Secondary outcomes
| Variable . | Fitbit group (n = 11), mean (SD) . | Standard care group (n = 12), mean (SD) . | Fitbit vs standard care . | |||||
|---|---|---|---|---|---|---|---|---|
| Baseline . | 6 mo . | Within-patient change . | Baseline . | 6 mo . | Within-patient change . | Difference, within-patient change, mean (SD) . | P* . | |
| Coagulation biomarkers | ||||||||
| CRP, mg/dL | 3.74 (1.9) | 3.34 (0.9) | −0.4 (1.6) | 3.43 (1.3) | 3.7 (1.2) | 0.2 (1.5) | −0.6 (1.6) | .462 |
| D-dimer, µg/mL | 4992 (5598) | 317 (52) | −4675 (5633) | 6531 (6455) | 290 (65) | −6241 (6780) | 3087 (6118) | .322 |
| ETP, nM/min | 1704 (335) | 1841 (346) | 41.0 (223) | 2062 (403) | 1962 (440) | −60.1 (148) | 101.1 (183.9) | .439 |
| FVIII, % | 176 (56) | 149 (55) | −39.6 (92) | 238 (77) | 181 (67) | −50.4 (82.5) | 10.8 (88.6) | .808 |
| Lysis 30, % | 3.5 (4.0) | 2.7 (2.3) | −0.05 (3.3) | 4.9 (4.0) | 5.7 (2.8) | 2.1 (3.1) | −2.2 (3.2) | .221 |
| Lysis 60, % | 15.5 (13) | 14 (8.0) | −0.4 (11.6) | 18 (12.4) | 20 (8.7) | 6.2 (6.5) | −6.6 (9.4) | .209 |
| Thrombin peak, nmol/L | 290 (85) | 375 (85) | 60.5 (164) | 381 (80) | 338 (88) | 0.2 (28.4) | 60.3 (118) | .52 |
| Physical activity | ||||||||
| PTS score | 1.4 (0.5) | 1.4 (0.5) | 0.0 (0.50) | 1.2 (0.7) | 2.2 (0.8) | 1.3 (0.8) | −1.3 (0.6) | .0017 |
| Physical activity | 53 (37.6) | 49 (33) | 3.0 (20.6) | 60.7 (40.5) | 71.6 (40) | 8.1 (34.4) | −5.0 (29.5) | .716 |
| QoL, physical | 65 (27.7) | 87 (22) | 11.2 (20.6) | 49.5 (34) | 94 (10) | 38.6 (29.0) | −27.4 (25.5) | .058 |
| QoL, total | 71 (26) | 83 (24) | 5.4 (14.3) | 64 (22) | 87 (12) | 24.5 (14.2) | −19.0 (14.3) | .023 |
| Variable . | Fitbit group (n = 11), mean (SD) . | Standard care group (n = 12), mean (SD) . | Fitbit vs standard care . | |||||
|---|---|---|---|---|---|---|---|---|
| Baseline . | 6 mo . | Within-patient change . | Baseline . | 6 mo . | Within-patient change . | Difference, within-patient change, mean (SD) . | P* . | |
| Coagulation biomarkers | ||||||||
| CRP, mg/dL | 3.74 (1.9) | 3.34 (0.9) | −0.4 (1.6) | 3.43 (1.3) | 3.7 (1.2) | 0.2 (1.5) | −0.6 (1.6) | .462 |
| D-dimer, µg/mL | 4992 (5598) | 317 (52) | −4675 (5633) | 6531 (6455) | 290 (65) | −6241 (6780) | 3087 (6118) | .322 |
| ETP, nM/min | 1704 (335) | 1841 (346) | 41.0 (223) | 2062 (403) | 1962 (440) | −60.1 (148) | 101.1 (183.9) | .439 |
| FVIII, % | 176 (56) | 149 (55) | −39.6 (92) | 238 (77) | 181 (67) | −50.4 (82.5) | 10.8 (88.6) | .808 |
| Lysis 30, % | 3.5 (4.0) | 2.7 (2.3) | −0.05 (3.3) | 4.9 (4.0) | 5.7 (2.8) | 2.1 (3.1) | −2.2 (3.2) | .221 |
| Lysis 60, % | 15.5 (13) | 14 (8.0) | −0.4 (11.6) | 18 (12.4) | 20 (8.7) | 6.2 (6.5) | −6.6 (9.4) | .209 |
| Thrombin peak, nmol/L | 290 (85) | 375 (85) | 60.5 (164) | 381 (80) | 338 (88) | 0.2 (28.4) | 60.3 (118) | .52 |
| Physical activity | ||||||||
| PTS score | 1.4 (0.5) | 1.4 (0.5) | 0.0 (0.50) | 1.2 (0.7) | 2.2 (0.8) | 1.3 (0.8) | −1.3 (0.6) | .0017 |
| Physical activity | 53 (37.6) | 49 (33) | 3.0 (20.6) | 60.7 (40.5) | 71.6 (40) | 8.1 (34.4) | −5.0 (29.5) | .716 |
| QoL, physical | 65 (27.7) | 87 (22) | 11.2 (20.6) | 49.5 (34) | 94 (10) | 38.6 (29.0) | −27.4 (25.5) | .058 |
| QoL, total | 71 (26) | 83 (24) | 5.4 (14.3) | 64 (22) | 87 (12) | 24.5 (14.2) | −19.0 (14.3) | .023 |
Lysis 30% and Lysis 60% are measurements of percent amplitude reduction 30 and 60 minutes after maximum amplitude, respectively, on thromboelastography.
ETP, endogenous thrombin potential.
P value by Student t test.