstable angina less than 3 months prior to inclusion
Clinical signs of decompensated heart failure
Ventricular tachycardia or ischemia during exercise
Participation in a training program (* 2/week) in the last year
Intracardiac shunts or congenital heart disease limiting exercise capacity
Orthopaedic, vascular, pulmonary, neuromuscular and other disease limiting exercise capacity
MRI will not be a part of the study protocol in eligible patients with pacemaker / implantable cardioverter defibrillator (ICD) or other contra indication for magnetic resonance imaging
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL33837.015.10 |
| OMON | NL-OMON22308 |