Table 3.
Data collection scheme for primary and secondary outcome measures
| Baseline | 12 Weeks | 60 Weeks | |
|---|---|---|---|
| PRIMARY OUTCOME VARIABLES | |||
| Body size and composition (adiposity) | X | X | X |
| Weight, body mass index, waist circumference, percent body fat and lean mass | |||
| Cardiac Structure | X | X | X |
| Echocardiogram (left ventricular end diastolic diameter) | |||
| Functional Status | X | X | X |
| Cardiopulmonary exercise test & 6-minute walk test | |||
| SECONDARY OUTCOME VARIABLES | |||
| Lipid Profiles | X | X | X |
| Total cholesterol, triglycerides, LDL-C, HDL-C | |||
| Glycemic Control and insulin resistance | X | X | X |
| HbAlc, Fasting blood sugar, Homeostasis Model Assessment | |||
| QOL Measurement | X | X | X |
| Minnesota Living with Heart Failure Questionnaire | |||
| ADDITIONAL VARIABLES | |||
| Sociodemographic Characteristics | X | ||
| Sociodemographic Form | |||
| Clinical History | X | ||
| Clinical History/Co-Morbidity Form | |||
| Biochemical analyses | X | X | X |
| BNP, serum creatinine, serum albumin, CRP | |||