Background
Methods
Study design and setting
Participant screening and recruitment
Outcomes and testing procedures
Preliminary analyses
Analyses of thresholds
Results
Randomised cohort n = 166 | Observational cohort n = 77 | Entire cohort n = 243 | |
---|---|---|---|
Age, yrs, mean (sd) | 67.0 (8.3) | 66.7 (8.7) | 66.9 (8.4) |
Gender, female, n (%) | 112 (68) | 35 (45) | 147 (61) |
Body mass index, mean (sd) | 34.7 (7.0) | 33.0 (7.2) | 34.2 (7.1) |
Baseline 6-min walk test, mean (sd) | 319.1 (109.1) | 329.5 (114.0) | 322.4 (110.6) |
Baseline Oxford Knee Score | 17.0 (7.1) | 17.6 (7.7) | 17.2 (7.3) |
Comorbidity, yes, n (%) | 127 (77) | 53 (69) | 180 (75) |
Cardiovascular | 116 (70) | 47 (61) | 163 (67) |
Gastrointestinal | 53 (32) | 11 (14) | 64 (26) |
Other lower limb or back | 43 (26) | 21 (27) | 64 (26) |
Diabetes Mellitus | 38 (23) | 18 (23) | 56 (23) |
Respiratory | 21 (13) | 10 (13) | 31 (13) |
Growth curve analyses
Anchor-based estimation of improvement thresholds
Correlation of the transition scale with measured change
Change in 6MWT | Rating on transition scale | ||
---|---|---|---|
Baseline to 10-weeks | Baseline to 26-weeks | 10-weeks to 26-weeks | |
Absolute Baseline to 10-weeks | 0.297 (p < 0.001) | NA | NA |
n = 156 | |||
Relative Baseline to 10-weeks | 0.259 (p < 0.001) | NA | NA |
n = 156 | |||
Absolute Baseline to 26-weeks | NA | 0.259 (p < 0.001) | NA |
n = 211 | |||
Relative Baseline to 26-weeks | NA | 0.239 (p < 0.001) | NA |
n = 211 | |||
Absolute10-weeks to 26-weeks | NA | NA | 0.03 (p = 0.73) |
n = 139 | |||
Relative 10-weeks to 26-weeks | NA | NA | 0.054 (p = 0.526) |
n = 139 |
Categorisation of improved versus not improved participants
Important change | Max negative and positive changes in distancea | AUC (95 % CI) | Youden’s method | Sensitivity (95 % CI)b | Specificity (95 % CI)b | 80 % Specificity method | Sensitivity (95 % CI)b | Specificity (95 % CI)b |
---|---|---|---|---|---|---|---|---|
10 weeks Absolute | ||||||||
Slight or more (n = 140) | −148.0 m to 290.0 m | 70.1 % (55.58, 84.7) | 11.5 m | 70.2 (62.41, 78.39) | 66.7 (40, 86.67) | 53.0 m | 48.9 (41.13, 57.45) | 80.0 (60, 100) |
Moderate or more (n = 128) | −148.0 m to 290.0 m | 72.3 % (51.15, 83.35) | 11.5 m | 74.4 (66.67, 82.95) | 70.4 (51.85, 85.19) | 53.0 m | 51.9 (42.64, 60.47) | 81.4 (66.67, 92.59) |
Much better (n = 85) | −148.0 m to 252.0 m | 62.8 % (53.85, 71.78) | 11.5 m | 79.1 (70.93, 87.21) | 48.6 (36.39, 60) | 106.5 m | 29.1 (19.16, 38.37) | 80.0 (71.43, 88.57) |
10 weeks Relative | ||||||||
Slight or more (n = 140) | −92.6 to 486.0 % | 67.3 % (51.21, 83.44) | 5.1 % | 66.7 (58.16, 74.13) | 66.7 (40, 86.67) | 15.1 % | 49.7 (40.43, 58.16) | 80.0 (60, 100) |
Moderate or more (n = 128) | −92.6 to 486.0 % | 70.7 % (59.05, 82.32) | 5.1 % | 70.5 (62.02, 78.29) | 70.4 (51.85, 85.19) | 15.5 % | 48.8 (40.31, 56.59) | 81.5 (66.67, 94.54) |
Much better (n = 85) | −92.6 to 486.0 % | 60.7 % (51.53, 69.9) | 5.7 % | 54.3 (44.29, 65.71) | 70.5 (63.95, 83.17) | 49.1 % | 23.3 (15.12, 32.56) | 80.0 (70.68, 88.57) |
26 weeks Absolute | ||||||||
Slight or more (n = 188) | −242.3 m to 370.0 m | 72.4 % (62.05, 82.7) | 26 m | 72.9 (66.21, 79.26) | 65.2 (45.54, 82.61) | 64.5 m | 50.0 (43.09, 56.91) | 82.6 (67.28, 95.65) |
Moderate or more (n = 179) | −242.3 m to 370.0 m | 70.6 % (60.33, 80.94) | 6.5 m | 81.6 (75.98, 87.15) | 56.3 (38.98, 71.88) | 71.0 m | 48.0 (41.05, 55.31) | 81.3 (67.28, 95.65) |
Much better (n = 143) | −194.0 m to 370.0 m | 64.7 % (56.59, 72.77) | 8.5 m | 84.4 (78.01, 90.07) | 41.4 (31.43, 54.29) | 110.5 m | 35.5 (27.66, 43.63) | 81.4 (72.86, 90) |
26 weeks Relative | ||||||||
Slight or more (n = 188) | −93 to 515.2 % | 71.7 % (60.64, 82.79) | 11.3 % | 65.4 (58.51, 72.09) | 73.9 (56.52, 89.24) | 18.3 % | 52.1 (45.74, 59.04) | 82.6 (67.28, 95.65) |
Moderate or more (n = 179) | −93.2 to 515.2 % | 69.6 % (58.74, 80.4) | 1.5 % | 82.1 (76.54, 87.71) | 56.3 (37.5, 71.88) | 27.9 % | 40.78 (33.78, 48.6) | 81.3 (65.62, 93.75) |
Much better (n = 143) | −91.3 to 515.2 % | 63.4 % (55.07, 71.78) | 1.54 % | 85.1 (79.06, 90.78) | 41.4 (30, 52.86) | 61.0 % | 21.3 (14.18, 27.66) | 84.3 (74.29, 84.29) |