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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.
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:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comprehensive CR | Experimental | education and exercise-based cardiac rehabilitation |
|
| exercise-based CR | Active Comparator | Exercise-based cardiac rehabilitation |
|
| wait list control | Other | no cardiac rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comprehensive CR | Behavioral | 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) |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart-health Behaviors | Assessed by questionnaires. | Measured at 6 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raquel R Britto, Post doc | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Minas Gerais | Belo Horizonte | Minas Gerais | 31270-901 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21734590 | Background | Aldcroft SA, Taylor NF, Blackstock FC, O'Halloran PD. Psychoeducational rehabilitation for health behavior change in coronary artery disease: a systematic review of controlled trials. J Cardiopulm Rehabil Prev. 2011 Sep-Oct;31(5):273-81. doi: 10.1097/HCR.0b013e318220a7c9. | |
| 10519467 | Background | Dusseldorp E, van Elderen T, Maes S, Meulman J, Kraaij V. A meta-analysis of psychoeduational programs for coronary heart disease patients. Health Psychol. 1999 Sep;18(5):506-19. doi: 10.1037//0278-6133.18.5.506. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Comprehensive CR | education and exercise-based cardiac rehabilitation comprehensive CR: 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) |
| FG001 | Exercise-based CR | Exercise-based cardiac rehabilitation exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions. |
| FG002 | Wait List Control | no cardiac rehabilitation wait list control: No cardiac rehabilitation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Comprehensive CR | education and exercise-based cardiac rehabilitation comprehensive CR: 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers. | Posted | Mean | Standard Deviation | meters | Functional capacity measured by walked distance in the ISWT at 6 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comprehensive CR | education and exercise-based cardiac rehabilitation comprehensive CR: 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Raquel Britto | Federal University of Minas Gerais | +55 31 99970-4527 | r3britto@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2015 | Mar 30, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
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| exercise-based CR | Other | The main program is 6 months in duration, with 36 1-hour exercise sessions. |
|
| wait list control | Other | No cardiac rehabilitation. |
|
| 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. |
| 1299819 | Background | Mullen PD, Mains DA, Velez R. A meta-analysis of controlled trials of cardiac patient education. Patient Educ Couns. 1992 Apr;19(2):143-62. doi: 10.1016/0738-3991(92)90194-n. |
| 21884449 | Background | Schadewaldt V, Schultz T. Nurse-led clinics as an effective service for cardiac patients: results from a systematic review. Int J Evid Based Healthc. 2011 Sep;9(3):199-214. doi: 10.1111/j.1744-1609.2011.00217.x. |
| 24529720 | Background | Ghisi GL, Abdallah F, Grace SL, Thomas S, Oh P. A systematic review of patient education in cardiac patients: do they increase knowledge and promote health behavior change? Patient Educ Couns. 2014 May;95(2):160-74. doi: 10.1016/j.pec.2014.01.012. Epub 2014 Jan 30. |
| 27849287 | Background | Chaves GS, Ghisi GL, Grace SL, Oh P, Ribeiro AL, Britto RR. Effects of comprehensive cardiac rehabilitation on functional capacity and cardiovascular risk factors in Brazilians assisted by public health care: protocol for a randomized controlled trial. Braz J Phys Ther. 2016 Nov-Dec;20(6):592-600. doi: 10.1590/bjpt-rbf.2014.0192. Epub 2016 Oct 27. |
| 25387466 | Background | Herdy AH, Lopez-Jimenez F, Terzic CP, Milani M, Stein R, Carvalho T, Serra S, Araujo CG, Zeballos PC, Anchique CV, Burdiat G, Gonzalez K, Gonzalez G, Fernandez R, Santibanez C, Rodriguez-Escudero JP, Ilarraza-Lomeli H. South American guidelines for cardiovascular disease prevention and rehabilitation. Arq Bras Cardiol. 2014 Aug;103(2 Suppl 1):1-31. doi: 10.5935/abc.2014s003. No abstract available. English, Portuguese. |
| 27542575 | Background | Grace SL, Turk-Adawi KI, Contractor A, Atrey A, Campbell NR, Derman W, Ghisi GL, Sarkar BK, Yeo TJ, Lopez-Jimenez F, Buckley J, Hu D, Sarrafzadegan N. Cardiac Rehabilitation Delivery Model for Low-Resource Settings: An International Council of Cardiovascular Prevention and Rehabilitation Consensus Statement. Prog Cardiovasc Dis. 2016 Nov-Dec;59(3):303-322. doi: 10.1016/j.pcad.2016.08.004. Epub 2016 Aug 17. |
| 30282639 | Result | Chaves GSDS, Ghisi GLM, Grace SL, Oh P, Ribeiro AL, Britto RR. Effects of comprehensive cardiac rehabilitation on functional capacity in a middle-income country: a randomised controlled trial. Heart. 2019 Mar;105(5):406-413. doi: 10.1136/heartjnl-2018-313632. Epub 2018 Oct 3. |
| 30764702 | Result | Chaves GSS, Lima de Melo Ghisi G, Britto RR, Grace SL. Maintenance of Gains, Morbidity, and Mortality at 1 Year Following Cardiac Rehabilitation in a Middle-Income Country: A Wait-List Control Crossover Trial. J Am Heart Assoc. 2019 Feb 19;8(4):e011228. doi: 10.1161/JAHA.118.011228. |
| 32694454 | Derived | Ghisi GLM, Chaves GSS, Ribeiro AL, Oh P, Britto RR, Grace SL. Comprehensive Cardiac Rehabilitation Effectiveness in a Middle-Income Setting: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2020 Nov;40(6):399-406. doi: 10.1097/HCR.0000000000000512. |
| Exercise-based CR |
Exercise-based cardiac rehabilitation exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions. |
| BG002 | Wait List Control | no cardiac rehabilitation wait list control: No cardiac rehabilitation. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Low Education | It was considered low education those participants who did not complete high school. | Count of Participants | Participants |
|
| Marital status - Married | Count of Participants | Participants |
|
| Work status - employed | Count of Participants | Participants |
|
| Low Monthly income | It was considered low monthly income those participants who receive less than four minimum wages per month. | Count of Participants | Participants |
|
| OG000 | Comprehensive CR | education and exercise-based cardiac rehabilitation comprehensive CR: 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) |
| OG001 | Exercise-based CR | Exercise-based cardiac rehabilitation exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions. |
| OG002 | Wait List Control | no cardiac rehabilitation wait list control: No cardiac rehabilitation. |
|
|
| Secondary | 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 | The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers. | Posted | Mean | Standard Deviation | mmHg | Systolic blood pressure measured at 6 months |
|
|
|
| Secondary | 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. | The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers. | Posted | Mean | Standard Deviation | centimeters | Waist circumference measured at 6 months |
|
|
|
| Secondary | 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 | The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers. Sample size reduced because difficult to obtain the results in a reasonable time frame. | Posted | Mean | Standard Deviation | mg/dl | Glycaemia measured at 6 months |
|
|
|
| Secondary | 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. | The analyzed population was based on the threshold sessions: a minimum of 24 exercise sessions and 16 education classes. The presented results considered the Per Protocol analysis, explaining the different numbers in the flow diagram and the analyzed numbers. Sample size reduced because difficult to obtain the results in a reasonable time frame. | Posted | Mean | Standard Deviation | mg/dl | Cholesterol measured at 6 months. |
|
|
|
| Other Pre-specified | Heart-health Behaviors | Assessed by questionnaires. | Not Posted | Measured at 6 months. | Participants |
| 1 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Exercise-based CR | Exercise-based cardiac rehabilitation exercise-based CR: The main program is 6 months in duration, with 36 1-hour exercise sessions. | 0 | 39 | 0 | 39 | 0 | 39 |
| EG002 | Wait List Control | no cardiac rehabilitation wait list control: No cardiac rehabilitation. | 1 | 39 | 0 | 39 | 0 | 39 |
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| D001157 |
| Arterial Occlusive Diseases |
| Male |
|