VHSG 2003.
Study characteristics | ||
Methods |
Study design: Multicentre RCT (3 sites) Country: Norway Dates participants recruited: NR Maximum follow‐up: 2 years |
|
Participants |
Inclusion criteria: participants 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 participants): 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). Participants were then encouraged to perform regular training at home. Components: exercise, education and psychological support. Setting: supervised, group sessions in a centre. Exercise programme modality: "dynamic endurance training". Length of session: 55 min. Frequency: twice a week. Intensity: RPE 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: participants 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. |