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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Tele Cardiac Rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Robert Klempfner, Prof.
    • Contact: Email: robert.klempfner@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tele cardiac rehabilitation; 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)

Behavioral: Tele Cardiac Rehabilitation; Comprehensive intervention according to the secondary prevention goals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Stress bases METS assessment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction	Questioner based assessment of program	3 and 6 months
Adherence to exercise program	Amount of time exercising at the specified target heart rate zone per week	3 and 6 months
Quality of life	QOL questioners	3 and 6 months
Device ease of use and technical difficulties	Questioners and transmission failures or usability issues	1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): July 20, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 24, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: SMC-17-4154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No