|- candidate number||14131|
|- NTR Number||NTR3780|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-dec-2012|
|- Secondary IDs||NCT01732419 ClinicalTrials.gov|
|- Public Title||Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation.|
|- Scientific Title||Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation.|
|- hypothesis||Homebased training with telemonitoring guidance increases motivation and self-efficacy for independent exercise in Cardiac Rehabilitation patients resulting in a
more sustained increase in physical fitness and physical activity than after centrebased training. Furthermore, this strategy is associated with lower costs due to fewer
supervised exercise training sessions.|
|- Healt Condition(s) or Problem(s) studied||Acute coronary syndrome (ACS), Cardiac rehabilitation |
|- Inclusion criteria||1. Patients with an ACS (including non ST and ST elevation myocardial infarction and unstable angina) or a cardiac revascularization procedure (PCI or CABG) entering outpatient CR at Maxima Medical Center;|
2. Indication for exercise training according to the Dutch clinical algorithm for assessment of patient needs in cardiac rehabilitation;
3. Internet access and PC at home (i.e. more than 90 percent of the Dutch household).
|- Exclusion criteria||1. High risk according to the Dutch CR practice guideline;|
2. Systolic heart failure (left ventricular ejection fraction of more than 40 percent;
3. New York Heart Association class III-IV (i.e. breathlessness during light exercise or at rest);
4. Severe arrhythmia;
5. Hemodynamically significant valvular disease;
6. Implantable cardioverter-defibrillator (ICD) implantation;
7. Heart transplantation;
8. Chronic angina or silent ischemia;
9. Comorbidity impairing exercise capacity (e.g. COPD, diabetes mellitus, peripheral vascular disease and orthopedic or neurological conditions);
10. Severe psychological or cognitive impairments.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2013|
|- planned closingdate||31-dec-2014|
|- Target number of participants||90|
|- Interventions||Homebased intervention group:|
After the first three supervised training sessions in the hospitals, patients in the home-based training group are instructed to wear a heart rate monitor during exercise training at home. Prescribed exercise exists of two or three exercise sessions per week, of one hour at 70 - 85% of their maximum heart rate. Once a week the heart rate data is uploaded and evaluated by an exercise specialist together with the patient by telephone.
Centrebased control group:
Patients in the centre-based training group will perform all trainings sessions under direct supervision of a physical therapist specialized in CR. Training sessions will be performed on an cycle ergometer, starting with a warm up phase of 5 min, followed by 50 min of cycling at 70-85% of the maximal HR and a cooling down period of 5 min. During the training period, physical therapists will record attendance, training duration and actual training intensity. After the 12-week training period patients receive individual advice from their physical therapist on physical activities.
|- Primary outcome||Physical Fitness:|
Physical fitness will be assessed by peak oxygen uptake, determined by maximal exercise testing with respiratory gas analysis.
Physical Activity Energy Expenditure:
The physical activity level is assessed by physical activity energy expenditure (PAEE). To calculate PAEE, accelerometry
data (counts/min) will be combined with heart rate data.
|- Secondary outcome||Training Adherence:|
training frequency, training volume and time spent within training zone will be measured in both groups.
Health related quality of life:
Health-related quality of life will be assessed by the 36-Item Short Form (SF-36).
|- Timepoints||Primary and secondary outcomes will be assessed before the start of the training sessions, after the cardiac rehabilitation (12 weeks) and after one year (52 weeks).|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Hareld M.C. Kemps|
|- CONTACT for SCIENTIFIC QUERIES|| Hareld M.C. Kemps|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Physical exercise training appears effective for low to moderate patients assigned to cardiac rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity levels often drop after attending the last rehabilitation session.
This study will compare home based physical exercise training including telemonitoring with regular centre based physical exercise training. Main outcome measures are the change in physical activity and the change physical fitness after the rehabilitation and after 1 year. Secondary outcome measures are cost-effectiveness of both types of cardiac rehabilitation, training adherence, health-related quality of life and patient satisfaction.
|- Main changes (audit trail)|
|- RECORD||21-dec-2012 - 16-jan-2013|