Tele-Cardiac Rehabilitation Program
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|ClinicalTrials.gov Identifier: NCT03584828|
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases||Behavioral: Tele Cardiac Rehabilitation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comprehensive Remote Multidisciplinary Cardiac Rehabilitation Program for Patients Unable to Attend an Institution Based Program|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: Tele-Rehabilitation - intervention
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
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.
No Intervention: Usual care
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.
- Change in METS [ Time Frame: 6 month ]Exercise capacity change by stress test
- First CV hospitalization or death [ Time Frame: 1-12 month ]Time to first cardiovascular hospitalization or death
- Health status [ Time Frame: 1-12 month ]General clinical status (worsened\ unchanged\ improved)
- QOL [ Time Frame: 1-12 month ]Assessed by validated questioner
- Time alive and out of hospital [ Time Frame: 1-12 month ]
- Depression [ Time Frame: 1-12 month ]Assessed by PHQ-9
- Time to return to work [ Time Frame: 1-12 month ](if applicable)
- Medication compliance [ Time Frame: 1-12 month ]Use of guideline recommended medication and dose attained (% of target)
- Fasting Glucose [ Time Frame: 1-12 month ]levels of fasting blood glucose
- Activity [ Time Frame: 1-6 month ]average weekly steps
- TCR group adherence [ Time Frame: 1-6 month ]Percent of total exercise time at the designated target heart rate zone
- TCR group sessions > 10 min adherence [ Time Frame: 1-6 month ]Number of exercise sessions > 10 minutes per month (within target heart rate designated zone)
- Lipid profile [ Time Frame: 1-6 months ]Lipid profile dynamics
- Diabetes management [ Time Frame: 1-6 months ]HB A1C %
- BMI [ Time Frame: 1-6 months ]Change in BMI from baseline to 3 and 6 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584828
|Sheba Medical Center, Cardiac Rehabilitation Institute|
|Tel Hashomer, Israel, 52621|