Table 2.
Clinical and demographic characteristics of the ALS patients at diagnosis (T0), admission to the study protocol (T1), and the end of study (T2). T-Test: mean and standard deviation values for both groups.
| Group 1 (n = 24) | Group 2 (n = 24) | p value | |
|---|---|---|---|
| Male (%) | 18 (75%) | 14 (59%) | 0.20 |
| Spinal onset form (%) | 21 (88%) | 17 (70%) | 0.12 |
| Use of NIV T1-T2 (Yes – No) | 14Y/10N | 13Y/11N | 0.75 |
| Age at onset (years) | 63.21 (±13.0) | 62 (±12.06) | 0.42 |
| Disease duration (T0-T1) (months) | 10.8 (±6.5) | 10.79 (±7.7) | 0.80 |
| % FVC predicted (T1) | 99.64 (±21.8) | 80.0 (±21.0) | 0.002 |
| ALSFRS-R total score (T0) | 42.92 (±3.51) | 41.13 (±4.83) | 0.14 |
| ALSFRS-R total score (T1) | 40.25 (±5.00) | 37.25 (±4.9) | 0.042∗ |
| ALSFRS-R total score (T2) | 34.1 (±7.1) | 29.5 (±7.7) | 0.035 |
| ALSFRS-R Tot sc. slope (T1-T2) | 1.01 (±0.92) | 1.28 (±1.10) | 0.36 |
| ALSFRS-R bulbar slope (T1-T2) | 0.15 (±0.24) | 0.18 (±0.25) | 0.62 |
| ALSFRS-R spinal slope (T1-T2) | 0.66 (±0.64) | 0.75 (±0.97) | 0.68 |
| ALSFRS-R respiratory slope (T1-T2) | 0.20 (±0.26) | 0.30 (±0.32) | 0.23 |
G1: controlled exercise Group, G2: standard care group, T0: at diagnosis; T1: at start of to study; T2: end of study; Sp: spinal onset, Bb: bulbar onset; use of NIVT1-T2: use of noninvasive ventilation during period of study; % FVC predicted T1: % forced vital capacity predicted at start of study (T1); ALSFRS-TTotal Diagnosis: ALSFRS-R total at diagnosis moment; ALSFRS-Rtotal T2: ALSFRS-R total at end of study; slope ALSFRS-RTotal T1-T2: slope ALSFRS-R total between start and end of exercise protocol (T1-T2); significant results (p ≤ 0.05) are represented in bold. ∗ALSFRS-R total score on T1 (Subscores between G1 and G2 (NS): bulbar score: p = 0.14; spinal score: p = 0.12; Respiratory score: p = 0.93).