Clinical trial NCT01732419: Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
Official title: Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Keywords: Rehabilitation, exercise therapy, coronary artery disease
Lead sponsor: Maxima Medical Center
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Detailed description: Physical training has beneficial effects on exercise capacity, cardiac function, quality of life and mortality in patients with acute cardiovascular syndrome or after cardiac surgery and is therefore one of the main aspects of cardiac rehabilitation. However, adherence to this therapy is low and effects tempt to decrease directly after the treatment period.

The objective of this study is to compare the effects of home-based exercise training (HT) with telemonitoring guidance and regular centre-based exercise training (CT) on physical fitness (PF), assessed by peak oxygen uptake, and physical activity (PA), assessed by physical activity energy expenditure (PAEE), in low to moderate risk cardiac rehabilitation (CR) patients. Secondary endpoints are cost-effectiveness, training adherence, health-related quality of life (QoL) and patient satisfaction.

Single-centre randomized controlled trial. CR patients are randomized to HT (n=45) or CT (n=45). Assessments are performed at baseline, 12 weeks and 1 year, consisting of maximal exercise testing with respiratory gas exchange analysis, assessment of PAEE, QoL (also at 6 months), patient satisfaction (at 12 weeks only) and health care costs (12 weeks, 6 months and 1 year) Study population: Low to moderate risk patients entering outpatient CR after an acute coronary syndrome or revascularization with internet access and PC at home.

12-week training program (24-36 one-hour sessions) at 70-85% of their maximal heart rate (HR). In the CT group training is supervised by a physical therapist; in the HT group training is performed in the home environment using a HR monitor to determine training intensity and with weekly feedback / motivation by an exercise specialist who has access to the online HR-data. After 12 weeks, subjects in the HT group are encouraged to continue using the HR monitor.

Main study parameters/endpoints: Primary endpoints: PF (peak oxygen uptake) and PA (physical activity energy expenditure, PAEE) assessed by a tri-axial accelerometer and HR monitor. Secondary endpoints: training adherence, QoL (SF-36) and patient satisfaction (CQ index).

Exercise training performed by patients after Acute Coronary Disease (ACS) and revascularization, classified as low to moderate risk, is considered to be safe. The training program that will be used in this study has been evaluated in a similar population of elderly cardiac patients 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. The first three training sessions will be under supervision of trained physiotherapist in a clinical setting. The patients will receive a heart rate monitor and accelerometer to use at home. These monitors are developed and optimized to cause minimal physical discomfort and are non-invasive. During the measurement periods, all patients are asked to wear the monitors continuously for 5 days and to note the physical activities performed. The HT group will use the HR monitors during their physical trainings as well.

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.

Primary outcomes:
measure: Physical Fitness
timeFrame: Measured after 12 weeks and after one year
measure: Physical Activity Level (PAL)
timeFrame: measured after 12 weeks and after one year
Secondary outcomes:
measure: Training Adherence
timeFrame: 12 weeks
measure: Health Related Quality of Life
timeFrame: measured at baseline, at discharge (12 weeks), and follow-up (one year)
measure: Patient Satisfaction
timeFrame: Measured at CR discharge (12 weeks)
Other outcomes:
Locations:
city: Veldhoven
country: Netherlands
facility: Máxima Medisch Centrum
Study officials:
affiliation: Maxima Medical Center
name: Hareld Kemps, Dhr. MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraal JJ, Peek N, Van den Akker-Van Marle ME, Kemps HM. Effects of home-based training with telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation: short-term results of the FIT@Home study. Eur J Prev Cardiol. 2014 Nov;21(2 Suppl):26-31. doi: 10.1177/2047487314552606.
citation: Kraal JJ, Peek N, van den Akker-Van Marle ME, Kemps HM. Effects and costs of home-based training with telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation: The FIT@Home study. BMC Cardiovasc Disord. 2013 Oct 8;13:82. doi: 10.1186/1471-2261-13-82.