Table 2. Six-Month Changes From Baseline in Study Measures and Between-Group Differences in the Change From Baselinea.
| Measure | Mean (SD) [Sample Size] | Usual Care vs High-Intensity Exercise | Usual Care vs Moderate-Intensity Exercise | ||||
|---|---|---|---|---|---|---|---|
| High-Intensity Exercise | Moderate-Intensity Exercise | Usual Care | Δ (CI)b | t Statistic (P Value)c | Δ (CI)b | t Statistic (P Value)c | |
| Primary Outcomes | |||||||
| UPDRS motor, primary analysisd | 0.3 (6.3) [39] | 2.0 (5.3) [42] | 3.2 (5.6) [38] | 2.9 (<4.7) | −0.42 (.34) | 1.2 (<2.8) | −1.9 (.03) |
| UPDRS motor, sensitivity analysis, off stated | 0.2 (6.3) [39] | 1.7 (6.0) [42] | 3.2 (5.6) [38] | 3.0 (<4.8) | −0.36 (.36) | 1.5 (<3.2) | −1.51 (.07) |
| UPDRS motor, sensitivity analysis, multiple imputationd | 0.5 (6.2) [43] | 1.9 (5.2) [45] | 3.2 (5.5) [40] | 2.7 (<4.4) | −0.62 (.27) | 1.2 (<2.8) | −1.9 (.03) |
| Secondary Outcomes | |||||||
| UPDRS Totald | 2.1 (7.2) | 3.0 (7.2) | 3.9 (6.3) | 1.8 (−1.3 to 4.9) | 1.18 (.24) | 0.9 (−2.1 to 3.9) | 0.60 (.55) |
| Part 1d | 0.3 (1.4) | −0.04 (1.2) | 0.05 (1.0) | −0.3 (−0.8 to 0.3) | −1.04 (−.30) | 0.1 (−0.4 to 0.6) | 0.40 (.69) |
| Part 2 d | 1.4 (3.4) | 1.0 (3.5) | 0.6 (2.4) | −0.8 (−2.2 to 0.5) | −1.23 (.22) | −0.4 (−1.7 to 1.0) | −0.55 (.59) |
| MDS-UPDRS motore | 0.3 (8.2) | 1.8 (7.4) | 4.2 (7.4) | 4.0 (0.4 to 7.5) | 2.21 (.03) | 2.4 (−0.9 to 5.7) | 1.46 (.15) |
| Part 1e | 1.0 (3.1) | −0.1 (3.2) | 0.7 (2.4) | −0.3 (−1.6 to 1.0) | −0.46 (.65) | 0.8 (−0.4 to 2.1) | 1.29 (.20) |
| Part 2e | 1.5 (3.3) | 0.7 (3.0) | 0.9 (2.8) | −0.6 (−2.0 to 0.8) | −0.84 (.40) | 0.2 (−101 to 1.5) | 0.27 (.79) |
| V̇o2max, mL/kg/minf | 1.9 (2.9) [35] | 0.1 (4.4) [41] | −1.3 (2.5) [36] | −3.2 (−4.5 to −1.9) | −5.03 (<.001) | −1.4 (−3.0 to 0.2) | −1.77 (.08) |
| Total step countg | 187 (3146) [31] | −334 (1929) [38] | −291 (2736) [31] | −477 (−1975 to 1021) | −0.64) (.53) | 44 (−1080 to 1167) | 0.08 (.94) |
Abbreviations: MDS, Movement Disorders Society; UPDRS, Unified Parkinson’s Disease Rating Scale.
High-intensity treadmill exercise was 4 days per week at 80%-85% maximum heart rate; moderate-intensity treadmill exercise, 4 days per week at 60%-65% maximum heart rate.
Difference between the usual care group changes and the exercise group changes. The CIs are 1-sided 90% CIs for the primary outcomes and 2-sided 95% CIs for the secondary outcomes. For the primary outcomes, a 90% upper confidence bound for Δ that is greater than 3.5 indicates that the data are consistent with the hypothesis that exercise is associated with a 3.5 lessening of motor symptom progression on the UPDRS motor score.
The t statistic represents the comparison of each exercise group’s mean change with the mean change in the usual care group relative to the variability of these changes and sample sizes in the groups. For the primary outcomes, t values and P values are null adjusted for the 3.5 futility threshold and 1-sided test (α = .10). A t value less than −1.28 (P < .10) indicates that data are not consistent with the hypothesis that exercise is associated with a 3.5 lessening of motor symptom progression on the UPDRS motor score. For the secondary outcomes, t values and P values are 2-sided tests with null equal to 0 (α = .05).
The UPDRS part 1 (mentation, behavior, and mood) is a summation of 4 items on a 5-point Likert scale scored 0 to 4; part 2 (activities of daily living), 13 items on a 5-point Likert scale scored 0 to 4; part 3 (motor), 27 items on a 5-point Likert scale scored 0 to 4; and total, 44 items on a 5-point Likert scale scored 0 to 4.
The MDS-UPDRS part 1 (nonmotor) is a summation of 13 items on a 5-point Likert scale scored 0 to 4; part 2 (daily living), 13 items on a 5-point Likert scale scored 0 to 4; and part 3 (motor), 33 items on a 5-point Likert scale scored 0 to 4.
V̇o2max is the maximal aerobic power in milliliters of oxygen consumed per kilogram of body weight per minute.
Activity was measured by waist-worn ActiGraph GT3X+ and GT3X-BT accelerometers (Actigraph).