Effects of Cardiac Rehabilitation (CR) on Functional Capacity and Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial are to pragmatically investigate whether participation in a comprehensive CR (i.e., exercise with education) program in a Latin American MIC results in better functional capacity, cardiovascular risk factor control, health behavior, disease-related knowledge, depressive symptoms and lower mortality when compared exercise only CR or wait list control.

Detailed Description
-----------------
The design is a single-blinded, single-site pragmatic superiority RCT with 3 parallel arms: comprehensive CR (education and exercise) versus exercise-based CR (no education, as delivered in Brazil) versus wait list control (i.e., no CR). Patient assessments will be undertaken pre-randomization and again at 6 and 12 months later (in accordance with the end of CR). Mortality will be ascertained at 6 months and 1 year post-recruitment. The main program is 6 months in duration, with 36 1-hour exercise sessions offered at the following frequencies: participants come to CR for 12 sessions, 3x a week (total of 4 weeks of intervention). participants come to CR for 8 sessions, 2x a week (total of 4 weeks of intervention). participants come to CR for 12 sessions, 1x a week (total of 12 weeks of intervention). Each participant will receive an individualized exercise prescription based on a grade exercise stress test. Participants will be exercising between 50 and 80% of heart rate reserve. In all stages patients will be requested to exercise in their community other days of the week, to accumulate 30 or more minutes of physical activity at a moderate to vigorous-intensity 5 or more days per week, as recommended in the guidelines. In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration. More specifically, the education component consists of: weekly group education sessions, which are strategically mapped based on patients' information needs and sequenced to support the program learning outcomes. Education sessions are delivered by a health educator team. See table 1 for the CR program schedule, including educational topics (e.g.. diet, medication and exercise). A comprehensive education workbook to accompany the sessions, containing 20 chapters. The empirically-validated English version has been translated and culturally-adapted to Brazilian-Portuguese. Clinicians and patients have reviewed the material, and a plain language and clear design review was completed in preparation for this trial. The standard of care for Brazilian adults with CVD does not include access to CR for all patients, given the gross lack of capacity. All participants will have follow-up appointments with their physician as deemed medically appropriate. Consistent with CONSORT guidelines, usual care will be described in detail for each participant (e.g., number of health visits - both inpatient and outpatient, other treatments). The number of patients approached and date will be recorded, as well as the reasons for inclusion/exclusion. With informed written consent from the patient and CR clearance from the physician, potentially eligible participants will be scheduled to come on-site to complete pre-test assessments. Participants will be asked to complete a sociodemographic questionnaire, to establish the generalizability of the sample, among other surveys. Clinical information will be extracted from participants' charts. Eligible participants will be randomized to one of the 3 groups. The randomization sequence was generated using the random.org website in random blocks of 4, with a 1:1:1 allocation ratio. To ensure allocation concealment, the local principal investigator has the allocation sequence in a password-protected file, and will only provide randomization information to the student once it is confirmed the participant is eligible. Due to the nature of the intervention, participants and the doctoral student cannot be blind to treatment allocation. The primary outcome of functional capacity will be assessed again at 6 months. All other post-test assessments will be undertaken 6 months post-randomization. Mortality will be ascertained from hospital charts and family phone call at 6 months and 1-year. With regard to the baseline and 6 months assessments, participants will be invited to come to the study center to: undertake the shuttle walk test as the indicator of functional capacity, undertake assessments of secondary outcomes including a blood draw for lipids, and complete surveys related to tertiary outcomes. A master's student blinded to random allocation will undertake post-test assessments, outcome ascertainment and data entry. To minimize loss to follow-up, investigators will send mail and telephone reminders for patients to come on-site for these assessments, based on the Dillman method. Measures Participants will be asked to complete a sociodemographic questionnaire. Clinical characteristics will be extracted from the medical charts, including sex, age, risk factors, cardiac history, cardiac test results, comorbidities and medications. These are based on the Canadian Cardiovascular Society core element and demographic data definitions. CR session attendance will be extracted from program charts at post-test for participants randomized to the CR arms.

Official Title
-----------------
Effects of Cardiac Rehabilitation on Functional Capacity and Cardiovascular Risk Factors in Brazilian Patients Assisted by Public Health Care: A Randomized Controlled Trial

Conditions
-----------------
Cardiovascular Disease, Coronary Disease

Intervention / Treatment
-----------------
* Behavioral: comprehensive CR
* Other: exercise-based CR
* Other: wait list control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients older than 18 years old patients living in the Belo Horizonte area Exclusion Criteria: any comorbid physical or serious mental condition which would interfere with the ability to exercise according to CR clinical practice guidelines (i.e., heart failure with ejection fraction less than 45%, complex ventricular dysrhythmia, advanced dementia, leg amputation, advanced cancer, disabling stroke, Parkinson's or substance dependence), and any visual or cognitive condition which would preclude the participant from completing the questionnaires.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: comprehensive CR<br>education and exercise-based cardiac rehabilitation | Behavioral: comprehensive CR<br>* In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)<br>|
| Active Comparator: exercise-based CR<br>Exercise-based cardiac rehabilitation | Other: exercise-based CR<br>* The main program is 6 months in duration, with 36 1-hour exercise sessions.<br>|
| Other: wait list control<br>no cardiac rehabilitation | Other: wait list control<br>* No cardiac rehabilitation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capacity Assessed by Changes in Total Distance Walked in the Incremental Shuttle Walk Test | The Incremental Shuttle Walk Test (ISWT). The ISWT consists of an incremental, walking test where participants are required to walk up and down a 10-meter course. The speed of walking, which is increased by a small increment every minute (0.17 ms-l), is externally paced and controlled by audio signals played from a tape recorder19. There are 12 levels in total, beginning with 0.5 ms-1, and each level lasts for one minute. At the end of each minute, exercise heart rate (HR) and rating of perceived exertion (RPE) scores will be recorded. For this test, the higher the number of meters, the higher the functional capacity. | Functional capacity measured by walked distance in the ISWT at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Factors Measurement of Systolic Blood Pressure | Blood pressure was assessed using the validated 7670-06 mobile stand (Welch Allyn Inc., Skaneateles Falls, NY, USA). Mean systolic blood pressure value was recorded, and hypertension was considered where values exceed 140/90 mmHg and/or participant was taking a blood pressure-lowering medication | Systolic blood pressure measured at 6 months | 
| Risk Factors Measurement of Waist Circumference. | Waist circumference was assessed at the superior border of the iliac crest. Values greater than 102 cm in men and 88 cm in women were considered indicative of central obesity. | Waist circumference measured at 6 months | 
| Risk Factors Measurement of Fasting Blood Glucose Values | Fasting blood glucose values were extracted from center charts. Dysglycemia was considered present where fasting blood glucose exceeded 126 mg/dl and/or participant was taking a glucose-lowering medication | Glycaemia measured at 6 months | 
| Risk Factors Measurement of Total Cholesterol Values. | Total cholesterol values were extracted from center charts and dyslipidemia was considered present where total cholesterol values exceeded 240 mg/dl and/or participant was on a lipid-lowering agent. | Cholesterol measured at 6 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Coronary artery disease, Patient Education, Randomized Controlled Trial, Protocol