Clinical trial NCT02575976: Effects of Cardiac Rehabilitation (CR) on Functional Capacity and Cardiovascular Risk Factors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Coronary Disease
Keywords: Rehabilitation
Coronary artery disease
Patient Education
Randomized Controlled Trial
Protocol
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. participants come to CR for 12 sessions, 3x a week (total of 4 weeks of intervention).
2. participants come to CR for 8 sessions, 2x a week (total of 4 weeks of intervention).
3. 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:

1. undertake the shuttle walk test as the indicator of functional capacity,
2. undertake assessments of secondary outcomes including a blood draw for lipids, and
3. 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.

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.

Primary outcomes:
measure: Functional Capacity Assessed by Changes in Total Distance Walked in the Incremental Shuttle Walk Test
timeFrame: Functional capacity measured by walked distance in the ISWT at 6 months
Secondary outcomes:
measure: Risk Factors Measurement of Systolic Blood Pressure
timeFrame: Systolic blood pressure measured at 6 months
measure: Risk Factors Measurement of Waist Circumference.
timeFrame: Waist circumference measured at 6 months
measure: Risk Factors Measurement of Fasting Blood Glucose Values
timeFrame: Glycaemia measured at 6 months
measure: Risk Factors Measurement of Total Cholesterol Values.
timeFrame: Cholesterol measured at 6 months.
Other outcomes:
measure: Heart-health Behaviors
timeFrame: Measured at 6 months.
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Raquel R Britto, Post doc
role: PRINCIPAL_INVESTIGATOR
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