Chaves 2019.
Study characteristics | ||
Methods |
Study design: superiority RCT with waiting‐list control (single centre) Country: Brazil Dates participants recruited: March 2015 to April 2017 Maximum follow‐up: 12 months ‐ 6 months waiting‐list control |
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Participants |
Inclusion criteria: participants aged > 18 years and living in the Belo Horizonte area, with coronary artery disease: post myocardial infarction undergone percutaneous coronary intervention or coronary artery bypass graft surgery and had been referred to CR Exclusion criteria: cardiac conditions associated with some risk during high‐intensity exercise (e.g. heart failure with EF < 45%, complex ventricular dysrhythmia), any comorbid physical condition (e.g. leg amputation, advanced cancer, disabling stroke, Parkinson’s disease), or serious mental illness that would interfere with the ability to exercise, according to CR clinical practice guidelines, or any visual or cognitive condition that would preclude the participant from completing the questionnaires N randomised: total: 115; intervention 1 (exercise only): 39; intervention 2 (comprehensive CR): 37; comparator: 39 Diagnosis (% of participants): participants with CAD after MI or those undergoing PCI/CABG. MI 107 (93%), angina 69 (60%), PCI 68 (59.1%), CABG 29 (25.5%). Age (mean): intervention 1: 59 ± 9.9; intervention 2: 60.7 ± 8.8; comparator: no CR (n = 16) 55.9± 6.7, exercise only (n = 12) 60.7 ± 13.3, comprehensive CR (n = 11) 60.6 ± 8.4 Percentage male: intervention 1: 28 (71.8%); intervention 2: 27 (73%); comparator: no CR (n = 16) 11 (68.8%), exercise only (n = 12) 12 (100%), comprehensive CR (n = 11) 4 (36.4%) Ethnicity (white, %): NR |
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Interventions |
Intervention: CR program led by a physician and staffed by physiotherapists. Exercise programme 6 months, consisting of 36 1‐hour supervised sessions descending in frequency. Participants provided individualised exercise prescription based on exercise test. Participants requested to exercise in their communities on non‐centre‐based exercise days to accumulated ≥ 30 minutes of MVPA on ≥ 5 days per week. Comprehensive CR participants were offered an additional 24, weekly 30‐minute education sessions, delivered in groups by a health educator, and received a validated education workbook to accompany the sessions. Components: exercise only (group 1); exercise plus education (group 2) Setting: centre‐based (with request to complete home‐based exercise in addition) Exercise programme modality: treadmill/bike/walking Length of session: 1 hour Frequency: 3 times per week for 4 weeks, 2 times per week for 4 weeks, once per week for 16 weeks. Intensity: 50% to 80% heart rate reserve Resistance training included? NR Total duration: 6 months Co‐interventions: education sessions provided for comprehensive CR group (group 2). Educational curriculum included: information about the CR program, their aerobic exercise prescription and safety, managing angina, irregular heartbeats, diabetes, exercising in cold and hot weather, the heart (anatomy, pathophysiology, diagnoses, and treatment) and cardiac medications risk factor profile, goal setting and action planning, resistance training, nutrition (fats, fibre, reading food labels, sodium), psychosocial risk, and sexual intimacy, how much physical activity is good, aerobic and resistance training progression, relapse planning, and graduation. Comparator: waiting‐list control – all participants received follow‐up appointments with their physician as deemed medically important. Participants in the control arm received CR after 6‐month mortality ascertained. Participants elected whether they wanted to have exercise only or comprehensive CR, or no CR. Co‐interventions: none |
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Outcomes | Cardiovascular mortality, MI, revascularisations, hospitalisations | |
Source of funding | Professor Britto was supported by Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq no. 305786/2014‐8), Fundacao de Amparo a Pesquisa do Estado de Minas Gerais (FAPEMIG no. PPM‐00869‐15 and CS00290‐16) and Coordination for the Improvement of Higher Education Personnel (CAPES) | |
Conflicts of interest | None declared | |
Notes | Outcomes at 6 months only used for this review, as waiting‐list control participants elected which arm of the study to go into after this point. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “The randomisation sequence was generated by a professor not involved in the study using the randomization.com website in random blocks of four, with a 1:1:1 allocation ratio.” |
Allocation concealment (selection bias) | Low risk | “To ensure allocation concealment, the principal investigator (RB) had the allocation sequence in a password‐protected file, and only provided randomisation information to the PhD student once it was confirmed the participant was eligible.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “A master’s student blinded to random allocation was responsible for post‐test assessments, outcome ascertainment and data entry.” |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: control 9/39 (23%), comprehensive CR 5/37 (14%), exercise‐only CR 8/39 (20%) |
Selective reporting (reporting bias) | Low risk | Outcomes reported in protocol are reported in main paper in addition to event and rate. |