Randomized Clinical Trial for optimal Cardiac Rehabilitation: A traditional Dutch Cardiac Rehabilitation Program versus a Canadian High Efficiency Cardiac Rehabilitation Program

Cardiovascular diseases (CVDs) are the leading cause of death and a major cause
of disability and loss of productivity in adults worldwide. In the Netherlands,
the substantial burden of CVD is further exemplified by an estimated 45%
increase of the number of patients with CVD from 2000-2020. Compliance after
cardiac rehabilitation, which is generally limited to 12 weeks, is found to be
relatively low and less than half of the patients continue their physical
training after initial rehabilitation. The *HoogRendement HartRevalidatie*
(HR)2 is a method of cardiac rehabilitation based on the highly successful
Cardiac Rehabilitation Program from Toronto. The Canadian program helps people
with heart diseases to improve their fitness and strength, and, importantly,
helps them to reduce their chance of future heart problems by making
long-lasting lifestyle changes. It has been shown that only 6.2% of patients
that underwent the Toronto cardiac rehabilitation program required
rehospitalization within 10 years, which is in major contrast with the 44% of
rehospitalization within 5 years in the Netherlands. In a recent study it was
demonstrated that 52-weeks of combined supervised and unsupervised exercise
sessions was effective in improving both physical and mental health, with the
peak observed at 38 weeks (~nine months). It was suggested that further
economies of cost might be realized by introducing progressive tapering of
supervision. This study will be carried out at request of the the Ministry of
Health, Welfare and Sport (VWS).

To assess the suitability of the (HR)2 programme in the Dutch setting and
compare the efficiency of the (HR)2 programme with traditional cardiac
rehabilitation in the Netherlands.

Randomized controlled interventional pilot study

Patients in the (HR)2 program will undergo 18 months of an individually
tailored exercise training, i.e. walking and jogging at a moderate intensity.
The outcomes of the maximal exercise tests will enable to personalize the
exercise program that best meets the condition and abilities of the patient.
Participants will undergo 5 hourly exercise sessions/week of walking/jogging
at moderate intensity. During the first 9 months of the program one weekly
session will be supervised (1 hour exercise, 1 hour education lifestyle). In
the last 9 months, one monthly session will be supervised (1 hour exercise, 1
hour education lifestyle). The other exercise sessions will be performed in the
home environment of the patient. The education sessions aim to stimulate a
healthy lifestyle, focusing on risks, medications, exercise, stress and healthy
eating habits. Cardiac patients that are randomized to the other intervention
group will undergo 3 months of traditional cardiac rehabilitation, according to
the Dutch guidelines.

Noninvasive vascular and cardiac testing procedures in this study are not
related to any potential risk for the participant. Headache and dizziness of
short duration may occur following nitroglycerin spray. Although inflation of
the blood pressure cuff during the vascular measurements may induce a slight
uncomfortable sensation, this is brief (5 minutes) and stops when the cuff is
deflated. Maximal cycling tests will be performed at the hospital under
supervision of highly qualified personnel.
A possible complication of venipuncture is a hematoma, which is induced in ~5%
of all cases. To prevent complications, the blood withdrawal will be performed
by an experienced professional and sufficient pressure will be provided after
withdrawal of the needle.
Patients in the (HR)2 program will undergo 18 months of an individually
tailored exercise training, i.e. walking and jogging at a moderate intensity (5
hourly sessions/week). This type of exercise training is safe, and exercise
sessions will be supervised on a regular basis. Education will be a key
component of the program to stimulate a healthy lifestyle, focusing on risks,
medications, exercise, stress and healthy eating habits. To date, more than
50,000 cardiac patients have successfully participated in the Cardiac
Rehabilitation Program from Toronto, where the current (HR)2 program is based
on. Patients in the other group will undergo 3 months of traditional cardiac
rehabilitation, according to the Dutch guidelines.
Taken together, this study involves minimally and non-invasive measures, whilst
the (HR)2 program is believed to have a strong and potent health benefit for
cardiac patients, and may eventually result in important economic benefits. The
results of this study will gain important information about the suitability of
the (HR)2 program in the Netherlands.