Haskell 1994.

Methods	Study design: Multicentre RCT (4 sites) Country: USA Dates patients recruited: February 1984 to March 1987 Maximum follow up: 4 years
Participants	Inclusion criteria: Men and women < 75 years of age with clinically indicated coronary arteriography who lived within a 5‐hour drive of Stanford University and considered capable of following the study protocol. After arteriography, patients received PCI or CABG and remained eligible if at least one major coronary artery had a segment with lumen narrowing between 5% and 69% that was unaffected by revascularisation procedures. Exclusion criteria:Severe congestive heart failure, pulmonary disease, intermittent claudication, or noncardiac life‐threatening illnesses; no qualifying segments, medical complication occurred during angiography, left ventricular ejection fraction of less than 20%, or patient was in another research study. N Randomised: total: 300; intervention: 145; comparator: 155 Diagnosis (% of pts): CHD: 100% Age (mean ± SD): intervention: 58.3 ± 9.2; comparator: 56.2 ± 8.2 Percentage male: 86% Ethnicity: NR
Interventions	Intervention: A physical activity programme consisting of an increase in daily activities such as walking, climbing stairs, and household chores and a specific endurance exercise training programme* with the exercise intensity based on the subject's treadmill exercise test performance. Components: exercise plus education. Setting: home. Aerobic exercise: Modality: stationary cycling or walking. Length of session: 30 min. Frequency: 5 days a week. Intensity: 70% to 85% of the peak heart rate attained on exercise testing at 3 weeks, an average of 96 to 121 beats/min. Resistance training included? no. Total duration: NR Co‐interventions: Each risk‐reduction subject met with a nurse to design an individualised risk‐reduction programme based on the subject's risk profile, his or her motivation, and resources for making specific changes. Patients were instructed by a dietitian in a low‐fat, low‐cholesterol, and high‐carbohydrate diet with a goal of < 20% of energy intake from fat, < 6% from saturated fat, and < 75mg of cholesterol per day. Current or recent ex‐smokers were provided with an individualised stop‐smoking or relapse‐prevention programme by a staff psychologist. Comparator: usual care. Co‐interventions: none described.
Outcomes	Total & CHD mortality, non fatal MI, revascularisation at yr 1, 2, 3 and 4.
Source of funding	National Heart, Lung, and Blood Institute and a gift from the Claude R. Lambe Charitable Foundation. Lipid drugs for patients in the risk reduction group provided by The Upjohn Company, Merck & Company, and Parke‐Davis, Inc.
Conflicts of interest	NR
Notes	*This exercise programme followed guidelines developed previously for home‐based exercise training of cardiac patients (Miller 1984). The rate of change in the minimal coronary artery diameter was 47% less in I than C. This was still significant when adjusted for age and baseline segment diameter (P = 0.03).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization was performed using a random‐numbers table."
Allocation concealment (selection bias)	Low risk	"....sequentially numbered, sealed opaque envelopes for each stratification category that were provided by the biostatistician".
Blinding of outcome assessment (detection bias) All outcomes	High risk	"The staff collecting data in the clinic were not blinded to group assignment of subjects".
Incomplete outcome data (attrition bias) All outcomes	High risk	18% lost to follow up, no description of withdrawals or dropouts.
Selective reporting (reporting bias)	Low risk	All outcomes reported at all time points.
Groups balanced at baseline	High risk	“Significant differences between the usual‐care and risk‐reduction groups include body weight and HDL‐C”
Intention‐to‐treat analysis conducted	High risk	No.
Groups received same treatment (apart from the intervention)	High risk	“After baseline evaluations, subjects were randomized to the usual care of their own physician or to an individualized, multifactor, risk‐reduction program managed by the SCRIP staff in cooperation with the patient's personal physician “ “Patients assigned to risk reduction were provided individualized programs involving a low‐fat and ‐cholesterol diet, exercise, weight loss, smoking cessation, and medications to favourably alter lipoprotein profiles.”