Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
FIT@Home
Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2012
CompletedFirst Posted
Study publicly available on registry
November 22, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
August 29, 2019
CompletedAugust 29, 2019
August 1, 2019
2.7 years
November 19, 2012
October 24, 2017
August 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Physical Fitness
Changes in peak oxygen uptake (VO2max) in mL O2/kg/min
Measured after 12 weeks and after one year
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 Outcomes (3)
Training Adherence
12 weeks
Health Related Quality of Life
measured at baseline, at discharge (12 weeks), and follow-up (one year)
Patient Satisfaction
Measured at CR discharge (12 weeks)
Study Arms (2)
Home-based training
EXPERIMENTALAfter 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.
Centre-based training
ACTIVE COMPARATORPatients 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.
Interventions
Home-based exercise training for cardiac patients.
Usual exercise training in an outpatient setting.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Máxima Medisch Centrum
Veldhoven, 5504 DB, Netherlands
Related Publications (2)
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.
PMID: 25354951DERIVEDKraal 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.
PMID: 24103384DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
blinding of patients due to nature of the study protocol
Results Point of Contact
- Title
- Dr. J. Kraal
- Organization
- Maxima Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Hareld Kemps, Dhr. MD.
Maxima Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
November 19, 2012
First Posted
November 22, 2012
Study Start
January 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
August 29, 2019
Results First Posted
August 29, 2019
Record last verified: 2019-08