Table 3.
Primary and secondary outcomes at test occasions (ITT and PP)
| Baseline (ITT/PP) | Pretest (ITT/PP) | Midtest (ITT/PP) | Posttest (ITT/PP) | p‐value (ITT) | p‐value (PP) | |
|---|---|---|---|---|---|---|
| Primary outcome | ||||||
| 6MWT (incl. outlier)a | 349 ± 90/349 ± 90 | 366 ± 74/366 ± 74 | 420 ± 93/420 ± 93 | 441 ± 123/466 ± 137 | .116 | .119 |
| 6MWT (excl. outlier)b | 376(284;447)/376(241;447) | 361(290;446)/361(289;446) | 393(321;490)/393(302;490) | 398(320;508)/438(298;509) | .160 | .058 |
| Secondary outcomes | ||||||
| SF‐36; physical functioningb | 45(30;60)/45(10;60) | 38(33;60)/38(25;60) | 50(20;85)/50(10;85) | 55(20;90)/70(45;93) | .375 | .157 |
| SF‐36; role limitations due to physical healthb | 50(0;100)/50(0;100) | 25(0;50)/25(0;50) | 75(25;100)/75(0;100) | 75(0;100)/100(0;100) | .322 | .151 |
| SF‐36; role limitations due to emotional problemsb | 100(100;100)/100(33;100) | 100(100;100)/100(100;100) | 100(67;100)/100(33;100) | 100(100;100)/100(33;100) | .261 | .392 |
| SF‐36; energy/fatigueb | 55(46;65)/55(35;65) | 45(30;70)/45(20;70) | 65(40;90)/65(20;90) | 65(35;85)/70(45;90) | .664 | .431 |
| SF‐36; emotional well‐beingb | 76(68;88)/76(52;88) | 84(64;96)/84(44;96) | 88(68;96)/88(36;96) | 84(68;88)/84(48;88) | .774 | .924 |
| SF‐36; social functioningb | 75(50;100)/75(25;100) | 88(63;100)/88(50;100) | 100(50;100)/100(50;100) | 100(50;100)/100(63;100) | .636 | .392 |
| SF‐36; painb | 68(45;100)/68(33;100) | 58(45;90)/58(45;90) | 78(45;90)/78(23;90) | 78(45;100)/90(58;100) | .943 | .310 |
| SF‐36; general healthb | 51(30;70)/51(5;70) | 50(25;60)/50(15;60) | 45(35;65)/45(20;65) | 50(30;60)/55(25;68) | .909 | .259 |
| FSSb | 4.3(3.5;5.9)/4.3(2.8;5.9) | 5.6(4.2;5.9)/5.6(3.3;5.9) | 4.4(3.9;5.9)/4.4(3.1;5.9) | 4.9(3.0;5.9)/4.2(2.6;4.9) | .303 | .238 |
| BBSb | 41(29;45)/41(25;45) | 37(33;48)/37(28;48) | 43(37;45)/43(30;45) | 45(43;49)/47(43;52) | .021c | .121 |
| CT‐SIB; eyes open, firm surfaceb | .52(.35;.93)/.52(.35;93) | .73(.28;.81)/73(.28;.81) | .60(.37;.76)/.60(.37;.76) | .54(.31;.94)/.54(.31;.98) | .766 | .782 |
| CT‐SIB; eyes closed, firm surfaceb | 1.44(1.17;1.94)/1.44(1.17;1.94) | 1.32(1.27;1.80)/1.32(1.27;1.80) | 1.69(.82;2.21)/1.69(.82;2.21) | 1.48(.78;2.08)/1.35(.78;1.74) | .996 | .996 |
| CT‐SIB; eyes open, foam surfaceb | 1.29(.90;3.42)/1.29(.90;3.42) | 1.40(.88;1.61)/1.40(.88;1.61) | 1.02(.84;1.44)/1.02(.84;1.44) | 1.04(.71;1.18)/.91(.71;1.08) | .205 | .468 |
| CT‐SIB; eyes closed, foam surfaceb | NP | NP | NP | NP | NP | NP |
| PST; overallb | .90(.40;1.80)/.90(.40;1.80) | .70(.40;1.30)/.70(.40;1.30) | .50(.40;.70)/.50(.40;.70) | .50(.40;.70)/.50(.40;.60) | .014d | .023d |
| Fitnessb | NA | 118(96;127)/118(96;127) | 104(99;128)/104(97;115) | 102(98;124)/102(94;120) | .438 | .449 |
ITT, intention‐to‐treat analysis; PP, per protocol analysis; 6MWT, 6‐min walk test (m); SF‐36, short form (36) health survey (score); FSS, fatigue severity scale (score); BBS, Berg balance scale (score); CT‐SIB, clinical test of sensory integration and balance (index); PST, postural stability test (index); NA, not applicable; NP, not possible to complete. Fitness (average heart rate in the fifth minute of moderate‐intensity walking).
Mean ± 1.96 SD.
Median (25th; 75th percentile).
p‐values are for analyses of variance between more than two repeated measurements. Post hoc baseline–posttest; p adjusted = .043, all other comparisons; p adjusted ≥ .104).
Post hoc all comparisons; p adjusted ≥ .178.
Post hoc all comparisons; p adjusted ≥ .120.