Figure 1.

The flow of participants through the TOM Trial is depicted. A two-stage screening process was used. Of 4,726 participants who underwent telephone screening, 1,240 were deemed eligible for further screening, 571 signed consent and were screened in person, 278 met eligibility criteria, and 209 were randomized. Participants with limited exercise tolerance or those at high risk of cardiovascular events underwent a modified testing protocol, which included unloaded 40-m walk test, Bassey’s leg power, physical activity, and self-reported measures (Group A). All others underwent a cardiopulmonary exercise tolerance test. Participants who demonstrated evidence of ischemia or exercise intolerance during exercise tolerance test were assigned to Group B and underwent loaded and unloaded walk and stair-climb, leg-press strength and power, and self-reported measures. Participants who underwent an exercise tolerance test without demonstrating ischemic changes underwent complete battery of tests, including loaded and unloaded walk and stair-climb, lift and reach, leg press and chest press, physical activity, and self-reported measures (Group C).