Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1
Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1
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.
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).
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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

 -  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