Table 2.
Schedule of enrollment, interventions, and assessments
| TIMEPOINT | Enrollment -t1 |
Allocation 0 |
Baseline t1 |
Intervention | Follow-up 12th week post baseline t2 |
Close-out 25th week post baseline t3 |
|---|---|---|---|---|---|---|
| ENROLLMENT | ||||||
| Eligibility screen | ✓ | |||||
| Informed consent | ✓ | |||||
| Randomized Allocation | ✓ | |||||
| INTERVENTION | ✓ | |||||
| Ex-HMB | ✓ | |||||
| NoEx-HMB | ✓ | |||||
| Ex-Plac | ✓ | |||||
| Control | ✓ | |||||
| ASSESSMENTS | ||||||
| Functional capacity (primary outcome) | ||||||
| SPPB: Gait speed, balance, and 5-sit-to-stand | ✓ | ✓ | ✓ | ✓ | ||
| Muscle strength and power | ||||||
| Grip strength | ✓ | ✓ | ✓ | |||
| 1RM seated leg press | ✓ | ✓ | ✓ | |||
| 1RM vertical bench press | ✓ | ✓ | ✓ | |||
| Sit-to-stand muscle power | ✓ | ✓ | ✓ | |||
| Frailty and fall risk | ||||||
| Frailty phenotype | ✓ | ✓ | ✓ | |||
| Falls history | ✓ | ✓ | ✓ | ✓ | ||
| Fall risk assessment | ✓ | ✓ | ✓ | ✓ | ||
| Body composition | ✓ | ✓ | ||||
| Blood pressure and resting heart rate | ✓ | ✓ | ✓ | |||
| Haematology | ✓ | ✓ | ✓ | |||
| Biochemical analyses | ✓ | ✓ | ✓ | |||
| Nutritional status | ✓ | ✓ | ✓ | |||
| Sarcopenia | ✓ | ✓ | ✓ | |||
| Disability and comorbidity | ||||||
| Barthel index | ✓ | ✓ | ✓ | |||
| Lawton index | ✓ | ✓ | ✓ | |||
| Comorbidity | ✓ | ✓ | ✓ | |||
| Cognitive function | ✓ | ✓ | ✓ | ✓ | ||
| Depression | ✓ | ✓ | ✓ | |||
Ex: 12-week of VIVIFRAIL multicomponent exercise program. HMB: dietary supplementation of HMB. Plac Placebo. SPPB Short Physical Performance Battery; 1RM one-repetition maximum