Hautala 2017.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Country: Finland Dates participants recruited: February 2011 to May 2014 Maximum follow‐up: 12 months |
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Participants |
Inclusion criteria: CAD patients who suffered from acute coronary syndrome, with coronary angiography to confirm the CAD. Exclusion criteria: NYHA class ≥ III, scheduled or emergency procedure for bypass surgery, unstable angina pectoris, severe peripheral atherosclerosis, diabetic retinopathy or neuropathy, or inability to perform regular home‐based exercises, for example, due to severe musculo‐skeletal problems N randomised: total: 204; intervention: 109; comparator: 95 Diagnosis (% of participants): intervention: NSTEMI 47 (48%); STEMI 44(45%); comparator: NSTEMI 45 (58%); STEMI 28 (36%) Age (mean): intervention: 60 ± 11; comparator: 62 ± 9 Percentage male: intervention: 80 (73%); comparator: 67 (71%) Ethnicity (white, %): NR |
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Interventions |
Intervention: the 1‐year exercise training intervention consisted of home‐based aerobic (30 to 40 min) and gym‐based strength exercises (30 to 40 min).
On the first two visits to the gym, participants were provided instruction on use of the gym, a home‐base exercise training program for the first month, how to fill in the exercise training diary, use of the RPE scale to evaluate the average intensity of a single exercise session, a schedule for gym visits, and use of an accelerometer. Thereafter, the participants exercised in the gym once per week for 6 months in groups of no more than eight participants. A wrist‐worn accelerometer was provided to improve motivation and adherence. Participants instructed to continuously wear the accelerometer and monitor their own daily PA. After 6 months, home‐based exercise continued and checkpoint visits to monitor progression of exercise training were scheduled at 9 and 12 months. Components: exercise plus other components such as dietary counselling or check‐up by a medical doctor when appropriate. Setting: both centre and home (1 centre‐based resistance training session per week for 6 months). Exercise programme modality: walking, running, cycling or cross‐country skiing Length of session: 30 to 40 minutes Frequency: 4 to 5 per week Intensity: RPE 12‐15 (aerobic), RPE 13 (resistance) Resistance training included? Yes ‐ strength exercise circuit targeted at major muscle groups at moderate intensity (2‐3 X 7 sets, ≥ 10 repetitions/set) RPE 13. Total duration: 1 year Co‐interventions: None described Comparator: usual care – participants did not receive any individually‐tailored exercise prescriptions. Co‐interventions: none described |
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Outcomes | Mortality, hospitalisations, HRQoL, cost effectiveness | |
Source of funding | NR | |
Conflicts of interest | JMA is a partner of ESiOR Oy, which provides health economic and outcome research services to pharmaceutical and medical device companies. The other authors report no conflicts of interest. | |
Notes | Authors provided further data relating to clinical outcomes and HRQoL. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided regarding method used to generate allocation sequence |
Allocation concealment (selection bias) | Unclear risk | No information provided regarding method used to conceal the allocation sequence |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided regarding blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Missing data balanced in numbers (intervention 28%, control 26%); missing data were imputed using appropriate methods, but reasons for loss to follow‐up not reported. |
Selective reporting (reporting bias) | Unclear risk | No published protocol available, clinical trial registry available, but outcome information is limited |