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Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tele Cardiac Rehabilitation
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tele cardiac rehabilitation

Arm Description

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)

Outcomes

Primary Outcome Measures

Exercise capacity
Stress bases METS assessment

Secondary Outcome Measures

Subject satisfaction
Questioner based assessment of program
Adherence to exercise program
Amount of time exercising at the specified target heart rate zone per week
Quality of life
QOL questioners
Device ease of use and technical difficulties
Questioners and transmission failures or usability issues

Full Information

First Posted
July 17, 2017
Last Updated
June 24, 2018
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03228225
Brief Title
Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1
Official Title
Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
July 20, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single arm non-blinded remote monitored multidisciplinary secondary prevention intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele cardiac rehabilitation
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Tele Cardiac Rehabilitation
Intervention Description
Comprehensive intervention according to the secondary prevention goals
Primary Outcome Measure Information:
Title
Exercise capacity
Description
Stress bases METS assessment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Subject satisfaction
Description
Questioner based assessment of program
Time Frame
3 and 6 months
Title
Adherence to exercise program
Description
Amount of time exercising at the specified target heart rate zone per week
Time Frame
3 and 6 months
Title
Quality of life
Description
QOL questioners
Time Frame
3 and 6 months
Title
Device ease of use and technical difficulties
Description
Questioners and transmission failures or usability issues
Time Frame
1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meirav Moreno
Phone
97235302361
Email
Merav.Moreno@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Klempfner, Prof.
Phone
97235303068
Email
robert.klempfner@sheba.health.gov.il
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Klempfner, Prof.
Email
robert.klempfner@sheba.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Tele - Cardiac Rehabilitation - Providing Secondary Prevention and Supervised Exercise Without Boundaries of Time and Space - PILOT 1

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