Initial design | Modified design | Rationale |
---|---|---|
Three-arm trial (n = 300) | two-arm trial (n = 200) | Enrollment |
• 36 weeks SMT + SRE (n = 88) | • 36 weeks SMT + SRE (n = 100) | Funding |
• 12 weeks SMT + SRE (n = 124) | • 12 weeks SMT + SRE (n = 100) |  |
• 36 weeks SRE alone (n = 88) |  |  |
n = 300 | n = 200 (for primary and secondary aims 1–4) | Enrollment |
n = 18 (for additional secondary aims A-C) | Funding | |
Randomization ratio 1:1.4:1 | Final randomization ratio 1:1 | Enrollment |
Funding | ||
Pertinent inclusion/exclusion criteria: | Pertinent inclusion/exclusion criteria: | Enrollment |
• NDI and ODI ≥ 15% each at both baseline evaluations | • NDI and ODI ≥ 10% each AND combined score of ≥ 25% at first baseline evaluation only | |
Functional outcomes: | Functional outcomes: | Funding |
• short physical performance battery | ||
• hand grip strength | ||
• accelerometry | • short physical performance battery | |
• postural sway | • hand grip strength | |
• range of motion | • accelerometry | |
• static endurance |