Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation

Myocardial Infarction Clinical Trial

— FIT@Home  

Official title:

Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732419
• Other study ID #: CARDSS FIT@Home
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: August 2019
• Source: Maxima Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Home-based training
Home-based exercise training for cardiac patients.
• Centre-based training
Usual exercise training in an outpatient setting.

Locations

Country	Name	City	State
Netherlands	Máxima Medisch Centrum	Veldhoven

Sponsors (1)

Lead Sponsor	Collaborator
Maxima Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Fitness	Changes in peak oxygen uptake (VO2max) in mL O2/kg/min	Measured after 12 weeks and after one year
Primary	Physical Activity Level (PAL)	PAL is calculated by combining data from an accelerometer with data from a heart monitor, after wearing both for five days continuously. To determine PAL, physical activity energy expenditure is divided by resting metabolic rate, calculated by the Harris-Benedict equation. PAL expressed a person's daily energy expenditure. When PAL is used to classify the intensity of an activity, PAL<3, PAL<6 and PAL>6 are characterized as light, moderate and vigorous intensity activities respectively. An average daily PAL of 1.2 represents the activity level of a bed-bound subject, while the average PAL for the adult population is 1.7.	measured after 12 weeks and after one year
Secondary	Training Adherence	Provides information on the average amount of training sessions were performed during the 12 week cardiac rehabilitation program. Both groups received the advice to train at least 2 times a week for 12 weeks (thus 24 sessions).	12 weeks
Secondary	Health Related Quality of Life	Health-related quality of life will be assessed by the MacNew questionnaire. The items and scale are scored from 1 (low health-related Quality of Life) to 7 (High health-related Quality of Life).	measured at baseline, at discharge (12 weeks), and follow-up (one year)
Secondary	Patient Satisfaction	Patient satisfaction is measured directly after CR discharge (12 weeks) using the Consumer Quality Index, a standardized survey method combining the inventory of patient experiences with an assessment of their priority. Results are provided on a scale of 1 (very low satisfaction) to 10 (very high satisfaction).	Measured at CR discharge (12 weeks)