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

NCT03228225 | Unknown

• 1 other identifier: SMC-17-4154
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Stress bases METS assessment

  6 months

Secondary Outcomes (4)

• Subject satisfaction

  3 and 6 months

• Adherence to exercise program

  3 and 6 months

• Quality of life

  3 and 6 months

• Device ease of use and technical difficulties

  1, 3 and 6 months

Study Arms (1)

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)

Behavioral: Tele Cardiac Rehabilitation

Interventions

Tele Cardiac Rehabilitation BEHAVIORAL

Comprehensive intervention according to the secondary prevention goals

Tele cardiac rehabilitation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Meirav Moreno

CONTACT

97235302361; Merav.Moreno@sheba.health.gov.il

Robert Klempfner, Prof.

CONTACT

97235303068; robert.klempfner@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac rehabilitation institute

Model Details: single arm non-blinded remote monitored multidisciplinary secondary prevention intervention

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 24, 2017
• Study Start: November 1, 2017
• Primary Completion: July 20, 2018
• Study Completion: August 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

IL (1)