Design of the training levels comparison trial.
The Training Levels Comparison (TLC) trial was a grant-supported, multicenter, randomized, controlled clinical trial designed to determine whether cardiac rehabilitation patients would benefit from supervised exercise for a prolonged period (2 years) and whether subjecting patients to a more vigorous exercise program than currently recommended would provide additional cardiac benefit. If high-intensity exercise does not enhance the cardiac benefit, then physical activity should be limited to low-intensity levels that are safer, easier to implement and more adaptable to a greater number of patients. Patients were randomly assigned to either a low-intensity or high-intensity training program. All patients were to attend three 1-hour supervised exercise sessions per week for a period of 2 years. Attendance at exercise sessions and adherence to assigned treatments were monitored throughout the study. Patients were evaluated for outcome measures at 3, 6, 12, and 24 months. This paper reports the study design and methodology for the TLC trial, and should be useful in providing methodologies to facilitate comparison of data from other studies with different levels of exercise as an intervention.
Lee
J Y
JY
Biostatistics Unit, University of Alabama at Birmingham 35294-3300.
Oberman
A
A
Fletcher
G F
GF
Raczynski
J M
JM
Fletcher
B J
BJ
Nanda
N C
NC
Jensen
B E
BE
D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000502:physiology; D015992:Body Mass Index; D001835:Body Weight / Q000502:physiology; D003327:Coronary Disease / Q000503:physiopathology / Q000534:rehabilitation*; D015444:Exercise / Q000502:physiology*; D005500:Follow-Up Studies; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D008055:Lipids / Q000097:blood; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D010809:Physical Fitness / Q000502:physiology*; D016277:Ventricular Function, Left / Q000502:physiology
D008055:Lipids