N/A
N=90
Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
Acute Coronary Syndrome · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT01732419 ↗Enrolled (actual)
90
Serious AEs
13.3%
Results posted
Aug 2019
Primary outcome: Primary: Physical Fitness — 24.4; 24.0; 27.9; 26.5 ml O2/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home-based training (Behavioral); Centre-based training (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Maxima Medical Center
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Fitness |
24.4; 24.0; 27.9; 26.5; 27.7; 27.5 | — |
| PRIMARY Physical Activity Level (PAL) |
2.09; 1.95; 2.22; 2.38; 2.14; 2.13 | — |
| SECONDARY Training Adherence |
22.0; 20.6 | — |
| SECONDARY Health Related Quality of Life |
5.62; 5.45; 6.00; 5.90; 5.75; 5.43 | — |
| SECONDARY Patient Satisfaction |
8.7; 8.1 | — |
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 supervised 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 in physical fitness (peak Oxygen uptake) after the initial rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are cost-effectiveness, training adherence, health-related quality of life and patient satisfaction.
Eligibility Criteria
Inclusion criteria
- 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.
- Indication for exercise training according to the Dutch clinical algorithm for assessment of patient needs in cardiac rehabilitation.
- Internet access and PC at home (i.e. more than 90 percent of the Dutch household)
Exclusion criteria
- High risk according to the Dutch CR practice guideline.
- Systolic heart failure (left ventricular ejection fraction of more than 40 percent.
- New York Heart Association class III-IV (i.e. breathlessness during light exercise or at rest).
- Severe arrhythmia.
- Hemodynamically significant valvular disease.
- Implantable cardioverter-defibrillator (ICD) implantation
- Heart transplantation.
- Chronic angina or silent ischemia.
- Comorbidity impairing exercise capacity (e.g. COPD, diabetes mellitus, peripheral vascular disease and orthopedic or neurological conditions).
- Severe psychological or cognitive impairments.
Data sourced from ClinicalTrials.gov (NCT01732419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.