Efficacy and Costs of Nutritional Rehabilitation in Muscle-Wasted Patients With Chronic Obstructive Pulmonary Disease in a Community-Based Setting: A Prespecified Subgroup Analysis of the INTERCOM Trial

RATIONALE: Limited data are available on effectiveness and costs of nutritional rehabilitation for patients with COPD in community care. METHODS: In a 2-year RCT, 199 COPD patients (FEV(1)%pred. 60% [SD 16%]) and impaired exercise capacity were randomized to the interdisciplinary community-based COPD management program (INTERCOM) or usual care (UC). A prescheduled subgroup analysis was performed on 39 of 199 patients who were muscle wasted and received UC or nutritional therapy in combination with exercise training. Body composition, muscle strength, and exercise capacity were assessed at baseline and 4, 12, and 24 months. RESULTS: Between group differences after 4 months in favor of the intervention group: fat free mass index (FFMI 0.9 kg/m(2) [SE = 0.2, P < .001]), body mass index (BMI 1.0 kg/m(2) [SE = 0.4, P = .009]), maximum inspiratory mouth pressure (Pimax 1.4 kPa [SE = 0.5, P = .011]), quadriceps average power (QAP 13.1 Watt [SE=5.8, P = .036]), 6-minute walking distance (6MWD 27 m, [SE = 11.5, P = .028]), cycle endurance time (CET 525 seconds [SE=195, P = .013]), and peak exercise capacity (Wmax 12 Watt [SE = 5, P = .036]). Between group difference over 24 months in favor of the intervention group: Pimax 1.7 kPa (SE = 0.53, P = .004), QAP 19 Watt (SE = 6, P = .005), 6MWD 57 (SE = 19, P = .006), and CET 485 seconds (SE = 159, P = .006). After 4 months total costs were Euro 1501 higher in the intervention group than in the UC group (P < .05), but not significantly different after 24 months. Hospital admission costs were significantly lower in the intervention group -euro 4724 (95% CI -7704, -1734). CONCLUSION: This study in muscle-wasted COPD patients with moderate airflow obstruction shows a prolonged positive response to nutritional support integrated in a community-based rehabilitation program. Clinical trial.gov: NCT00840892.