| . | ARIS group (n = 19) . | AT/IMT group (n = 20) . | AT/RT group (n = 17) . | AT group (n = 18) . | ||||
|---|---|---|---|---|---|---|---|---|
| CPX parameters (primary endpoint: peakVO2) . | ||||||||
| Baseline . | 12 weeks . | Baseline . | 12 weeks . | Baseline . | 12 weeks . | Baseline . | 12 weeks . | |
| peakVO2 (mL/kg/min) | 17.4 (15.2–19.5) | 20.4 (18.3–22.6)**** | 16.6 (15–18.3) | 18.3 (16.6–20)** | 17.4 (15.6–19.3) | 18.8 (17.1–20.5)* | 18 (15.9–20) | 19.5 (17.4–21.7)* |
| Exercise time (min) | 9.0/9 (7.89–10.3) | 11.1 (9.94–12.2)**** | 8.08 (6.76–9.4) | 9.58 (8.43–10.7)*** | 8.19 (6.86–9.52) | 9.46 (8.46–10.4)** | 8.9 (8.29–9.5) | 9.39 (8.66–10.1) |
| VE/CO2 slope | 37.5 (34–41.1) | 35.2 (32.5–37.8)* | 34.6 (31.7–37.5) | 34.8 (31.6–38) | 36.3 (32.1–40.4) | 33.4 (30.4–36.4) | 34.2 (31.5–36.9) | 33.8 (31.1–36.4) |
| VT (mL/kg/min) | 15.4 (13.4–17.5) | 17.4 (15–19.8)** | 14 (12.5–15.5) | 15.2 (13.4–17) | 16 (14.2–17.8) | 16.6 (14.8–18.4) | 15.3 (13–17.7) | 16.7 (14.4–19)** |
| VE (L/min) | 53.4 (45.4–61.4) | 62.6 (53.8–71.4)* | 59.1 (48.5–69.8) | 69.5 (59.7–79.3)** | 53 (47.7–58.3) | 57.1 (49.4–64.8) | 57.3 (50.5–64.1) | 61.7 (54.7–68.7)* |
| RER | 1.05 (1–1.1) | 1.06 (1.03–1.1) | 1.05 (0.988–1.12) | 1.08 (1.01–1.14) | 1.04 (0.958–1.13) | 1.06 (0.983–1.13) | 1.1 (1.07–1.13) | 1.11 (1.03–1.18) |
| HRrest (b.p.m) | 76.7 (70.5–83) | 72.6 (68.6–76.6) | 70.4 (65.1–75.7) | 66.4 (62.9–69.8) | 72.8 (68.5–77) | 70 (67–73)* | 64.8 (57–72.6) | 65.8 (57.5–74.2) |
| HRpeak (b.p.m) | 130 (117.6–142.4) | 135.2 (125.4–144.9) | 123.4 (113.5–133.4) | 123 (113–133.1) | 126.2 (115.5–137) | 130.4 (121.7–139) | 135.5 (126.4–144.6) | 134.8 (125.3–144.4) |
| SBPrest (mmHg) | 111.3 (103.9–118.7) | 108.3 (99.94–116.6) | 108.4 (100.4–116.3) | 108.2 (101.7–114.8) | 113.6 (106.3–120.9) | 109 (102.7–115.3) | 113.1 (105.4–120.8) | 108.6 (102.1–115.1) |
| SBPpeak (mmHg) | 152.8 (144.8–160.8) | 161.9 (152.4–171.4)*** | 151.5 (138.6–164.4) | 150.6 (138.9–162.4) | 144.7 (133.3–156.1) | 150.2 (140.9–159.6) | 150.3 (138.2–162.4) | 153.4 (142.7–164.1) |
| CP (mL/kg/min⋅mmHg) | 2650 (2306–2995) | 3282 (2890–3673)**** | 2568 (2169–2968) | 2799 (2409–3188) | 2543 (2181–2905) | 2828 (2511–3145)* | 2719 (2235–3203) | 2986 (2618–3355)* |
| Echocardiography parameters (primary endpoints: LVEDD, LVESD) | ||||||||
| LVEF (%) | 28.3 (25.9–30.7) | 29.9 (27.4–32.4)*** | 28.8 (25.1–32.5) | 31.6 (27.7–35.4)** | 29.6 (27.2–32.1) | 31.5 (28.9–34.1)** | 26.8 (24.7–28.8) | 29.1 (25.7–32.4)* |
| LVEDD (mm) | 65.3 (61.9–68.7) | 63.9 (60.6–67.2)** | 65.6 (61.4–69.9) | 63.8 (59.6–68.1)* | 64.4 (60.8–67.9) | 63 (59.9–66.1)** | 66.7 (64–69.5) | 65.6 (62.8–68.4)** |
| LVESD (mm) | 55.1 (50.8–59.3) | 52.5 (48.6–56.3)*** | 55.9 (51.5–60.3) | 54.4 (49.8–58.9)* | 54 (49.2–58.8) | 53.6 (48.7–58.5) | 59 (55.9–62.1) | 58.7 (55.8–61.5) |
| Secondary endpoints and other study outcomes | ||||||||
| PImax (cmH2O) | 82.6 (73.9–91.3) | 112 (102–122)**** | 85.6 (75.6–95.5) | 108 (99.7–117)**** | 79.8 (70.3–89.4) | 80.4 (71.2–89.5) | 83.1 (75.3–90.8) | 87 (78.4–95.6)** |
| SPImax (cmH2O s−1⋅10−3) | 308.2 (296.5–319.9) | 412.9 (401.3–424.5)**** | 303.6 (291.8–315.4) | 413.6 (396.3–430.9)**** | 315.3 (296.6–334) | 310.9 (295.3–326.5) | 313.3 (297.8–328.9) | 312.8 (295.2–330.3) |
| QMS (kg) | 23.5 (20.2–26.7) | 29.8 (26.2–33.3)**** | 21.3 (18.5–24.1) | 21.6 (18.7–24.5) | 23.2 (19.6–26.8) | 30.1 (26.2–34.1)**** | 22.1 (18.7–25.5) | 21.9 (18.8–25) |
| QME (kg⋅max reps) | 151.6 (128.9–174.3) | 207 (178.4–235.7)**** | 149 (124.4–173.7) | 153.8 (127.7–180) | 147.9 (123.1–172.6) | 216.6 (186.3–246.9)**** | 144.4 (124.8–164) | 152.8 (134.2–171.4)* |
| 6 min walk test (m) | 470.4 (438.8–501.9) | 542.6 (509.1–576.1)**** | 424.6 (397.5–451.6) | 452.2 (416.2–488.2)* | 478.7 (444.4–513.1) | 553.1 (518.7–587.5)**** | 437.7 (403.9–471.4) | 455.5 (413.1–497.9)* |
| Dyspnoea6mwt (Borg. 0–10) | 3.8 (3.2–4.5) | 2.9 (2.5–3.3)**** | 4.2 (3.5–4.8) | 2.4 (2.1–2.8)**** | 3.2 (2.6–3.8) | 2.5 (1.8–3.1)** | 4.1 (3.4–4.7) | 4.2 (3.6–4.9) |
| DyspnoeaCPX (Borg. 0–10) | 8.4 (8.2–8.7) | 7.7 (7.4–8)*** | 8.5 (8.3–8.7) | 8 (7.6–8.3)** | 8.4 (8.1–8.6) | 8.6 (8.3–8.9) | 8.2 (7.9–8.5) | 8.3 (7.9–8.6) |
| NYHA | 2.5 (2.3–2.8) | 1.9 (1.6–2.2)**** | 2.4 (2.1–2.6) | 2 (1.7–2.2)* | 2.3 (2.1–2.5) | 2.1 (1.8–2.3)* | 2.4 (2.1–2.6) | 2.1 (1.7–2.5)* |
| MLwHFQ | 40.9 (37.3–44.6) | 31.4 (27.9–34.9)**** | 41 (37.1–44.9) | 32.2 (28.8–35.7)**** | 41.3 (37.6–45) | 39.5 (35.2–43.8)* | 41.6 (38.3–44.9) | 40.9 (37.6–44.2) |
| PPS (1–5) | 4.8 (4.7–5.0)§ | 4.6 (4.3–4.8) | 4.5 (4.1–4.8) | 4.4 (4.2–4.7) | ||||
| . | ARIS group (n = 19) . | AT/IMT group (n = 20) . | AT/RT group (n = 17) . | AT group (n = 18) . | ||||
|---|---|---|---|---|---|---|---|---|
| CPX parameters (primary endpoint: peakVO2) . | ||||||||
| Baseline . | 12 weeks . | Baseline . | 12 weeks . | Baseline . | 12 weeks . | Baseline . | 12 weeks . | |
| peakVO2 (mL/kg/min) | 17.4 (15.2–19.5) | 20.4 (18.3–22.6)**** | 16.6 (15–18.3) | 18.3 (16.6–20)** | 17.4 (15.6–19.3) | 18.8 (17.1–20.5)* | 18 (15.9–20) | 19.5 (17.4–21.7)* |
| Exercise time (min) | 9.0/9 (7.89–10.3) | 11.1 (9.94–12.2)**** | 8.08 (6.76–9.4) | 9.58 (8.43–10.7)*** | 8.19 (6.86–9.52) | 9.46 (8.46–10.4)** | 8.9 (8.29–9.5) | 9.39 (8.66–10.1) |
| VE/CO2 slope | 37.5 (34–41.1) | 35.2 (32.5–37.8)* | 34.6 (31.7–37.5) | 34.8 (31.6–38) | 36.3 (32.1–40.4) | 33.4 (30.4–36.4) | 34.2 (31.5–36.9) | 33.8 (31.1–36.4) |
| VT (mL/kg/min) | 15.4 (13.4–17.5) | 17.4 (15–19.8)** | 14 (12.5–15.5) | 15.2 (13.4–17) | 16 (14.2–17.8) | 16.6 (14.8–18.4) | 15.3 (13–17.7) | 16.7 (14.4–19)** |
| VE (L/min) | 53.4 (45.4–61.4) | 62.6 (53.8–71.4)* | 59.1 (48.5–69.8) | 69.5 (59.7–79.3)** | 53 (47.7–58.3) | 57.1 (49.4–64.8) | 57.3 (50.5–64.1) | 61.7 (54.7–68.7)* |
| RER | 1.05 (1–1.1) | 1.06 (1.03–1.1) | 1.05 (0.988–1.12) | 1.08 (1.01–1.14) | 1.04 (0.958–1.13) | 1.06 (0.983–1.13) | 1.1 (1.07–1.13) | 1.11 (1.03–1.18) |
| HRrest (b.p.m) | 76.7 (70.5–83) | 72.6 (68.6–76.6) | 70.4 (65.1–75.7) | 66.4 (62.9–69.8) | 72.8 (68.5–77) | 70 (67–73)* | 64.8 (57–72.6) | 65.8 (57.5–74.2) |
| HRpeak (b.p.m) | 130 (117.6–142.4) | 135.2 (125.4–144.9) | 123.4 (113.5–133.4) | 123 (113–133.1) | 126.2 (115.5–137) | 130.4 (121.7–139) | 135.5 (126.4–144.6) | 134.8 (125.3–144.4) |
| SBPrest (mmHg) | 111.3 (103.9–118.7) | 108.3 (99.94–116.6) | 108.4 (100.4–116.3) | 108.2 (101.7–114.8) | 113.6 (106.3–120.9) | 109 (102.7–115.3) | 113.1 (105.4–120.8) | 108.6 (102.1–115.1) |
| SBPpeak (mmHg) | 152.8 (144.8–160.8) | 161.9 (152.4–171.4)*** | 151.5 (138.6–164.4) | 150.6 (138.9–162.4) | 144.7 (133.3–156.1) | 150.2 (140.9–159.6) | 150.3 (138.2–162.4) | 153.4 (142.7–164.1) |
| CP (mL/kg/min⋅mmHg) | 2650 (2306–2995) | 3282 (2890–3673)**** | 2568 (2169–2968) | 2799 (2409–3188) | 2543 (2181–2905) | 2828 (2511–3145)* | 2719 (2235–3203) | 2986 (2618–3355)* |
| Echocardiography parameters (primary endpoints: LVEDD, LVESD) | ||||||||
| LVEF (%) | 28.3 (25.9–30.7) | 29.9 (27.4–32.4)*** | 28.8 (25.1–32.5) | 31.6 (27.7–35.4)** | 29.6 (27.2–32.1) | 31.5 (28.9–34.1)** | 26.8 (24.7–28.8) | 29.1 (25.7–32.4)* |
| LVEDD (mm) | 65.3 (61.9–68.7) | 63.9 (60.6–67.2)** | 65.6 (61.4–69.9) | 63.8 (59.6–68.1)* | 64.4 (60.8–67.9) | 63 (59.9–66.1)** | 66.7 (64–69.5) | 65.6 (62.8–68.4)** |
| LVESD (mm) | 55.1 (50.8–59.3) | 52.5 (48.6–56.3)*** | 55.9 (51.5–60.3) | 54.4 (49.8–58.9)* | 54 (49.2–58.8) | 53.6 (48.7–58.5) | 59 (55.9–62.1) | 58.7 (55.8–61.5) |
| Secondary endpoints and other study outcomes | ||||||||
| PImax (cmH2O) | 82.6 (73.9–91.3) | 112 (102–122)**** | 85.6 (75.6–95.5) | 108 (99.7–117)**** | 79.8 (70.3–89.4) | 80.4 (71.2–89.5) | 83.1 (75.3–90.8) | 87 (78.4–95.6)** |
| SPImax (cmH2O s−1⋅10−3) | 308.2 (296.5–319.9) | 412.9 (401.3–424.5)**** | 303.6 (291.8–315.4) | 413.6 (396.3–430.9)**** | 315.3 (296.6–334) | 310.9 (295.3–326.5) | 313.3 (297.8–328.9) | 312.8 (295.2–330.3) |
| QMS (kg) | 23.5 (20.2–26.7) | 29.8 (26.2–33.3)**** | 21.3 (18.5–24.1) | 21.6 (18.7–24.5) | 23.2 (19.6–26.8) | 30.1 (26.2–34.1)**** | 22.1 (18.7–25.5) | 21.9 (18.8–25) |
| QME (kg⋅max reps) | 151.6 (128.9–174.3) | 207 (178.4–235.7)**** | 149 (124.4–173.7) | 153.8 (127.7–180) | 147.9 (123.1–172.6) | 216.6 (186.3–246.9)**** | 144.4 (124.8–164) | 152.8 (134.2–171.4)* |
| 6 min walk test (m) | 470.4 (438.8–501.9) | 542.6 (509.1–576.1)**** | 424.6 (397.5–451.6) | 452.2 (416.2–488.2)* | 478.7 (444.4–513.1) | 553.1 (518.7–587.5)**** | 437.7 (403.9–471.4) | 455.5 (413.1–497.9)* |
| Dyspnoea6mwt (Borg. 0–10) | 3.8 (3.2–4.5) | 2.9 (2.5–3.3)**** | 4.2 (3.5–4.8) | 2.4 (2.1–2.8)**** | 3.2 (2.6–3.8) | 2.5 (1.8–3.1)** | 4.1 (3.4–4.7) | 4.2 (3.6–4.9) |
| DyspnoeaCPX (Borg. 0–10) | 8.4 (8.2–8.7) | 7.7 (7.4–8)*** | 8.5 (8.3–8.7) | 8 (7.6–8.3)** | 8.4 (8.1–8.6) | 8.6 (8.3–8.9) | 8.2 (7.9–8.5) | 8.3 (7.9–8.6) |
| NYHA | 2.5 (2.3–2.8) | 1.9 (1.6–2.2)**** | 2.4 (2.1–2.6) | 2 (1.7–2.2)* | 2.3 (2.1–2.5) | 2.1 (1.8–2.3)* | 2.4 (2.1–2.6) | 2.1 (1.7–2.5)* |
| MLwHFQ | 40.9 (37.3–44.6) | 31.4 (27.9–34.9)**** | 41 (37.1–44.9) | 32.2 (28.8–35.7)**** | 41.3 (37.6–45) | 39.5 (35.2–43.8)* | 41.6 (38.3–44.9) | 40.9 (37.6–44.2) |
| PPS (1–5) | 4.8 (4.7–5.0)§ | 4.6 (4.3–4.8) | 4.5 (4.1–4.8) | 4.4 (4.2–4.7) | ||||
Pre-specified endpoints in bold.
CP, circulatory power; HR, heart rate; LVEDD, left ventricular end-diastolic diameter; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic diameter; MLwHFQ, Minnesota Living with Heart Failure Questionnaire; NYHA, New York Heart Association; peakVO2, peak oxygen consumption; PImax, maximal inspiratory pressure; PPS, programme preference survey; QME, quadriceps muscle endurance; QMS, quadriceps muscle strength; RER, respiratory exchange ration; SBP, systolic blood pressure; SPImax, sustained maximal inspiratory pressure; VT, ventilatory threshold.
*P ≤ 0.05; **P ≤ 0.01; ***P ≤ 0.001; ****P ≤ 0.0001 P-values derived using paired Student’s t-test after checking for the normality of the distributions for within group differences.
P ≤ 0.05 P-value derived using Wilcoxon test after Hommel correction for multiple comparisons.
| . | ARIS group (n = 19) . | AT/IMT group (n = 20) . | AT/RT group (n = 17) . | AT group (n = 18) . | ||||
|---|---|---|---|---|---|---|---|---|
| CPX parameters (primary endpoint: peakVO2) . | ||||||||
| Baseline . | 12 weeks . | Baseline . | 12 weeks . | Baseline . | 12 weeks . | Baseline . | 12 weeks . | |
| peakVO2 (mL/kg/min) | 17.4 (15.2–19.5) | 20.4 (18.3–22.6)**** | 16.6 (15–18.3) | 18.3 (16.6–20)** | 17.4 (15.6–19.3) | 18.8 (17.1–20.5)* | 18 (15.9–20) | 19.5 (17.4–21.7)* |
| Exercise time (min) | 9.0/9 (7.89–10.3) | 11.1 (9.94–12.2)**** | 8.08 (6.76–9.4) | 9.58 (8.43–10.7)*** | 8.19 (6.86–9.52) | 9.46 (8.46–10.4)** | 8.9 (8.29–9.5) | 9.39 (8.66–10.1) |
| VE/CO2 slope | 37.5 (34–41.1) | 35.2 (32.5–37.8)* | 34.6 (31.7–37.5) | 34.8 (31.6–38) | 36.3 (32.1–40.4) | 33.4 (30.4–36.4) | 34.2 (31.5–36.9) | 33.8 (31.1–36.4) |
| VT (mL/kg/min) | 15.4 (13.4–17.5) | 17.4 (15–19.8)** | 14 (12.5–15.5) | 15.2 (13.4–17) | 16 (14.2–17.8) | 16.6 (14.8–18.4) | 15.3 (13–17.7) | 16.7 (14.4–19)** |
| VE (L/min) | 53.4 (45.4–61.4) | 62.6 (53.8–71.4)* | 59.1 (48.5–69.8) | 69.5 (59.7–79.3)** | 53 (47.7–58.3) | 57.1 (49.4–64.8) | 57.3 (50.5–64.1) | 61.7 (54.7–68.7)* |
| RER | 1.05 (1–1.1) | 1.06 (1.03–1.1) | 1.05 (0.988–1.12) | 1.08 (1.01–1.14) | 1.04 (0.958–1.13) | 1.06 (0.983–1.13) | 1.1 (1.07–1.13) | 1.11 (1.03–1.18) |
| HRrest (b.p.m) | 76.7 (70.5–83) | 72.6 (68.6–76.6) | 70.4 (65.1–75.7) | 66.4 (62.9–69.8) | 72.8 (68.5–77) | 70 (67–73)* | 64.8 (57–72.6) | 65.8 (57.5–74.2) |
| HRpeak (b.p.m) | 130 (117.6–142.4) | 135.2 (125.4–144.9) | 123.4 (113.5–133.4) | 123 (113–133.1) | 126.2 (115.5–137) | 130.4 (121.7–139) | 135.5 (126.4–144.6) | 134.8 (125.3–144.4) |
| SBPrest (mmHg) | 111.3 (103.9–118.7) | 108.3 (99.94–116.6) | 108.4 (100.4–116.3) | 108.2 (101.7–114.8) | 113.6 (106.3–120.9) | 109 (102.7–115.3) | 113.1 (105.4–120.8) | 108.6 (102.1–115.1) |
| SBPpeak (mmHg) | 152.8 (144.8–160.8) | 161.9 (152.4–171.4)*** | 151.5 (138.6–164.4) | 150.6 (138.9–162.4) | 144.7 (133.3–156.1) | 150.2 (140.9–159.6) | 150.3 (138.2–162.4) | 153.4 (142.7–164.1) |
| CP (mL/kg/min⋅mmHg) | 2650 (2306–2995) | 3282 (2890–3673)**** | 2568 (2169–2968) | 2799 (2409–3188) | 2543 (2181–2905) | 2828 (2511–3145)* | 2719 (2235–3203) | 2986 (2618–3355)* |
| Echocardiography parameters (primary endpoints: LVEDD, LVESD) | ||||||||
| LVEF (%) | 28.3 (25.9–30.7) | 29.9 (27.4–32.4)*** | 28.8 (25.1–32.5) | 31.6 (27.7–35.4)** | 29.6 (27.2–32.1) | 31.5 (28.9–34.1)** | 26.8 (24.7–28.8) | 29.1 (25.7–32.4)* |
| LVEDD (mm) | 65.3 (61.9–68.7) | 63.9 (60.6–67.2)** | 65.6 (61.4–69.9) | 63.8 (59.6–68.1)* | 64.4 (60.8–67.9) | 63 (59.9–66.1)** | 66.7 (64–69.5) | 65.6 (62.8–68.4)** |
| LVESD (mm) | 55.1 (50.8–59.3) | 52.5 (48.6–56.3)*** | 55.9 (51.5–60.3) | 54.4 (49.8–58.9)* | 54 (49.2–58.8) | 53.6 (48.7–58.5) | 59 (55.9–62.1) | 58.7 (55.8–61.5) |
| Secondary endpoints and other study outcomes | ||||||||
| PImax (cmH2O) | 82.6 (73.9–91.3) | 112 (102–122)**** | 85.6 (75.6–95.5) | 108 (99.7–117)**** | 79.8 (70.3–89.4) | 80.4 (71.2–89.5) | 83.1 (75.3–90.8) | 87 (78.4–95.6)** |
| SPImax (cmH2O s−1⋅10−3) | 308.2 (296.5–319.9) | 412.9 (401.3–424.5)**** | 303.6 (291.8–315.4) | 413.6 (396.3–430.9)**** | 315.3 (296.6–334) | 310.9 (295.3–326.5) | 313.3 (297.8–328.9) | 312.8 (295.2–330.3) |
| QMS (kg) | 23.5 (20.2–26.7) | 29.8 (26.2–33.3)**** | 21.3 (18.5–24.1) | 21.6 (18.7–24.5) | 23.2 (19.6–26.8) | 30.1 (26.2–34.1)**** | 22.1 (18.7–25.5) | 21.9 (18.8–25) |
| QME (kg⋅max reps) | 151.6 (128.9–174.3) | 207 (178.4–235.7)**** | 149 (124.4–173.7) | 153.8 (127.7–180) | 147.9 (123.1–172.6) | 216.6 (186.3–246.9)**** | 144.4 (124.8–164) | 152.8 (134.2–171.4)* |
| 6 min walk test (m) | 470.4 (438.8–501.9) | 542.6 (509.1–576.1)**** | 424.6 (397.5–451.6) | 452.2 (416.2–488.2)* | 478.7 (444.4–513.1) | 553.1 (518.7–587.5)**** | 437.7 (403.9–471.4) | 455.5 (413.1–497.9)* |
| Dyspnoea6mwt (Borg. 0–10) | 3.8 (3.2–4.5) | 2.9 (2.5–3.3)**** | 4.2 (3.5–4.8) | 2.4 (2.1–2.8)**** | 3.2 (2.6–3.8) | 2.5 (1.8–3.1)** | 4.1 (3.4–4.7) | 4.2 (3.6–4.9) |
| DyspnoeaCPX (Borg. 0–10) | 8.4 (8.2–8.7) | 7.7 (7.4–8)*** | 8.5 (8.3–8.7) | 8 (7.6–8.3)** | 8.4 (8.1–8.6) | 8.6 (8.3–8.9) | 8.2 (7.9–8.5) | 8.3 (7.9–8.6) |
| NYHA | 2.5 (2.3–2.8) | 1.9 (1.6–2.2)**** | 2.4 (2.1–2.6) | 2 (1.7–2.2)* | 2.3 (2.1–2.5) | 2.1 (1.8–2.3)* | 2.4 (2.1–2.6) | 2.1 (1.7–2.5)* |
| MLwHFQ | 40.9 (37.3–44.6) | 31.4 (27.9–34.9)**** | 41 (37.1–44.9) | 32.2 (28.8–35.7)**** | 41.3 (37.6–45) | 39.5 (35.2–43.8)* | 41.6 (38.3–44.9) | 40.9 (37.6–44.2) |
| PPS (1–5) | 4.8 (4.7–5.0)§ | 4.6 (4.3–4.8) | 4.5 (4.1–4.8) | 4.4 (4.2–4.7) | ||||
| . | ARIS group (n = 19) . | AT/IMT group (n = 20) . | AT/RT group (n = 17) . | AT group (n = 18) . | ||||
|---|---|---|---|---|---|---|---|---|
| CPX parameters (primary endpoint: peakVO2) . | ||||||||
| Baseline . | 12 weeks . | Baseline . | 12 weeks . | Baseline . | 12 weeks . | Baseline . | 12 weeks . | |
| peakVO2 (mL/kg/min) | 17.4 (15.2–19.5) | 20.4 (18.3–22.6)**** | 16.6 (15–18.3) | 18.3 (16.6–20)** | 17.4 (15.6–19.3) | 18.8 (17.1–20.5)* | 18 (15.9–20) | 19.5 (17.4–21.7)* |
| Exercise time (min) | 9.0/9 (7.89–10.3) | 11.1 (9.94–12.2)**** | 8.08 (6.76–9.4) | 9.58 (8.43–10.7)*** | 8.19 (6.86–9.52) | 9.46 (8.46–10.4)** | 8.9 (8.29–9.5) | 9.39 (8.66–10.1) |
| VE/CO2 slope | 37.5 (34–41.1) | 35.2 (32.5–37.8)* | 34.6 (31.7–37.5) | 34.8 (31.6–38) | 36.3 (32.1–40.4) | 33.4 (30.4–36.4) | 34.2 (31.5–36.9) | 33.8 (31.1–36.4) |
| VT (mL/kg/min) | 15.4 (13.4–17.5) | 17.4 (15–19.8)** | 14 (12.5–15.5) | 15.2 (13.4–17) | 16 (14.2–17.8) | 16.6 (14.8–18.4) | 15.3 (13–17.7) | 16.7 (14.4–19)** |
| VE (L/min) | 53.4 (45.4–61.4) | 62.6 (53.8–71.4)* | 59.1 (48.5–69.8) | 69.5 (59.7–79.3)** | 53 (47.7–58.3) | 57.1 (49.4–64.8) | 57.3 (50.5–64.1) | 61.7 (54.7–68.7)* |
| RER | 1.05 (1–1.1) | 1.06 (1.03–1.1) | 1.05 (0.988–1.12) | 1.08 (1.01–1.14) | 1.04 (0.958–1.13) | 1.06 (0.983–1.13) | 1.1 (1.07–1.13) | 1.11 (1.03–1.18) |
| HRrest (b.p.m) | 76.7 (70.5–83) | 72.6 (68.6–76.6) | 70.4 (65.1–75.7) | 66.4 (62.9–69.8) | 72.8 (68.5–77) | 70 (67–73)* | 64.8 (57–72.6) | 65.8 (57.5–74.2) |
| HRpeak (b.p.m) | 130 (117.6–142.4) | 135.2 (125.4–144.9) | 123.4 (113.5–133.4) | 123 (113–133.1) | 126.2 (115.5–137) | 130.4 (121.7–139) | 135.5 (126.4–144.6) | 134.8 (125.3–144.4) |
| SBPrest (mmHg) | 111.3 (103.9–118.7) | 108.3 (99.94–116.6) | 108.4 (100.4–116.3) | 108.2 (101.7–114.8) | 113.6 (106.3–120.9) | 109 (102.7–115.3) | 113.1 (105.4–120.8) | 108.6 (102.1–115.1) |
| SBPpeak (mmHg) | 152.8 (144.8–160.8) | 161.9 (152.4–171.4)*** | 151.5 (138.6–164.4) | 150.6 (138.9–162.4) | 144.7 (133.3–156.1) | 150.2 (140.9–159.6) | 150.3 (138.2–162.4) | 153.4 (142.7–164.1) |
| CP (mL/kg/min⋅mmHg) | 2650 (2306–2995) | 3282 (2890–3673)**** | 2568 (2169–2968) | 2799 (2409–3188) | 2543 (2181–2905) | 2828 (2511–3145)* | 2719 (2235–3203) | 2986 (2618–3355)* |
| Echocardiography parameters (primary endpoints: LVEDD, LVESD) | ||||||||
| LVEF (%) | 28.3 (25.9–30.7) | 29.9 (27.4–32.4)*** | 28.8 (25.1–32.5) | 31.6 (27.7–35.4)** | 29.6 (27.2–32.1) | 31.5 (28.9–34.1)** | 26.8 (24.7–28.8) | 29.1 (25.7–32.4)* |
| LVEDD (mm) | 65.3 (61.9–68.7) | 63.9 (60.6–67.2)** | 65.6 (61.4–69.9) | 63.8 (59.6–68.1)* | 64.4 (60.8–67.9) | 63 (59.9–66.1)** | 66.7 (64–69.5) | 65.6 (62.8–68.4)** |
| LVESD (mm) | 55.1 (50.8–59.3) | 52.5 (48.6–56.3)*** | 55.9 (51.5–60.3) | 54.4 (49.8–58.9)* | 54 (49.2–58.8) | 53.6 (48.7–58.5) | 59 (55.9–62.1) | 58.7 (55.8–61.5) |
| Secondary endpoints and other study outcomes | ||||||||
| PImax (cmH2O) | 82.6 (73.9–91.3) | 112 (102–122)**** | 85.6 (75.6–95.5) | 108 (99.7–117)**** | 79.8 (70.3–89.4) | 80.4 (71.2–89.5) | 83.1 (75.3–90.8) | 87 (78.4–95.6)** |
| SPImax (cmH2O s−1⋅10−3) | 308.2 (296.5–319.9) | 412.9 (401.3–424.5)**** | 303.6 (291.8–315.4) | 413.6 (396.3–430.9)**** | 315.3 (296.6–334) | 310.9 (295.3–326.5) | 313.3 (297.8–328.9) | 312.8 (295.2–330.3) |
| QMS (kg) | 23.5 (20.2–26.7) | 29.8 (26.2–33.3)**** | 21.3 (18.5–24.1) | 21.6 (18.7–24.5) | 23.2 (19.6–26.8) | 30.1 (26.2–34.1)**** | 22.1 (18.7–25.5) | 21.9 (18.8–25) |
| QME (kg⋅max reps) | 151.6 (128.9–174.3) | 207 (178.4–235.7)**** | 149 (124.4–173.7) | 153.8 (127.7–180) | 147.9 (123.1–172.6) | 216.6 (186.3–246.9)**** | 144.4 (124.8–164) | 152.8 (134.2–171.4)* |
| 6 min walk test (m) | 470.4 (438.8–501.9) | 542.6 (509.1–576.1)**** | 424.6 (397.5–451.6) | 452.2 (416.2–488.2)* | 478.7 (444.4–513.1) | 553.1 (518.7–587.5)**** | 437.7 (403.9–471.4) | 455.5 (413.1–497.9)* |
| Dyspnoea6mwt (Borg. 0–10) | 3.8 (3.2–4.5) | 2.9 (2.5–3.3)**** | 4.2 (3.5–4.8) | 2.4 (2.1–2.8)**** | 3.2 (2.6–3.8) | 2.5 (1.8–3.1)** | 4.1 (3.4–4.7) | 4.2 (3.6–4.9) |
| DyspnoeaCPX (Borg. 0–10) | 8.4 (8.2–8.7) | 7.7 (7.4–8)*** | 8.5 (8.3–8.7) | 8 (7.6–8.3)** | 8.4 (8.1–8.6) | 8.6 (8.3–8.9) | 8.2 (7.9–8.5) | 8.3 (7.9–8.6) |
| NYHA | 2.5 (2.3–2.8) | 1.9 (1.6–2.2)**** | 2.4 (2.1–2.6) | 2 (1.7–2.2)* | 2.3 (2.1–2.5) | 2.1 (1.8–2.3)* | 2.4 (2.1–2.6) | 2.1 (1.7–2.5)* |
| MLwHFQ | 40.9 (37.3–44.6) | 31.4 (27.9–34.9)**** | 41 (37.1–44.9) | 32.2 (28.8–35.7)**** | 41.3 (37.6–45) | 39.5 (35.2–43.8)* | 41.6 (38.3–44.9) | 40.9 (37.6–44.2) |
| PPS (1–5) | 4.8 (4.7–5.0)§ | 4.6 (4.3–4.8) | 4.5 (4.1–4.8) | 4.4 (4.2–4.7) | ||||
Pre-specified endpoints in bold.
CP, circulatory power; HR, heart rate; LVEDD, left ventricular end-diastolic diameter; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic diameter; MLwHFQ, Minnesota Living with Heart Failure Questionnaire; NYHA, New York Heart Association; peakVO2, peak oxygen consumption; PImax, maximal inspiratory pressure; PPS, programme preference survey; QME, quadriceps muscle endurance; QMS, quadriceps muscle strength; RER, respiratory exchange ration; SBP, systolic blood pressure; SPImax, sustained maximal inspiratory pressure; VT, ventilatory threshold.
*P ≤ 0.05; **P ≤ 0.01; ***P ≤ 0.001; ****P ≤ 0.0001 P-values derived using paired Student’s t-test after checking for the normality of the distributions for within group differences.
P ≤ 0.05 P-value derived using Wilcoxon test after Hommel correction for multiple comparisons.
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
