Coronary Artery DiseaseNCT03228225
Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1
A study testing Tele Cardiac Rehabilitation in people with Coronary Artery Disease, run by Sheba Medical Center at 1 site in Israel.
Trial summary
We aim to enroll subjects eligible to cardiac rehabilitation that are defined as low-risk according to national guidelines. We plan to gradually reduce the number of institution based CR and increase the tele monitored exercise sessions performed in the community. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Tele Cardiac Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary disease (S/p ACS, PCI, CABG or stable angina with documented coronary disease)
- Age ≥ 21
- Smartphone with internet connection
- Willing and able to comply with study protocol and
- LVEF > 40% and Baseline METS ≥ 5
- Able to follow the personalized exercise prescription, utilize smartwatch and upload exercise data per protocol
Who cannot join
- Heart failure (clinical) or unresolved significant arrhythmia (i.e. symptomatic atrial fibrillation)
- Significant neurological or cognitive impairment
- Women of child-bearing potential
- Symptomatic hypotension, orthostatic hypotension or repeated blood pressure systolic value <100 mmHg without symptoms
- ACS or percutaneous coronary intervention (PCI) within 30 days prior to screening, or having undergone CABG surgery within 30 days prior to screening
- Inability to perform a CPET test due to physical limitations
Show all 15Show fewer
- Ischemia per stress test \ nuclear scan or stress echocardiography
- Severe angina pectoris as defined by CCS >2
- Pulmonary disease of severity greater than mild (COPD, Asthma, ILD, CTD with lung involvement) or chronic pulmonary thromboembolic disease (CTED)
- Severe orthopedic limitations
- Active myocarditis, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy
- Moderate or severe Aortic or Mitral stenosis, moderate or severe mitral regurgitation due to primary valvular disease
- Significant anemia (Hb <10 mg/dl)
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
- Any illness which reduces life expectancy to less than 1 year from screening
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Robert Klempfner, Prof.
robert.klempfner@sheba.health.gov.il
About this study
We aim to enroll subjects eligible to cardiac rehabilitation that are defined as low-risk according to national guidelines. We plan to gradually reduce the number of institution based CR and increase the tele monitored exercise sessions performed in the community. Stress test will be preformed before the intervention and after completing 6 month.
Read the detailed description
Following the standard rehabilitation intake process (physician visit, nurse intake, exercise physiologist consultation based on stress test and clinical data passed from the physician) all subjects will begin their secondary prevention program including on-site supervised training, nurse case management, plus dietitian and psychological consultation as necessary. During the study weeks subjects will wear the smartwatch (Polar Inc.) in order to collect de-identified data (heart rate, step count, walk speed etc.) and will upload data to the Polar cloud. No medical data will be uploaded and subjects will only have a coded ID randomly generated. During the exercise periods (both on-site in the cardiac rehabilitation institute, and also during the recommended community exercise performed on their own).
Gradually, the number of on-site sessions will decrease from the standard of 8 sessions per month to zero (each month after the first a reduction of 2 sessions). We plan to reduce the on-site sessions while increasing the number of home-based session in order to evaluate the ability to monitor, coach and dynamically adjust the exercise program by combined use of smartwatch data and telephone contact. Polar exercise watch will be provided and appropriate operation instructions and education will be given after informed consent.
During the 6 month study period we will contact subjects once or twice weekly in order to encourage participation, fine-tune the exercise program and to assess secondary prevention goals.
All subjects will undergo a stress test before and after 6 months of training part of the standard of care management, as well as dietitian, physician and psychologist consultations will be offered following the regular schedule of the standard rehabilitation program (at baseline, 3 months and 6 months).
- Conditions
- Coronary Artery Disease
- Being tested
- Tele Cardiac Rehabilitation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele Cardiac RehabilitationBehavioural
Comprehensive intervention according to the secondary prevention goals
| Study group | Role | What they receive |
|---|---|---|
| Tele cardiac rehabilitation | Experimental | Following a standard intake process, patients will begin exercise in the institute and will gradually over a period of 6 months reduce the number of institution visits and will concomitantly increase the number of home \ community exercise sessions. During the entire period we will monitor program, coach and fine-tune the exercise program. Weekly exercise data will be securely transmitted to the rehabilitation team (heart rate zones, duration of exercise and type, step count, caloric expenditure, blood pressure and patients reported impressions) Receives: Behavioral: Tele Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Stress bases METS assessment
Measured: 6 months
Secondary outcomes (4)
Subject satisfaction
Questioner based assessment of program
Measured: 3 and 6 months
Adherence to exercise program
Amount of time exercising at the specified target heart rate zone per week
Measured: 3 and 6 months
Quality of life
QOL questioners
Measured: 3 and 6 months
Device ease of use and technical difficulties
Questioners and transmission failures or usability issues
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Nov 2017
- Primary completion20 Jul 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- single arm non-blinded remote monitored multidisciplinary secondary prevention intervention
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Robert Klempfner Heart Rehabilitation Institute, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228225
- Sponsor's protocol ID
- SMC-17-4154
- Status last verified
- Jun 2018
- First submitted
- 17 Jul 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1
- ClinicalTrials.gov ID
- NCT03228225
- Acronym / sponsor ID
- SMC-17-4154
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 20 Jul 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to enroll subjects eligible to cardiac rehabilitation that are defined as low-risk according to national guidelines. We plan to gradually reduce the number of institution based CR and increase the tele monitored exercise sessions performed in the community. Stress test will be preformed before the intervention and after completing 6 month.
Detailed description
Following the standard rehabilitation intake process (physician visit, nurse intake, exercise physiologist consultation based on stress test and clinical data passed from the physician) all subjects will begin their secondary prevention program including on-site supervised training, nurse case management, plus dietitian and psychological consultation as necessary. During the study weeks subjects will wear the smartwatch (Polar Inc.) in order to collect de-identified data (heart rate, step count, walk speed etc.) and will upload data to the Polar cloud. No medical data will be uploaded and subjects will only have a coded ID randomly generated. During the exercise periods (both on-site in the cardiac rehabilitation institute, and also during the recommended community exercise performed on their own).
Gradually, the number of on-site sessions will decrease from the standard of 8 sessions per month to zero (each month after the first a reduction of 2 sessions). We plan to reduce the on-site sessions while increasing the number of home-based session in order to evaluate the ability to monitor, coach and dynamically adjust the exercise program by combined use of smartwatch data and telephone contact. Polar exercise watch will be provided and appropriate operation instructions and education will be given after informed consent.
During the 6 month study period we will contact subjects once or twice weekly in order to encourage participation, fine-tune the exercise program and to assess secondary prevention goals.
All subjects will undergo a stress test before and after 6 months of training part of the standard of care management, as well as dietitian, physician and psychologist consultations will be offered following the regular schedule of the standard rehabilitation program (at baseline, 3 months and 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm non-blinded remote monitored multidisciplinary secondary prevention intervention
| Arm | Type | Receives |
|---|---|---|
| Tele cardiac rehabilitation | Experimental | Behavioral: Tele Cardiac RehabilitationFollowing a standard intake process, patients will begin exercise in the institute and will gradually over a period of 6 months reduce the number of institution visits and will concomitantly increase the number of home \ community exercise sessions. During the entire period we will monitor program, coach and fine-tune the exercise program. Weekly exercise data will be securely transmitted to the rehabilitation team (heart rate zones, duration of exercise and type, step count, caloric expenditure, blood pressure and patients reported impressions) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Coronary disease (S/p ACS, PCI, CABG or stable angina with documented coronary disease)
- Age ≥ 21
- Smartphone with internet connection
- Willing and able to comply with study protocol and
- LVEF > 40% and Baseline METS ≥ 5
Key exclusion criteria (15 listed)
- Heart failure (clinical) or unresolved significant arrhythmia (i.e. symptomatic atrial fibrillation)
- Significant neurological or cognitive impairment
- Women of child-bearing potential
- Symptomatic hypotension, orthostatic hypotension or repeated blood pressure systolic value <100 mmHg without symptoms
- ACS or percutaneous coronary intervention (PCI) within 30 days prior to screening, or having undergone CABG surgery within 30 days prior to screening
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 |
|---|---|---|
| Tele Cardiac RehabilitationComprehensive intervention according to the secondary prevention goals | Behavioural | Tele cardiac rehabilitation |
Primary outcome
Exercise capacity
Time frame: 6 months
Stress bases METS assessment
4 secondary outcomes
Subject satisfaction
Time frame: 3 and 6 months
Adherence to exercise program
Time frame: 3 and 6 months
Quality of life
Time frame: 3 and 6 months
Device ease of use and technical difficulties
Time frame: 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele Cardiac Rehabilitation in people with Coronary Artery Disease, run by Sheba Medical Center at 1 site in Israel.
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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meirav Moreno (97235302361, Merav.Moreno@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2018.