Table 2.
List of outcomes that could be applicable in phase II studies (the final choice is the responsibility of the applicant)
| Proposed endpoint | Tool to measure the endpoint |
|---|---|
| Improvement of physical performance | SPPB |
| Gait speed | |
| 400-m walk test | |
| TUG test | |
| Chair stand test | |
| Improvement of muscle strength | Handgrip strength |
| Knee extensor strength | |
| Increase of muscle mass | CT-scan |
| MRI | |
| DXA | |
| Urinary D-3 creatine | |
| Muscle biopsy | |
| Improvement of muscle quality* | CT-scan |
| MRI | |
| MRS | |
| Muscle biopsy | |
| Muscle metabolism | Biomarkers of muscle metabolism |
| Muscle-bone interaction | Biomarkers of muscle-bone interaction (e.g., Myostatin, Activin A, amino terminal of type III procollagen peptide (P3NP), insulin-like growth factor-1 (IGF-1) [31, 32]) |
*For example, decrease in intramyocellular lipid accumulation and intermuscular adipose tissue, increase in muscle blood flow, change in fibre types and increase in skeletal muscle mitochondrial capacity
MRS magnetic resonance spectroscopy, SPPB short physical performance battery, TUG timed Up and Go, CT-scan computerized tomography scan, MRI magnetic resonance imaging