Table 2.
Outcome Measures by Treatment Group
| Rehabilitation Intervention (n=149) | Attention Control (n=155) | Effect Size (95%CI) | p-value | |||
|---|---|---|---|---|---|---|
| Baseline | Follow-up | Baseline | Follow-up | |||
| 3-month Outcomes | ||||||
| SPPB Score (Primary Outcome) | 6.0±2.8 | 8.3±0.2 | 6.1±2.5 | 6.9±0.2 | 1.5 (0.9, 2.0) | <0.0001 |
| Balance Score | 2.6±1.3 | 3.2±0.1 | 2.7±1.3 | 2.9±0.1 | 0.4 (0.1, 0.6) | 0.007 |
| 4-meter Walk Score | 2.3±1.0 | 3.0±0.1 | 2.3±1.0 | 2.5±0.1 | 0.5 (0.2, 0.7) | <0.0001 |
| Chair Rise Score | 1.1±1.2 | 2.1±0.1 | 1.2±1.2 | 1.5±0.1 | 0.6 (0.4, 0.9) | <0.0001 |
| 6 Minute Walk Distance (m) | 194±104 | 293±8 | 193±107 | 260±8 | 34 (11, 56) | 0.003 |
| Gait Speed (m/s) | 0.60±0.23 | 0.80±0.02 | 0.61±0.22 | 0.68±0.02 | 0.12 (0.07, 0.16) | <0.0001 |
| Handgrip Strength (kg) | ||||||
| Men | 30.3±9.5 | 30.1±0.7 | 30.5±10.7 | 30.6±0.7 | -0.5 (−2.6, 1.7) | 0.67 |
| Women | 20.7±7.3 | 21.2±0.6 | 19.6±6.6 | 21.4±0.6 | -0.1 (−1.7, 1.5) | 0.88 |
| Modified Fried Frailty Criteria*, # | 2.3±1.1 | 1.4±0.1 | 2.4±1.1 | 1.6±0.1 | -0.3 (−0.5, −0.0) | 0.033 |
| KCCQ Overall Score | 40±21 | 69±2 | 42±21 | 62±2 | 7 (2, 12) | 0.007 |
| EuroQol Visual Analogue Scale | 58±22 | 71±2 | 58±21 | 64±2 | 7 (3, 12) | 0.003 |
| Cognition (MoCA Score) | 21.9±4.2 | 22.2±0.3 | 21.8±4.6 | 22.5±0.3 | -0.2 (−1.1, 0.6) | 0.56 |
| Depression (GDS-15 Score) | 4.6±3.3 | 3.3±0.2 | 4.7±3.3 | 4.1±0.2 | -0.7 (−1.3, −0.1) | 0.018 |
| 6-month Clinical Events | Rehabilitation Intervention (n=174) | Attention Control (n=173) | Effect Size (95%CI) | p-value | ||
| All-cause rehospitalizations at 6 months follow-up, rate (Secondary Outcome) | 1.22 (1.04, 1.43) | 1.35 (1.15, 1.57) | 0.90 (0.74, 1.10) | 0.32 | ||
| Deaths, rate | 0.11 (0.07, 0.19) | 0.09 (0.05, 0.16) | 1.17 (0.61, 2.27) | 0.63 | ||
| Combined all-cause rehospitalizations and death at 6 months, rate | 1.36 (1.17, 1.59) | 1.47 (1.27, 1.70) | 0.93 (0.77, 1.12) | 0.44 | ||
| Heart failure rehospitalizations, rate | 0.59 (0.46, 0.75) | 0.69 (0.55, 0.87) | 0.85 (0.65, 1.13) | 0.26 | ||
| Patients with ≥2 all-cause rehospitalizations, proportion | 0.29 (0.22, 0.38) | 0.37 (0.29, 0.46) | 0.71 (0.44, 1.13) | 0.14 | ||
| Patients with ≥2 heart failure rehospitalizations, proportion | 0.12 (0.07, 0.20) | 0.15 (0.09, 0.24) | 0.78 (0.41, 1.46) | 0.43 | ||
| All-cause rehospitalization days | 8.9 (6.2, 12.7) | 9.1 (6.6, 12.6) | 0.98 (0.64, 1.49) | 0.92 | ||
| Patients with ≥1 fall, proportion | 0.25 (0.18, 0.34) | 0.34 (0.26, 0.43) | 0.67 (0.42, 1.06) | 0.09 | ||
| Patients with ≥1 injurious fall, proportion | 0.06 (0.03, 0.12) | 0.09 (0.05, 0.15) | 0.66 (0.30, 1.47) | 0.31 | ||
Baseline data presented as means±SD. Follow-up data presented as LSmeans±SE adjusted for baseline value, clinical site, age, sex, and EF category. Clinical event data presented as LSmeans (95% CI) of rate (counts per patient) or proportion of patients adjusted for clinical site, age, sex, and EF category. All-cause rehospitalization at 6 months also adjusted for baseline SPPB score. Clinical event effect sizes of rates are shown as rate ratios and proportions are shown as odds ratios. KCCQ and Visual Analogue Scale scores range 0–100, with higher score meaning better health status. MoCA score ranges 0–30 with higher score meaning better cognitive function. GDS-15 score ranges 0–15 with higher score meaning worse depressive symptoms. Abbreviations: SPPB: short physical performance battery; KCCQ: Kansas City Cardiomyopathy Questionnaire; MoCA: Montreal Cognitive Assessment; GDS-15: Geriatric Depression Scale.
Modified Fried Frailty Criteria excludes weight loss criteria due to difficulty in ascertaining weight changes due to fluid status.