Background
Methods
Study design
Study population, screening and randomization
Interventions
Outcomes
Harms
Statistical analysis
Results
Characteristics of the study population
Intervention group (n = 120) | Control group (n = 121) |
P
a
| |
---|---|---|---|
Characteristic | |||
Male (%) | 39 (33%) | 39 (32%) | 0.96 |
Age (year) | 83.4 ±5.81 | 83.2 ±5.91 | 0.80 |
Lives alone (%) | 60 (50%) | 51 (42%) | 0.22 |
Number of frailty criteria presentb (%) | 0.84 | ||
Three | 77 (64%) | 79 (65%) | |
Four | 33 (28%) | 30 (25%) | |
Five | 10 (8%) | 12 (10%) | |
Weight | 68.5 (15.7) | 69.3 (17.3) | 0.70 |
Exhaustion (%) | 77 (64%) | 76 (63%) | 0.83 |
Grip strength (kg) | 15.8 (7.2) | 15.3 (7.2) | 0.70 |
Gait speed (m/s) | 0.48 (0.18) | 0.50 (0.17) | 0.32 |
Low physical activity (%) | 73 (61%) | 83 (69%) | 0.21 |
Frailty, mean Cardiovascular Health Study score
Health status
| 3.44 (0.65) | 3.45 (0.67) | 0.96 |
Coexisting conditionsc
| 5.87 ±2.33 | 5.75 ±2.24 | 0.70 |
Body mass index (kg/m2) | 26.1 ±5.91 | 26.4 ±6.04 | 0.67 |
Geriatric Depression Scaled,e
| 4.76 ±3.18 | 5.06 ±3.19 | 0.47 |
Mini Mental State Examinationd,e
| 26.6 ±2.59 | 25.9 ±3.14 | 0.07 |
Functioning
| |||
Disability, Barthel Indexe
| 93.9 ±11.1 | 92.5 ±14.3 | 0.40 |
Mobility, Short Physical Performance Batterye
| 5.21 ±1.89 | 5.74 ±2.12 | 0.04 |
Mobility, lower extremity continuous summary performance scoree
| 1.74 ±0.43 | 1.86 ±0.45 | 0.05 |
Health-related quality of life, EuroQol-5De
| 7.67 ±1.47 | 7.83 ±1.50 | 0.39 |
Health-related quality of life, EuroQol-5D VASe
| 58.2 ±15.8 | 57.9 ±18.4 | 0.90 |
Primary outcomes
Intervention group | Control group | Percentage difference between groups or coefficienta
|
P
b
| |
---|---|---|---|---|
Primary outcomes | ||||
Frailty
c
| ||||
3 months (number (%)) | 69 out of 108 (64%) | 88 out of 117 (75%) | -11.3% (-23.3% to 0.7%) | 0.07 |
12 months (number (%)) | 66 out of 107 (62%) | 81 out of 106 (76%) | -14.7% (-27.0% to -2.4%) | 0.02 |
Change from 0 to 3 months | 108, 0.56 ±1.10 | 117, 0.39 ±0.92 | -0.18 (-0.43 to 0.08) | 0.17 |
Change from 0 to 12 months | 107, 0.80 ±1.19 | 106, 0.41 ±1.02 | -0.41 (-0.68 to -0.14) | <0.01 |
Mobility, Short Physical Performance Battery
c
| ||||
3-month mean 12-month mean Change from 0 to 3 months Change from 0 to 12 months | 107, 5.40 ±2.32 107, 5.83 ±2.82 107, -0.15 ±1.89 107, -0.52 ±2.47 | 116, 5.72 ±2.30 108, 4.69 ±2.91 116, 0.01 ±1.72 108, 0.98 ±2.30 | 0.05 (-0.42 to 0.51) 1.44 (0.80 to 2.07) | 0.85 <0.001 |
Mobility, lower extremity continuous summary performance score
c
| ||||
3-month mean 12-month mean Change from 0 to 3 months Change from 0 to 12 months | 107, 1.72 ±0.57 107, 1.77 ±0.59 107, 0.04 ±0.49 107, 0.00 ±0.50 | 116, 1.80 ±0.52 108, 1.49 ±0.75 116, 0.06 ±0.38 108, 0.35 ±0.63 | -0.00 (-0.12 to 0.11) 0.34 (0.19 to 0.49) | 0.96 <0.001 |
Secondary outcomes
| ||||
Barthel Index
c
| ||||
3-month mean 12-month mean Change from 0 to 3 months Changes from 0 to 12 months | 108, 94.2 ±11.2 106, 89.5 ±17.5 108, 0.56 ±7.92 106, 5.56 ±14.61 | 117, 93.2 ±13.9 108, 86.1 ±24.7 116, -0.80 ±10.87 107, 6.14 ±20.76 | -0.68 (-3.05 to 1.68) 0.67 (-4.23 to 5.56) | 0.57 0.79 |
Geriatric Depression Scale
c
| ||||
3-month mean 12-month mean Change from 0 to 3 months Change from 0 to 12 months | 108, 4.89 ±3.14 106, 4.62 ±3.33 108, -0.19 ±2.30 106, 0.11 ±2.27 | 117, 4.90 ±3.24 108, 4.98 ±3.16 117, 0.13 ±2.52 108, 0.02 ±2.90 | 0.22 (-0.37 to 0.82) -0.18 (-0.83 to 0.47) | 0.46 0.59 |
EQ5D VAS
c
| ||||
3-month mean 12-month mean Change from 0 to 3 months Change from 0 to 12 months | 108, 60.6 ±20.1 107, 57.5 ±20.8 108, -1.81 ±15.65 107, 0.41 ±18.93 | 117, 60.3 ±16.9 108, 57.7 ±19.7 117, -1.96 ±16.77 108, 1.12 ±20.62 | 0.04 (-3.93 to 4.00) 0.30 (-4.59 to 5.18) | 0.99 0.91 |
Secondary outcomes
Number | Intervention group (n = 120) | Control group (n = 121) | Percentage difference between groups or coefficienta
|
P
b
| |
---|---|---|---|---|---|
Frailty criteria | |||||
Weight (kg)
| |||||
Change from 0 to 3 months | 224 | 0.40 ±3.72 | 0.92 ±3.59 | 0.51 (-0.45 to 1.48) | 0.29 |
Change from 0 to 12 months | 210 | 0.72 ±5.98 | 1.48 ±5.09 | 0.78 (-0.72 to 2.28) | 0.31 |
Exhaustion
| |||||
Rate at 3 months (number (%)) | 225 | 47 (44%) | 46 (39%) | 4.2% (-8.7% to 17.1%) | 0.52 |
Rate at 12 months (number (%)) | 213 | 29 (27%) | 35 (33%) | -5.9% (-18.2% to 6.4%) | 0.35 |
Grip strength (kg)
| |||||
Change from 0 to 3 months | 225 | 0.78 ±3.56 | 1.02 ±4.93 | 0.50 (-0.55 to 1.54) | 0.35 |
Change from 0 to 12 months | 213 | 0.93 ±4.62 | 1.88 ±5.75 | 1.18 (-0.13 to 2.49) | 0.08 |
Gait speed (meter/second)
| |||||
Change from 0 to 3 months | 225 | -0.006 ±0.155 | -0.007 ±0.169 | -0.004 (-0.046 to 0.039) | 0.87 |
Change from 0 to 12 months | 213 | -0.049 ±0.183 | 0.019 ±0.230 | 0.068 (0.012 to 0.123) | 0.02 |
Low physical activity
| |||||
Rate at 3 months - No. (%)
| 225 | 59 (55%) | 74 (63%) | -8.6% (-21.4% to 4.2%) | 0.19 |
Rate at 12 months - No. (%)
| 213 | 67 (63%) | 80 (76%) | -12.9% (-25.2% to -0.6%) | 0.04 |
Number | Intervention group (n = 120) | Control group (n = 121) | Coefficienta
|
P
b value | |
---|---|---|---|---|---|
Short Physical Performance Battery criteria | |||||
Balance score
| |||||
Change from 0 to 3 months | 223 | 0.19 ±1.13 | 0.21 ± 1.02 | -0.06 (-0.32 to 0.20) | 0.63 |
Change from 0 to 12 months | 215 | -0.11 ±1.24 | 0.59 ±1.25 | 0.63 (0.32 to 0.95) | <0.001 |
Measured walks score
| |||||
Change from 0 to 3 months | 223 | -0.07 ±0.80 | -0.08 ±0.80 | -0.02 (-0.22 to 0.18) | 0.82 |
Change from 0 to 12 months | 215 | -0.27 ±0.90 | 0.08 ±0.96 | 0.35 (0.10 to 0.59) | 0.006 |
Chair stands score
| |||||
Change from 0 to 3 months | 223 | -0.26 ±0.94 | -0.12 ±0.87 | 0.04 (-0.18 to 0.27) | 0.72 |
Change from 0 to 12 months | 215 | -0.14 ±1.22 | 0.31 ±0.98 | 0.33 (0.07 to 0.59) | 0.01 |
Adherence | |||||
---|---|---|---|---|---|
Outcomea
| <25% (n = 42) | 25% to 49% (n = 17) | 50% to 74% (n = 23) | 75% to 100% (n = 24) |
P
|
Frailty | 3.24 (2.95 to 3.53) | 2.23 (1.76 to 2.70) | 2.28 (1.88 to 2.68) | 2.12 (1.74 to 2.51) | <0.001 |
Short Physical Performance Battery | 4.83 (4.14 to 5.53) | 5.58 (4.47 to 6.69) | 6.14 (5.21 to 7.08) | 7.43 (6.53 to 8.34) | <0.001 |
Lower extremity continuous summary performance score | 1.59 (1.44 to 1.73) | 1.74 (1.50 to 1.97) | 1.91 (1.71 to 2.11) | 1.96 (1.77 to 2.15) | 0.01 |
Barthel Index | 86.3 (81.8 to 90.8) | 91.0 (83.8 to 98.2) | 94.0 (87.9 to 100) | 91.4 (85.5 to 97.4) | 0.21 |
Geriatric Depression Scale | 5.44 (4.78 to 6.11) | 4.16 (3.09 to 5.23) | 4.32 (3.42 to 5.22) | 3.95 (3.07 to 4.83) | 0.03 |
Health-related quality of life (EuroQol-5D visual analog scale) | 52.2 (46.9 to 57.6) | 51.2 (42.6 to 59.8) | 60.0 (52.8 to 67.2) | 69.4 (62.3 to 76.4) | 0.001 |