Table 2.
Six-minute walk test and clinical evaluation
| 490 m
|
1,650 m
|
2,590 m
|
P-value | ||||
|---|---|---|---|---|---|---|---|
| First day | Second day | First day | Second day | First day | Second day | ||
| 6-minute walk distance, m | 534±93 | 547±93* | 512±93*,# | 525±93#,† | 491±93*,#,†,‡ | 504±93#,‡,¶ | <0.001 |
| SpO2, rest, % | 94 (94; 96) | 94 (93; 95) | 92*,# (91; 94) | 93*,# (91; 95) | 89*,#,†,‡ (88; 91) | 90*,#,†,‡ (87; 92) | <0.001 |
| SpO2, end of 6MWT, % | 90 (84; 92) | 89 (83; 92) | 84*,# (78; 87) | 85*,# (77; 87) | 78*,#,†,‡ (73; 82) | 77*,#,†,‡ (73; 82) | <0.001 |
| Borg dyspnea | 3.0 (2.0; 5.0) | 3.0 (3.0; 4.5) | 4.0 (2.0; 4.5) | 4.0*,#,† (3.0; 5.5) | 3.5 (3.0; 5.0) | 4.0*,#,† (3.0; 6.0) | 0.003 |
| Borg leg fatigue | 2.5 (2.0; 4.0) | 3.0 (1.0; 5.0) | 2.5 (1.5; 4.0) | 3.0 (1.0; 4.0) | 2.0 (0.8; 3.0) | 3.0 (1.5; 3.0) | 0.567 |
| mMRC dyspnea score | 1 (0; 1) | 1 (1; 1) | 1 (1; 1) | 1 (1; 1) | 1 (1; 1) | 1# (1; 1) | 0.045 |
| Acute mountain sickness score | 0.00 (0.00; 0.09) | 0.00 (0.00; 0.00) | 0.00 (0.00; 0.18) | 0.00 (0.00; 0.09) | 0.18*,#,†,‡ (0.00; 0.35) | 0.00¶ (0.00; 0.09) | <0.001 |
| Weight, kg | 77.3 (67.9; 87.4) | 77.3 (68.2; 87.4) | 78.2*,# (66.6; 88.6) | 78.3*,# (67.4; 87.9) | 78.3*,# (67.9; 88.0) | 78.6*,# (67.5; 87.9) | <0.001 |
Notes: Six-minute walk distance analyzed by the intention-to-treat analysis including all 40 randomized patients, values presented as mean ± SD. Other outcomes analyzed by the per-protocol approach including 32 patients, values presented as median (quartiles). P-values from Friedman ANOVA.
*
P<0.05 vs 490 m day 1,
#
P<0.05 vs 490 m day 2,
†
P<0.05 vs 1,650 m day 1,
‡
P<0.05 vs 1,650 m day 2,
¶
P<0.05 vs 2,590 m day 1.
Abbreviations: 6MWT, 6-minute walk test; mMRC, modified Medical Research Council dyspnea score; SpO2, pulse oximetry.