Table 3.
Between-group comparisons of the changes in the primary, key secondary and exploratory outcomes from baseline to 12-month follow-up for the per-protocol population*
| n | Intervention | n | Standard care | Difference or OR | P value | |
| Primary outcome | ||||||
| SF-36 PCS (points) | 34 | 0.9 (−0.9 to 2.8) | 26 | −2.2 (−4.4 to −0.1) | 3.1 (0.3 to 6.0) | 0.031 |
| Key secondary outcomes | ||||||
| SF-36 PCS responders, n (%)† | 34 | 9 (26) | 26 | 6 (23) | 3.32 (0.50 to 21.90)‡ | 0.212 |
| SF-36 MCS (points) | 34 | 2.2 (−0.2 to 4.6) | 26 | 0.4 (−2.3 to 3.2) | 1.8 (−1.9 to 5.4) | (0.334) |
| SF-36 MCS responders, n (%)† | 34 | 9 (26) | 26 | 9 (35) | 1.04 (0.10 to 10.96)‡ | (0.976) |
| Other exploratory outcomes | ||||||
| MHC-SF (points) | 34 | 1.4 (−1.1 to 3.8) | 26 | 1.6 (−1.1 to 4.4) | −0.3 (−4.0 to 3.4) | (0.883) |
| Languishing, n (%) | 32 | 0 (0) | 25 | 0 (0) | NA | |
| Moderately mentally healthy, n (%) | 5 (16) | 6 (24) | 0.26 (0.04 to 1.88)§ | (0.183) | ||
| Flourishing, n (%) | 27 (84) | 19 (76) | 3.28 (0.41 to 25.95)§ | (0.261) | ||
| WEMWBS (points) | 32 | 2.8 (1.6 to 4.0) | 25 | 2.3 (1.0 to 3.7) | 0.5 (−1.3 to 2.3) | (0.569) |
| SF-36 Physical functioning (points) | 34 | 1.6 (0.5 to 2.6) | 26 | −0.9 (−2.1 to 0.4) | 2.4 (0.8 to 4.1) | (0.004) |
| SF-36 Physical role functioning (points) | 34 | 1.0 (−1.2 to 3.1) | 26 | −2.5 (−4.9 to 0.0) | 3.4 (0.1 to 6.7) | (0.043) |
| SF-36 Bodily pain (points) | 34 | −2.3 (−5.1 to 0.4) | 26 | −3.6 (−6.7 to −0.4) | 1.2 (−2.9 to 5.3) | (0.563) |
| SF-36 General health (points) | 34 | 5.0 (3.2 to 6.8) | 26 | 0.3 (−1.8 to 2.3) | 4.8 (2.0 to 7.5) | (0.001) |
| SF-36 Vitality (points) | 34 | 3.3 (0.8 to 5.8) | 26 | −0.6 (−3.5 to 2.3) | 3.9 (0.0 to 7.8) | (0.048) |
| SF-36 Social functioning (points) | 34 | 0.4 (−1.7 to 2.5) | 26 | −0.2 (−2.6 to 2.3) | 0.6 (−2.7 to 3.8) | (0.728) |
| SF-36 Emotional role functioning (points) | 34 | 1.3 (−0.8 to 3.4) | 26 | 0.7 (−1.7 to 3.1) | 0.6 (−2.6 to 3.8) | (0.722) |
| SF-36 Mental health (points) | 34 | 2.5 (−0.3 to 5.3) | 26 | −1.5 (−4.7 to 1.7) | 4.1 (−0.2 to 8.3) | (0.062) |
| GMS Positive affect (points) | 33 | 2.8 (1.0 to 4.6) | 25 | 0.8 (−1.3 to 2.9) | 2.0 (−0.8 to 4.8) | (0.150) |
| GMS Negative affect (points) | 33 | −1.1 (−2.6 to 0.4) | 25 | −0.6 (−2.3 to 1.2) | −0.5 (−2.8 to 1.8) | (0.658) |
For continuous outcomes, estimates are adjusted least squares means (95% CI) from linear mixed models. For dichotomous outcomes, estimates are adjusted ORs (95% CI) from logistic regression with repeated measures. Group-wise estimates for dichotomous outcomes are n (%) at 12-month follow-up. P values in parentheses should be interpreted with caution, since they represent analyses performed after the gatekeeping procedure indicated discontinuation of analyses.
*The per-protocol population was defined specifically by adherence to medication and attendance to medical consultations, and for the U-TURN group, specifically, attendance to 70% or more of the prescribed exercise sessions.
†Responders defined as participants achieving a clinically significant improvement from baseline to 12-month follow-up: PCS improvement ≥3.4 points, MCS improvement ≥4.6 points.
‡Numbers represent the adjusted OR (95% CI).
§Numbers represent the adjusted OR (95% CI) comparing current category to the two other categories combined.
GMS, global mood scale; MCS, mental component score; MHC-SF, mental health continuum-short form; NA, not applicable; PCS, physical component score; SF-36, 36-item short form health survey; WEMWBS, Warwick-Edinburgh mental well-being scale.