Table 4.
Safety outcomes by aerobic physical fitness training or relaxation session (control group)
| Events | Aerobic physical fitness training (n=105) | Relaxation sessions (n=95) | Total cohort (n=200) | Incidence rate ratio (95% CI)* |
|---|---|---|---|---|
| Serious adverse events† (from baseline to three months after stroke) | ||||
| Median (interquartile range) follow-up (days) | 68 (56-78) | 69 (54-77) | 66 (56-78) | |
| Total No | 22 | 9 | 31 | |
| Incidence rate/100 person months (95% CI) | 13.19 (9.22 to 18.86) | 7.28 (4.39 to 12.08) | 10.38 (7.75 to 13.90) | 1.81 (0.97 to 3.36) |
| Cardiovascular event | 0 | 0 | 0 | - |
| No with recurrent stroke | 8 | 3 | 11 | - |
| Incidence rate/100 person months (95% CI) | 3.52 (1.76 to 7.03) | 1.46 (0.47 to 4.52) | 2.54 (1.41 to 4.58) | 2.41 (0.64 to 9.10) |
| No of hospital admissions | 14 | 5 | 19 | - |
| Incidence rate/100 person months (95% CI) | 6.15 (3.64 to 10.39) | 2.43 (1.01 to 5.83) | 4.39 (2.80 to 6.87) | 2.53 (0.91 to 7.04) |
| No of deaths | 0 | 1 | 1 | - |
| Incidence rate/100 person months (95% CI) | - | 0.49 (0.07 to 3.45) | 0.23 (0.03 to 1.64) | 0.30 (0.01 to 7.42)‡ |
| Self reported adverse events§ (during intervention period) | ||||
| Median (interquartile range) follow-up time (days) | 33 (29-36) | 22 (28-36) | 33 (29-36) | |
| No of falls | 36 | 14 | 50 | - |
| Incidence rate/100 person months (95% CI) | 32.40 (23.37 to 44.92) | 13.84 (8.19 to 23.36) | 11.8 (8.9 to 15.5) | 2.34 (1.26 to 4.34) |
| No of fractures | 0 | 0 | 0 | - |
| No with pain | 68 | 44 | 112 | - |
| Incidence rate/100 person months (95% CI) | 61.20 (48.25 to 77.62) | 43.49 (32.36 to 58.44) | 26.1 (21.7 to 31.4) | 1.41 (0.96 to 2.06) |
| No with fatigue | 29 | 21 | 50 | - |
| Incidence rate/100 person months (95% CI) | 26.10 (18.14 to 37.56) | 20.76 (13.53 to 31.83) | 23.55 (17.85 to 31.07) | 1.26 (0.72 to 2.20) |
| No with dizziness | 5 | 14 | 19 | - |
| Incidence rate/100 person months (95% CI) | 4.50 (1.87 to 10.81) | 13.84 (8.19 to 23.36) | 8.95 (5.71 to 14.03) | 0.33 (0.12 to 0.90) |
| Other | 8 | 4 | 12 | - |
| Incidence rate/100 person months (95% CI) | 7.20 (3.60 to 14.40) | 3.95 (1.48 to 10.53) | 5.65 (3.21 to 9.95) | 1.82 (0.55 to 6.05) |
*
Calculated using Poisson regression.
†
Serious adverse event can belong to more than one category (eg, recurrent stroke and hospital admission). Thus total number of participants with a serious adverse event does not equal sum of individual categories of serious adverse events.
‡
Calculated using penalised maximum likelihood logistic regression (firthlogit command in stata).
§
Adverse events can occur multiple times in a participant. Time interval ranges from baseline to follow-up at three months after stroke or until last observation, if participant dropped out.