Table 4.
Response of secondary outcome measures to the PEDAL intervention
| Outcome measure | na | Baseline | Month 6 | Adjusted mean difference in change between EX and CON groupsb | P valuec |
|---|---|---|---|---|---|
| Peak aerobic capacity (VO2 peak, l/min) | |||||
| CON | 68 | 0.97 (0.38) | 0.96 (0.37) | 0.05 (−0.03 to 0.12) | 0.22 |
| EX | 75 | 0.95 (0.42) | 0.98 (0.43) | ||
| Peak aerobic capacity (VO2 peak, ml/min/kg) | |||||
| CON | 68 | 11.9 (4.5) | 11.8 (4.2) | 0.75 (−0.20 to 1.71) | 0.12 |
| EX | 74 | 11.8 (5.3) | 12.4 (5.7) | ||
| Arterial stiffness by pulse wave velocity (ms)22 | |||||
| CON | 78 | 8.10 (6.78, 9.29) | 7.78 (6.97, 9.13) | 1.01 (0.97–1.06) | 0.54 |
| EX | 78 | 7.92 (6.62, 9.09) | 7.88 (6.98, 9.27) | ||
| DASI (AU) | |||||
| CON | 121 | 23.1 (13.1) | 22.7 (13.4) | 0.35 (−2.23 to 2.93) | 0.79 |
| EX | 112 | 24.9 (13.3) | 24.1 (14.3) | ||
| IPAQ total physical activity (MET, min/wk) [ln(x + 10)] | |||||
| CON | 118 | 423.8 (39.0, 1465.4) | 353.2 (46.1, 1033.1) | 1.36 (0.84–2.21) | 0.21 |
| EX | 106 | 709.5 (153.8, 2515.1) | 591.0 (111.8, 1793.2) | ||
| Gait speed in 10 m (m/s) | |||||
| CON | 84 | 0.86 (0.30) | 0.87 (0.29) | 0.01 (−0.04 to 0.06) | 0.73 |
| EX | 79 | 0.94 (0.29) | 0.94 (0.30) | ||
| Sit-to-stand 60 s (no. of repetitions) | |||||
| CON | 87 | 13.8 (6.6) | 14.4 (7.0) | 1.02 (−0.42 to 2.47) | 0.16 |
| EX | 82 | 15.8 (7.1) | 17.1 (8.1) | ||
| Tinetti Falls Efficacy Scale (AU) [ln(x)] | |||||
| CON | 122 | 22.5 (10.2, 46.8) | 24.5 (11.0, 50.0) | 0.94 (0.80–1.12) | 0.49 |
| EX | 112 | 23.0 (11.8, 49.2) | 24.5 (11.0, 46.2) |
AU, arbitrary units; CON, control group; DASI, Duke Activity Status Index; EX, exercise intervention group; IPAQ, International Physical Activity Questionnaire; MET, metabolic equivalent task; PEDAL, PrEscription of intraDialytic exercise to improve quAlity of Life; VO2, maximum rate of oxygen consumption.
Data are mean (SD), median (IQR), or mean (95% confidence interval); some variables were transformed to enhance model fit: transformations are given in [brackets]. CON—usual care maintenance hemodialysis; EX—intradialytic exercise training plus usual care maintenance hemodialysis.
Number of participants with baseline and 6-month data available.
Adjusting for baseline data and the randomization minimization variables (age, gender, diabetes status): note variables analyzed as log-transformed values are given as ratios.
Comparison between the control and intervention groups using a normal linear model.