OBJECTIVE:Newer generation left ventricular assist devices (LVADs) are established for long-term support. The aim of this multi-modal intervention was to improve the body weight, exercise tolerance and psychosocial status in outpatients on long-term LVAD support. METHODS:Seventy patients participated in this non-randomized intervention study [intervention group (IGr) n = 34; control group (CGr) n = 36] over 18 months (T1-T4); the baseline sample characteristics showed no differences between groups. Dietary counselling and weight management intervention was performed by a dietician based on a specific algorithm. Physical reconditioning followed a home ergometry protocol and was supplemented by psychosocial counselling. The outcomes were measured based on the body mass index (BMI), cardiopulmonary exercise testing and self-report [hospital anxiety and depression scale (HADS), SF-36]. RESULTS: The intervention showed a strong positive effect on nutrition and weight management [95% confidence interval (CI): -0.71-0.69; effect size (ES): 0.907; P = 0.02)], resulting in the normal BMI (kg/m(2)) values in the IGr (T1: 24.0 ± 0.6; T4: 24.5 ± 1.1; P = 0.35) compared with a significant BMI increase in the CGr (T1: 23.8 ± 0.6; T4: 29.7 ± 0.8; P = 0.05). Significant differences appeared regarding exercise tolerance (VO(2)max/% predicted) in favour of IGr patients (IGr: 69 ± 2.9; CGr 62 ± 3.7; P = 0.04). This increase was reflected by patients' self-reporting based on the SF-36 physical component score (IGr: P = 0.04; CGr: P = 0.54). SF-36psychosocial component scores showed no changes for both groups. However, CGr showed a tendency for increased anxiety scores relative to their counterparts (IGr: 4.95 ± 0.4; CGr: 6.6 ± 0.9; P = 0.03). CONCLUSIONS: IGr patients showed a strong benefit from a multi-modal intervention, including dietary counselling, controlled exercise and psychosocial support. Dietary counselling holds potential to prevent obesity in this patient population.
RCT Entities:
OBJECTIVE: Newer generation left ventricular assist devices (LVADs) are established for long-term support. The aim of this multi-modal intervention was to improve the body weight, exercise tolerance and psychosocial status in outpatients on long-term LVAD support. METHODS: Seventy patients participated in this non-randomized intervention study [intervention group (IGr) n = 34; control group (CGr) n = 36] over 18 months (T1-T4); the baseline sample characteristics showed no differences between groups. Dietary counselling and weight management intervention was performed by a dietician based on a specific algorithm. Physical reconditioning followed a home ergometry protocol and was supplemented by psychosocial counselling. The outcomes were measured based on the body mass index (BMI), cardiopulmonary exercise testing and self-report [hospital anxiety and depression scale (HADS), SF-36]. RESULTS: The intervention showed a strong positive effect on nutrition and weight management [95% confidence interval (CI): -0.71-0.69; effect size (ES): 0.907; P = 0.02)], resulting in the normal BMI (kg/m(2)) values in the IGr (T1: 24.0 ± 0.6; T4: 24.5 ± 1.1; P = 0.35) compared with a significant BMI increase in the CGr (T1: 23.8 ± 0.6; T4: 29.7 ± 0.8; P = 0.05). Significant differences appeared regarding exercise tolerance (VO(2)max/% predicted) in favour of IGr patients (IGr: 69 ± 2.9; CGr 62 ± 3.7; P = 0.04). This increase was reflected by patients' self-reporting based on the SF-36 physical component score (IGr: P = 0.04; CGr: P = 0.54). SF-36 psychosocial component scores showed no changes for both groups. However, CGr showed a tendency for increased anxiety scores relative to their counterparts (IGr: 4.95 ± 0.4; CGr: 6.6 ± 0.9; P = 0.03). CONCLUSIONS: IGr patients showed a strong benefit from a multi-modal intervention, including dietary counselling, controlled exercise and psychosocial support. Dietary counselling holds potential to prevent obesity in this patient population.
Authors: Richard Severin; Ahmad Sabbahi; Cemal Ozemek; Shane Phillips; Ross Arena Journal: Expert Rev Med Devices Date: 2019-09-06 Impact factor: 3.166