Table 3.
Analysis of 3-month Functional Outcomes and 6-month Clinical Outcomes by Heart Failure Phenotype: HFpEF vs. HFrEF.
| HFpEF | HFrEF | P-value for interaction | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 3-month Functional Outcomes | Rehabilitation Intervention | Attention Control | Effect Size | p-value | Rehabilitation Intervention | Attention Control | Effect Size | p-value | |
| SPPB Score | 8.3±0.3 | 6.4±0.3 | 1.9 (1.1, 2.6) | <0.001 | 8.4±0.3 | 7.3±0.3 | 1.1 (0.3, 1.9) | 0.009 | 0.20 |
| Balance Score | 3.2±0.1 | 2.6±0.1 | 0.6 (0.3, 1.0) | <0.001 | 3.3±0.1 | 3.1±0.1 | 0.1 (−0.2, 0.5) | 0.49 | 0.06 |
| 4-meter Walk Score | 2.9±0.1 | 2.4±0.1 | 0.5 (0.2, 0.8) | 0.002 | 3.1±0.1 | 2.6±0.1 | 0.5 (0.2, 0.8) | 0.003 | 0.95 |
| Chair Rise Score | 2.1±0.1 | 1.4±0.1 | 0.8 (0.4, 1.1) | <0.001 | 2.1±0.1 | 1.7±0.1 | 0.4 (0.1, 0.8) | 0.021 | 0.20 |
| 6 Minute Walk Distance (m) | 295±11 | 255±12 | 40 (9, 72) | 0.012 | 291±12 | 264±11 | 27 (−6, 59) | 0.11 | 0.54 |
| Gait Speed (m/s) | 0.79±0.02 | 0.68±0.02 | 0.11 (0.05, 0.18) | <0.001 | 0.81±0.02 | 0.69±0.02 | 0.12 (0.06, 0.18) | <0.001 | 0.93 |
| Modified Fried Frailty Criteria* | 1.5±0.1 | 1.7±0.1 | −0.3 (−0.6, 0.1) | 0.11 | 1.2±0.1 | 1.5±0.1 | −0.3 (−0.7, 0.1) | 0.10 | 0.93 |
| KCCQ Overall | 68±2 | 59±3 | 9 (2, 16) | 0.014 | 70±3 | 64±3 | 6 (−2, 14) | 0.13 | 0.59 |
| KCCQ Clinical | 67±2 | 61±3 | 7 (−0, 14) | 0.06 | 70±3 | 66±3 | 5 (−3, 12) | 0.24 | 0.67 |
| EuroQol Visual Analogue Scale | 72±2 | 63±2 | 9 (3, 16) | 0.004 | 71±3 | 66±3 | 4 (−3, 11) | 0.23 | 0.29 |
| Cognition (MoCA Score) | 22.6±0.4 | 22.8±0.4 | −0.2 (−1.3, 1.0) | 0.77 | 21.8±0.4 | 22.1±0.4 | −0.4 (−1.6, 0.8) | 0.56 | 0.81 |
| Depression (GDS-15 Score) | 3.3±0.3 | 4.1±0.3 | −0.9 (−1.7, −0.0) | 0.043 | 3.4±0.3 | 4.1±0.3 | −0.7 (−1.6, 0.3) | 0.16 | 0.76 |
| 6-month Clinical Outcomes | |||||||||
| All-cause rehospitalizations, rate | 1.20 (0.98, 1.48) | 1.44 (1.19, 1.75) | 0.83 (0.64, 1.09) | 0.18 | 1.22 (0.97, 1.54) | 1.23 (0.98, 1.54) | 0.99 (0.74, 1.33) | 0.95 | 0.40 |
| Heart failure rehospitalizations, rate | 0.51 (0.37, 0.70) | 0.65 (0.48, 0.87) | 0.79 (0.53, 1.17) | 0.24 | 0.66 (0.48, 0.91) | 0.72 (0.53, 0.98) | 0.92 (0.62, 1.35) | 0.66 | 0.60 |
| All-Cause Rehospitalization and Death, rate | 1.31 (1.07, 1.60) | 1.59 (1.32, 1.90) | 0.82 (0.64, 1.06) | 0.13 | 1.38 (1.11, 1.72) | 1.31 (1.05, 1.63) | 1.06 (0.80, 1.40) | 0.70 | 0.20 |
| Deaths, rate | 0.08 (0.04, 0.17) | 0.12 (0.06, 0.23) | 0.63 (0.25, 1.61) | 0.34 | 0.13 (0.06, 0.25) | 0.06 (0.02, 0.15) | 2.21 (0.78, 6.25) | 0.14 | 0.08 |
| Patients with ≥2 all-cause rehospitalizations, proportion | 0.33 (0.21, 0.54) | 0.63 (0.41, 0.97) | 0.53 (0.28, 1.01) | 0.06 | 0.38 (0.23, 0.63) | 0.41 (0.25, 0.68) | 0.92 (0.46, 1.85) | 0.82 | 0.26 |
| Patients with ≥2 HF rehospitalizations, proportion | 0.08 (0.04, 0.18) | 0.13 (0.07, 0.26) | 0.63 (0.24, 1.66) | 0.35 | 0.16 (0.09, 0.31) | 0.18 (0.10, 0.34) | 0.89 (0.38, 2.1) | 0.78 | 0.61 |
| All-cause rehospitalization days | 7.5 (4.9, 11.3) | 8.4 (5.5. 12.8) | 0.89 (0.50, 1.59) | 0.70 | 8.7 (5.5, 13.5) | 8.1 (5.3, 12.5) | 1.06 (0.58, 1.94) | 0.84 | 0.68 |
| Patients with ≥1 fall, proportion | 0.37 (0.23, 0.59) | 0.53 (0.34, 0.82) | 0.70 (0.37, 1.33) | 0.28 | 0.34 (0.20, 0.57) | 0.61 (0.38, 0.97) | 0.56 (0.28, 1.12) | 0.10 | 0.65 |
| Patients with ≥1 injurious fall, proportion | 0.07 (0.03, 0.17) | 0.10 (0.05, 0.21) | 0.75 (0.25, 2.20) | 0.60 | 0.05 (0.02, 0.14) | 0.09 (0.04, 0.20) | 0.61 (0.18, 2.05) | 0.43 | 0.81 |
3-month follow-up data presented as LS means±SE adjusted for baseline value, clinical site, age, sex, diabetes, and BMI. 6-month clinical event data presented as LS means (95% CI) of rate for count-based data or proportion of patients for frequency data, adjusted for clinical site, age, sex, diabetes, and BMI. All-cause rehospitalization at 6 months also adjusted for baseline SPPB score. Effect sizes shown with 95% CIs. For clinical outcomes based on counts, effect sizes shown as rate ratios. For clinical outcomes based on proportions, effect sizes shown as odds ratios.
KCCQ 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: Geriatric Depression Scale.
Modified Fried Frailty Criteria excludes weight loss criteria due to difficulty in ascertaining weight changes due to fluid status.