Tele-Cardiac Rehabilitation Program

NCT03584828 | Unknown

• 1 other identifier: 4916-18 -SMC
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Rehabilitation programs that take place in hospitals and rehabilitation centers and all over the world are a necessary stage for returning the patients after a cardiac event to a normal functioning. However, about 70% of patients do not apply for the hospital rehabilitation programs after the heart event that they experience. The objective of this study is to evaluate and develop a multi-stage home rehabilitation program for remote rehabilitation, based on advanced technological infrastructure and complementary clinical protocols. The study population will include about 264 clinically stable patients who are eligible for cardiac rehabilitation, but for various reasons cannot get to the rehabilitation centers.

Conditions

Heart Diseases

Keywords

Cardiac Rehabilitation; exercise

Outcome Measures

Primary Outcomes (1)

• Change in METS

  Exercise capacity change by stress test

  6 month

Secondary Outcomes (14)

• First CV hospitalization or death

  1-12 month

• Health status

  1-12 month

• QOL

  1-12 month

• Time alive and out of hospital

  1-12 month

• Depression

  1-12 month

Study Arms (2)

Tele-Rehabilitation - intervention

EXPERIMENTAL

Following the standard rehabilitation intake process the subjects in the Tele-rehaab arm will receive physiologic consultation based on clinical stress tests and clinical data passed from the physician. The Tele-rehab arm will receive an exercise prescription and execution will be assessed and periodically adjusted in accordance to data received from the wearable device. Intensity and type of exercise will be moderate and will comply with exercise recommendations provided by ESC guidelines. A dedicated application will be installed on the mobile phone for patients in the research group and they will receive a smart sports watch.

Behavioral: Tele Cardiac Rehabilitation

Usual care

NO INTERVENTION

The usual care arm will receive general recommendations for a healthy and active lifestyle and community cardiologist and primary care physician according to local guidelines.

Interventions

Tele Cardiac Rehabilitation BEHAVIORAL

A multidisciplinary intervention that aims to optimize structured exercise performed in the community as prescribed by rehabilitation cardiologist, cardiac care nurse, and exercise physiologist. Additionally, in the intervention arm, we will provide psychological support, dietary intervention and disease management services that complement the structured physical activity - all by innovative smartphone applications and smart wearable devices, thus complementing the comprehensive secondary prevention program.

Tele-Rehabilitation - intervention

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A guideline-based and Israeli Health Basket approved indications for cardiac rehabilitation yet participant declines to participate in center based cardiac rehabilitation due to non-medical reasons such as: distance, service availability in subjects living are, time constraints and other logistic or sociocultural barriers
• Age ≥ 21
• Compatible smartphone (android or iOS) with internet connection
• Willing and able to comply with study protocol
• Able and willing to follow the personalized exercise prescription, use wearable technology and smartphone app, and upload data via personal smartphone

You may not qualify if:

• Any unresolved cardiac condition associated with significantly increased risk during outpatient activity (clinically significant ischemia, unresolved arrhythmia, high falling risk etc.)
• End stage \\ NYHA 4 or unstable heart failure (clinical) or unresolved significant arrhythmia (i.e. Rapid atrial fibrillation)
• LVEF ≤35% without ICD \\ CRTD
• Significant neurological or cognitive impairment or markedly unstable gait \\ high falling risk
• Women of child-bearing potential
• ACS within 30 days prior to screening, or having undergone cardiac surgery within 30 days prior to screening
• Inability to perform a stress test due to physical limitations
• 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
• Severe Aortic or Mitral stenosis
• 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, Cardiac Rehabilitation Institute

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Heart Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Cardiovascular Prevention and Rehabilitation Institute, Sheba Medical Center, Israel

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 12, 2018
• Study Start: July 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: July 1, 2020
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

IL (1)