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

NCT ID: NCT01732419

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home-based training

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.

Group Type: EXPERIMENTAL

Home-based training

Intervention Type: BEHAVIORAL

Home-based exercise training for cardiac patients.

Centre-based training

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.

Group Type: ACTIVE_COMPARATOR

Centre-based training

Intervention Type: BEHAVIORAL

Usual exercise training in an outpatient setting.

Interventions

Home-based training

Home-based exercise training for cardiac patients.

Intervention Type: BEHAVIORAL

Centre-based training

Usual exercise training in an outpatient setting.

Intervention Type: BEHAVIORAL

Other Intervention Names

Homebased exercise training; Home-based cardiac rehabilitation; Hospital-based training; Outpatient exercise training; Centre-based cardiac rehabilitation; hospital-based cardiac rehabilitation

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maxima Medical Center

OTHER

Sponsor Role: lead

Responsible Party

H.Kemps

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hareld Kemps, Dhr. MD.

Role: PRINCIPAL_INVESTIGATOR

Maxima Medical Center

Locations

Máxima Medisch Centrum

Veldhoven, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 25354951 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24103384 (View on PubMed)

Other Identifiers

CARDSS FIT@Home

Identifier Type: -

Identifier Source: org_study_id