Table 4.
Change in secondary outcomes (sleep and mood) by exercise arm
| Intent to Treat Analysis1 | N | Exercise Mean (95% CI) |
N | Usual Activity Mean (95% CI) |
Difference Mean (95% CI) |
p-value2 | |
|---|---|---|---|---|---|---|---|
| ISI Sleep | 0.025 | ||||||
| Baseline | 104 | 11.5 (10.4, 12.7) | 140 | 12.2 (11.4, 13.1) | −0.7 (−2.1, 0.7) | ||
| Week 12 – baseline | 80 | −4.0 (−5.1, −2.9) | 130 | −3.1 (−3.9, −2.4) | −0.9 (−2.2, 0.4) | ||
|
| |||||||
| PSQI Sleep | 0.007 | ||||||
| Baseline | 103 | 7.8 (7.1, 8.5) | 139 | 8.4 (7.8, 8.9) | −0.6 (−1.4, 0.2) | ||
| Week 12 – baseline | 79 | −2.4 (−3.1, −1.7) | 131 | −1.6 (−2.1, −1.1) | −0.8 (−1.6, 0.0) | ||
|
| |||||||
| Depression (PHQ-8) | 0.028 | ||||||
| Baseline | 105 | 4.0 (3.2, 4.8) | 140 | 4.1 (3.5, 4.6) | −0.1 (−1.1, 0.9) | ||
| Week 12 – baseline | 78 | −0.9 (−1.6, −0.1) | 133 | 0.1 (−0.5, 0.7) | −1.0 (−2.0, 0.0) | ||
|
| |||||||
| Anxiety (GAD-7) | 0.156 | ||||||
| Baseline | 106 | 3.4 (2.6, 4.2) | 142 | 3.0 (2.5, 3.5) | 0.4 (−0.5, 1.3) | ||
| Week 12 – baseline | 82 | −0.8 (−1.6, −0.1) | 135 | −0.1 (−0.7, 0.4) | −0.7 (−1.6, 0.2) | ||
1
includes all participants with follow-up measures, regardless of adherence to intervention
2
p-values from contrasts comparing exercise vs. usual activity in a linear model of outcome as a function of intervention arm, clinical center, omega-3 intervention assignment, and baseline outcome value. A p-value < 0.0125 was considered statistically significant when accounting for the 4 secondary outcome comparisons of interest.
3
hot flash frequency values were log transformed for modeling