Clinical trial NCT03584828: Tele-Cardiac Rehabilitation Program
Official title: Comprehensive Remote Multidisciplinary Cardiac Rehabilitation Program for Patients Unable to Attend an Institution Based Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Keywords: Cardiac Rehabilitation
exercise
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-07-12
Enrollment: 264
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise, dietary intervention, secondary prevention by pharmacotherapy, and psychological intervention. Despite proven benefits including reduction in mortality, hospitalizations and marked improvement in well-being and function state, the current model is restrictive and requires patients' arrival to the hospital twice a week at predetermined hours. Major limitations associated with lack of participation in an in-hospital based cardiac rehabilitation program in 20-40% of eligible patients include limited transportation, time and social/family restraints, and inconvenience. Furthermore, the limited space, even in the largest rehabilitation in Israel located at Sheba Medical Center, prohibits wider availability. Leading key opinions leaders have designated cardiac-telerehabilitation as the most viable solution for the above-mentioned limitations, and several clinical studies have demonstrated safety and efficacy of this approach, including a Cochrane review and a recent meta-analysis. Nevertheless, tele-cardiac rehabilitation is not guideline recommended yet, and prospective randomized trials are necessary to better evaluate its role.

Study will enroll patients who are eligible to participate in an in-hospital cardiac rehabilitation program but are unable to participate due to one of the above-mentioned limitations, in a structured exercise and secondary prevention program in their communities. Consenting patients will undergo a baseline cardiopulmonary exercise test (CPET) followed by randomization to usual care vs. multidisciplinary intervention as described.

In addition to monitored physical activity, patients will receive nutritional and psychological counseling. This is part of a multi-professional rehabilitation program accepted by the rehabilitation center.

The study will enroll and randomize 264subjects to usual care vs. comprehensive tele-cardiac rehabilitation (TCR) with disease management services and demonstrate a greater improvement in functional capacity (O2 consumption) and improved clinical outcomes (secondary endpoints) in the TCR group.

Concomitant medications and guidelines: As indicated by national guidelines. No limitations

Study Duration: 12-month intervention period. Primary endpoint (percent change in O2 consumption) will be assessed following 3 months of intervention. Clinical event adjudication (hospitalizations, emergency department visits) will be performed throughout a 12-month period from enrollment.

Study Design: The study is an open-labeled double arm randomized prospective multi-center study designed to assess the effects of tele-CR compared to usual care in subjects that are unable to attend institution based CR despite compelling indications to CR. The intervention will be evaluated against usual care by family physician and cardiologist. The multidisciplinary program will include elements of education, nutritional and psychological interventions, monitored personalized exercise and medication titration according to the relevant national guidelines. The present sample will facilitate an evaluation of the hypothesis that tele-rehabilitation will be associated with a significant improvement in functional capacity, as assessed by the gold standard of CPET. We also hypothesize that the comprehensive intervention will also reduce clinical events, including all-cause hospitalization and death.

All subjects will undergo a detailed evaluation by rehabilitation specialist, nurse case manager, trainers and exercise physiologists. Both research arms will receive a dedicated application with a built-in pedometer and the ability to answer questionnaires.

Eligibility criteria: Inclusion Criteria:

Eligible patients must meet all of the following inclusion criteria during the initial screening visit of the study (visit 1):

* 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

Exclusion Criteria:

Eligible patients must meet none of the following exclusion criteria:

* 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

Primary outcomes:
measure: Change in METS
timeFrame: 6 month
Secondary outcomes:
measure: First CV hospitalization or death
timeFrame: 1-12 month
measure: Health status
timeFrame: 1-12 month
measure: QOL
timeFrame: 1-12 month
measure: Time alive and out of hospital
timeFrame: 1-12 month
measure: Depression
timeFrame: 1-12 month
measure: Time to return to work
timeFrame: 1-12 month
measure: Medication compliance
timeFrame: 1-12 month
measure: Fasting Glucose
timeFrame: 1-12 month
measure: Activity
timeFrame: 1-6 month
measure: TCR group adherence
timeFrame: 1-6 month
measure: TCR group sessions > 10 min adherence
timeFrame: 1-6 month
measure: Lipid profile
timeFrame: 1-6 months
measure: Diabetes management
timeFrame: 1-6 months
measure: BMI
timeFrame: 1-6 months
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center, Cardiac Rehabilitation Institute
Study officials:
References: