VHSG 2003.

Methods	Study design: Multicentre RCT (3 sites) Country: Norway Dates patients recruited: NR Maximum follow up: 2 years
Participants	Inclusion criteria: Patients admitted to hospital for acute MI, unstable angina pectoris or after coronary artery bypass grafting. Exclusion criteria: none described. N Randomised: total: 197; intervention: 98; comparator: 99 Diagnosis (% of pts): AMI: 37% UAP stabilised: 2% PCI: 20% CABG: 25% Age (mean ± SD): intervention: 54 ± 8; comparator: 55 ± 8 Percentage male: intervention: 91%; comparator: 84% Ethnicity: NR
Interventions	Intervention: The first phase lasted for 6 weeks with supervised physical exercise in addition to a regular group meeting twice a week. Each training session started with 15 min of warm up followed by 20 min of dynamic endurance training, 10 min of active cool‐down activities and finally 10 min of stretching and relaxation. Large muscle groups in the arms and legs were used simultaneously to achieve higher exercise intensity (11‐13 on the Borg scale). No weight lifting took place. This was followed by 9 weeks of supervised physical exercise twice weekly. The intensity level was increased to achieve an exertion rate equal to jogging (13‐15 on the Borg scale). Patients were then encouraged to perform regular training at home. Components: exercise, education and psychogocial support. Setting: supervised, group sessions in a centre. Aerobic exercise: Modality: "dynamic endurance training". Length of session: 55 min. Frequency: twice a week. Intensity: 11‐13 on the Borg Scale, increased to 13‐15 after 6 weeks. Resistance training included? No. Total duration: 15 weeks. Co‐interventions: The multidisciplinary CR of "Heart School" comprised dietary advice, smoking cessation, physical activity counselling, risk factor management, psychosocial management and health education. Comparator: Usual care: patients received usual standardised nurse‐based information on CHD in general and lifestyle measures. Co‐interventions: none described.
Outcomes	Total mortality.
Source of funding	The Norwegian Government Directory for Health and Bristol Myers Squib, Norway.
Conflicts of interest	NR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"randomised"
Allocation concealment (selection bias)	Low risk	"[Randomization] was performed with pre‐prepared sealed opaque envelopes containing details on group allocation. The patients opened the envelopes themselves so that their allocation to IP or UC was revealed to them without the prior knowledge of the study investigators".
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding not described.
Incomplete outcome data (attrition bias) All outcomes	High risk	17.8 % lost to follow up, no description of withdrawals or dropouts.
Selective reporting (reporting bias)	Low risk	All outcomes were reported at all time points.
Groups balanced at baseline	Low risk	“none of the intergroup differences were significant”
Intention‐to‐treat analysis conducted	High risk	No.
Groups received same treatment (apart from the intervention)	High risk	Patients in the IP group were subjected to a six‐week period of “heart school"….. this multidisciplinary cardiac rehabilitation comprised lifestyle intervention, such as dietary advice, smoking cessation, physical activity counselling, risk factor management, psychosocial management and health education….”