Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation (FIT@Home)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Maxima Medical Center
Sponsor:
Information provided by (Responsible Party):
H.Kemps, Maxima Medical Center
ClinicalTrials.gov Identifier:
NCT01732419
First received: November 19, 2012
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Myocardial Infarction
Behavioral: Home-based training
Behavioral: Centre-based training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation

Resource links provided by NLM:


Further study details as provided by Maxima Medical Center:

Primary Outcome Measures:
  • Physical fitness [ Time Frame: Measured after 12 weeks and after one year ] [ Designated as safety issue: No ]
    Changes in peak oxygen uptake (VO2max)

  • Physical activity energy expenditure [ Time Frame: measured after 12 weeks and after one year ] [ Designated as safety issue: No ]
    Energy expenditure is calculated by combining data from an accelerometer with data from a heart monitor, after wearing both for five days continuously.


Secondary Outcome Measures:
  • Training adherence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    training frequency, training volume and time spent within training zone will be measured in both groups

  • Health related quality of life [ Time Frame: measured after 12 weeks, 26 week and after one year ] [ Designated as safety issue: No ]
    Health-related quality of life will be assessed by the 36-Item Short Form (SF-36).


Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Behavioral: Home-based training
Home-based exercise training for cardiac patients.
Other Names:
  • Homebased exercise training
  • Home-based cardiac rehabilitation
Active Comparator: 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.
Behavioral: Centre-based training
Usual exercise training in an outpatient setting.
Other Names:
  • Hospital-based training
  • Outpatient exercise training
  • Centre-based cardiac rehabilitation
  • hospital-based cardiac rehabilitation

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732419

Contacts
Contact: Hareld Kemps, PhD, MD 0408888200 h.kemps@mmc.nl

Locations
Netherlands
Máxima Medisch Centrum Recruiting
Veldhoven, Netherlands, 5504 DB
Contact: Hareld Kemps, PhD, MD    0408888200    h.kemps@mmc.nl   
Principal Investigator: Hareld Kemps, MD, PhD         
Sponsors and Collaborators
Maxima Medical Center
Investigators
Principal Investigator: Hareld Kemps, Dhr. MD. Maxima Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: H.Kemps, MD, PhD, Maxima Medical Center
ClinicalTrials.gov Identifier: NCT01732419     History of Changes
Other Study ID Numbers: CARDSS FIT@Home
Study First Received: November 19, 2012
Last Updated: February 25, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maxima Medical Center:
Rehabilitation, exercise therapy, coronary artery disease

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014