−1 | 0 | T1 | T2 | T3 | T4 | T5 | ||||
---|---|---|---|---|---|---|---|---|---|---|
Activity/ Assessment | CRF (Y/N) | Staff member | Approximate time to complete | Pre-study screening/ consent | Pre-study baseline/ randomization | Study visit 1 immediately post-randomization | Study/ interim visit 2 (3 months) | Study/ interim visit 3 (6 months) | Post-intervention follow-up (3 months) | Post-intervention follow-up (6 months) |
Pre-screening consent | N | Study Coordinator | 5 min | X | ||||||
Screening log | N | Study Coordinator | 5 min | X | ||||||
Inclusion/ exclusion form | Y | Study Coordinator | N/A | X | ||||||
Demographic data | Y | Interviewer | 10 min | X | ||||||
Anthropometric data | Y | Assessor | 5 min | X | ||||||
Gait speed, general, temporal and spatial variables | N | Assessor | 15 min | X | X | X | X | X | ||
Displacement of the body center of mass during quasi-static posture | N | Assessor | 15 min | X | X | X | X | X | ||
Functional balance tests | Y | Assessor | 15 min | X | X | X | X | X | ||
Mobility test | Y | Assessor | 10 min | |||||||
Reaction time | Y | Assessor | 10 min | X | X | X | X | X | ||
Confidence and fear of falls | Y | Interviewer | 10 min | X | X | X | X | X | ||
Quality of life | Y | Interviewer | 10 min | X | X | X | X | X | ||
Depression symptoms | Y | Interviewer | 10 min | X | X | X | X | X | ||
Fall episodes | Y | Interviewer | Monthly | |||||||
Adverse events | Y | Study Coordinator | N/A | As needed throughout the protocol | ||||||
Adherence to the exercise program | Y | Interviewer | Monthly |