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. 2021 Nov 6;2021(11):CD001800. doi: 10.1002/14651858.CD001800.pub4

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
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
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
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