Table 2.
6-Month Change in Study Outcomes in the GOALS Trial
| Outcome Measures | No. | Mean (SD) | Change (95% CI) | P Value | ||
|---|---|---|---|---|---|---|
| Baseline | 6-Month Change | Within-Group Change | With-Control Comparison | |||
| Primary outcome | ||||||
| 6-min walk distance, meter | ||||||
| Control | 90 | 353.3 (91.9) | 342.2 (110.8) | −11.4 (−25.4 to 3.2) | 0 [Reference] | <.001 |
| Intervention | 88 | 357.4 (97.6) | 399.8 (101.6) | 42.4 (27.9 to 56.8) | 53.5 (33.2 to 73.8) | |
| Secondary outcomes | ||||||
| Total treadmill walk time, min | ||||||
| Control | 87 | 7.56 (4.69) | 8.09 (5.14) | 0.53 (−0.14 to 1.19) | 0 [Reference] | .04 |
| Intervention | 86 | 7.91 (4.72) | 9.44 (5.95) | 1.54 (0.87 to 2.20) | 1.01 (0.07 to 1.95) | |
| Pain-free treadmill walking time, min | ||||||
| Control | 68 | 3.12 (2.79) | 3.54 (2.76) | 0.42 (−0.18 to 1.02) | 0 [Reference] | .02 |
| Intervention | 77 | 2.72 (1.89) | 4.15 (3.06) | 1.43 (0.87 to 2.00) | 1.02 (0.19 to 1.84) | |
| Change in physical activity measured over 7 d, activity units | ||||||
| Control | 88 | 671.6 (337.6) | 645.0 (333.5) | −26.6 (−98.4 to 45.2) | 0 [Reference] | .03 |
| Intervention | 87 | 778.0 (410.7) | 866.1 (405.4) | 88.1 (15.9 to 160.3) | 114.7 (12.8 to 216.5) | |
| WIQdistance scorea | ||||||
| Control | 88 | 33.3 (25.5) | 34.4 (27.2) | 1.1 (−3.9 to 6.2) | 0 [Reference] | .003 |
| Intervention | 88 | 35.3 (27.6) | 47.4 (29.7) | 12.1 (7.1 to 17.1) | 11.1 (3.9 to 18.1) | |
| WIQspeed scorea | ||||||
| Control | 90 | 35.3 (22.8) | 36.6 (24.6) | 1.1 (−3.4 to 5.6) | 0 [Reference] | .004 |
| Intervention | 88 | 36.1 (23.8) | 47.7 (26.0) | 11.7 (6.7 to 16.6) | 10.4 (3.4 to 17.4) | |
| WIQstair-climbing scorea | ||||||
| Control | 90 | 47.9 (25.6) | 48.5 (27.8) | 0.60 (−4.9 to 6.1) | 0 [Reference] | .05 |
| Intervention | 88 | 48.9 (26.0) | 57.3 (24.5) | 8.5 (2.9 to 14.0) | 7.9 (0 to 15.8) | |
| PCSb | ||||||
| Control | 90 | 40.1 (5.1) | 39.7 (5.5) | −0.3 (−1.7 to 1.0) | 0 [Reference] | .38 |
| Intervention | 88 | 40.5 (6.3) | 41.0 (5.9) | 0.63 (−0.5 to 1.7) | 0.83 (−1.0 to 2.7) | |
| MCSb | ||||||
| Control | 90 | 38.2 (5.7) | 38.8 (6.0) | 0.6 (−0.8 to 2.0) | 0 [Reference] | .72 |
| Intervention | 88 | 39.4 (5.9) | 39.6 (5.7) | 0.2 (−1.2 to 1.6) | −0.36 (−2.3 to 1.6) | |
Abbreviations: GOALS, Group Oriented Arterial Leg Study; MCS, Mental Composite Score; PCS, Physical Composite Score; SF-12, Medical Outcomes Study Short-Form Health Survey; WIQ, Walking Impairment Questionnaire.
a
The WIQ is scored on a 0- to 100-point scale in which 0 indicates extreme difficulty and 100 indicates no difficulty with the walking distance, walking speed, and stair-climbing elements.
b
PCS and MCS are both from the SF-12, which is used to assess global dimensions of health-related quality of life. The SF-12 is scored on a 0- to 100-point scale in which 0 indicates the most severe limitation and 100 indicates no limitation.