Table 2 Summary of primary and secondary outcome measures and timing of collection; baseline (T0), 9 months (T1), 21 months (T2)
Variable | Data collection method | Data collection time points |
|---|---|---|
Primary outcome measure | ||
Left total hip aBMD | DXA | T0, T1, T2 |
Secondary outcome measures | ||
Anthropometry | Height, weight, BMI, waist circumference | T0, T1, T2 |
Posture | Thoracic kyphosis angle, Tragus-to-wall | T0, T1, T2 |
Bone parameters | DXA left FN, LS and WB aBMD | T0, T1, T2 |
3D DXA proximal femur trabecular and cortical bone mass and geometry | T0, T1, T2 | |
pQCT tibia and radius trabecular, total and cortical bone mass and biomechanical strength indices | T0, T1, T2 | |
QUS calcaneal BUA, SOS and SI | T0, T1, T2 | |
Body composition | DXA WB lean mass, appendicular lean mass, fat mass and body fat % | T0, T1, T2 |
pQCT leg and forearm muscle cross-sectional area and density | T0, T1, T2 | |
Physical performance, strength, and balance | Timed up-and go; Five-times sit-to-stand; Leg extensor strength; Back extensor strength; Countermovement vertical jump; Tandem walk; Functional reach test | T0, T1, T2 |
Serum vitamin D and bone turnover markers | Blood collection | T0, T1, T2 |
Fall and fracture incidence, Safety (adverse events and injuries) | LIV/HiRIT/Control training diary entries | T0 → T1 |
HiRIT trainer records | T0 → T1 | |
Monthly email correspondence | T0 → T2 | |
Detraining diary entries | T1 → T2 | |
Physical activity enjoyment | Physical Activity Enjoyment Scale (PACES) | T0, T1, T2 |
Pelvic floor health and disability | Pelvic Floor Distress Inventory (PFDI-20); Pelvic Floor Impact Questionnaire (PFIQ-7) | T0, T1, T2 |
Health-related quality of life | Assessment of Quality of Life (AQoL-6D) | T0, T1, T2 |
Compliance monitoring | LIV/HiRIT/Control training diary entries | T0 → T1 |
LIV internal compliance data download | T1 | |
Economic evaluation | Healthcare utilization records | T0, T1, T2 |