Acute Coronary SyndromeFIT@HomeNCT01732419
Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
A study testing Home-based training and Centre-based training in people with Acute Coronary Syndrome and Myocardial Infarction, run by Maxima Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- Home-based training and Centre-based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
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.
Read the 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
- Being tested
- Home-based training, Centre-based training
- Keywords
- Rehabilitation, exercise therapy, coronary artery disease
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based trainingBehavioural
Also called Homebased exercise training, Home-based cardiac rehabilitation
Home-based exercise training for cardiac patients.
Centre-based trainingBehavioural
Also called Hospital-based training, Outpatient exercise training, Centre-based cardiac rehabilitation, hospital-based cardiac rehabilitation
Usual exercise training in an outpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Home-based training | Experimental | 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. Receives: Behavioral: Home-based training |
| Centre-based training | Active comparator | 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. Receives: Behavioral: Centre-based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Fitness
Changes in peak oxygen uptake (VO2max) in mL O2/kg/min
Measured: 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: measured after 12 weeks and after one year
Secondary outcomes (3)
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).
Measured: 12 weeks
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: measured at baseline, at discharge (12 weeks), and follow-up (one year)
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: Measured at CR discharge (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H.Kemps, Maxima Medical Center
- Investigators
- Hareld Kemps, Dhr. MD., Principal investigator, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732419
- Sponsor's protocol ID
- CARDSS FIT@Home
- Acronym
- FIT@Home
- Status last verified
- Aug 2019
- First submitted
- 19 Nov 2012
- Last updated
- 29 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25354951Kraal 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.
PubMed 24103384
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT01732419
- Acronym / sponsor ID
- FIT@Home / CARDSS FIT@Home
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- Rehabilitation, exercise therapy, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Posted 29 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based training | Experimental | Behavioral: Home-based trainingAfter 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 comparator | Behavioral: Centre-based trainingPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based trainingAlso: Homebased exercise training, Home-based cardiac rehabilitationHome-based exercise training for cardiac patients. | Behavioural | Home-based training |
| Centre-based trainingAlso: Hospital-based training, Outpatient exercise training, Centre-based cardiac rehabilitation, hospital-based cardiac rehabilitationUsual exercise training in an outpatient setting. | Behavioural | Centre-based training |
Primary outcome
Physical Fitness
Time frame: Measured after 12 weeks and after one year
Changes in peak oxygen uptake (VO2max) in mL O2/kg/min
Physical Activity Level (PAL)
Time frame: measured after 12 weeks and after one year
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.
3 secondary outcomes
Training Adherence
Time frame: 12 weeks
Health Related Quality of Life
Time frame: measured at baseline, at discharge (12 weeks), and follow-up (one year)
Patient Satisfaction
Time frame: Measured at CR discharge (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25354951Kraal 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.
- Derived from this study: PubMed 24103384Kraal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hareld Kemps, Dhr. MD. principal investigator
Maxima Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based training and Centre-based training in people with Acute Coronary Syndrome and Myocardial Infarction, run by Maxima Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Fitness (time frame: Measured after 12 weeks and after one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01732419, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.