Multimodal nutritional rehabilitation improves clinical outcomes of malnourished patients with chronic respiratory failure: a randomised controlled trial

Thorax

Jun 2011

DOI: 10.1136/thx.2010.154922

Citations:100

Influential Citations:4

Interventional (Human) Studies

Enhanced Details

Methods

Prospective multicenter randomized controlled trial; 122 malnourished adults with chronic respiratory failure on long-term oxygen therapy and/or home ventilation; BMI ≤21 kg/m2 or FFMI <25th percentile; eight respiratory units; 60 randomized to multimodal rehabilitation and 62 to control; mean age ≈66 years; predominantly male (91 men, 31 women); intention-to-treat analysis; blinded assessment at day 90; per-protocol analyses for survival.

Intervention

90-day home-based multimodal rehabilitation comprising health education, oral nutritional supplements (ONS), and hormonal and exercise interventions delivered at home. ONS: three 120 mL servings daily (188 kcal per serving; 20% protein, 60% carbohydrate, 20% fat). Testosterone undecanoate given during fortnightly visits (80 mg twice daily in men; 40 mg twice daily in women) for 90 days. Exercise: endurance cycling 3–5 times per week starting at 50% of baseline peak workload with increments of 5 W, plus quadriceps strengthening. Seven home visits by nurses/physiotherapists with weekly follow-ups; ONS and hormones supplied during fortnightly visits and stopped on day 90; intervention period 0–90 days.

Results

At 3 months, BMI increased by 0.56 kg/m2 (95% CI 0.18 to 0.95; p=0.004), FFMI increased by 0.60 kg/m2 (95% CI 0.15 to 1.05; p=0.01), haemoglobin by 9.1 g/L (95% CI 2.5 to 15.7; p=0.008), peak workload by 7.2 W (95% CI 3.7 to 10.6; p<0.001), quadriceps isometric force by 28.3 N (95% CI 7.2 to 49.3; p=0.009), and endurance time by 5.9 min (95% CI 3.1 to 8.8; p<0.001). In women, quality of life (CRQ) improved by 16.5 units (95% CI 5.3 to 27.7; p=0.006). No significant change in 6-minute walk distance (6MWD). Exacerbation rate during 3 months was higher in rehabilitation (0.36 vs 0.14; p=0.045) but respiratory/non-respiratory hospitalisations did not differ. Among compliers, 15-month survival improved (HR 0.27; 95% CI 0.07 to 0.95; p=0.042) in per-protocol analysis; no significant survival difference in intention-to-treat analysis. Authors conclude multimodal nutritional rehabilitation improves body composition and related outcomes and may improve survival in compliant patients, supporting its incorporation in management of malnourished CRF.

Limitations

Survival benefit seen only in per-protocol analysis (potential compliance bias); no significant survival effect in intention-to-treat analysis; 3-month functional improvement did not include 6MWD; multiple components prevent isolation of individual contribution; limited sample size and generalizability; results require replication.

Abstract

Background In chronic respiratory failure (CRF), body composition strongly predicts survival. Methods A prospective randomised controlled trial was undertaken in malnourished patients with CRF to evaluate the effects of 3 months of home rehabilitation on body functioning and composition. 122 patients with CRF on long-term oxygen therapy and/or non-invasive ventilation (mean (SD) age 66 (10) years, 91 men) were included from eight respiratory units; 62 were assigned to home health education (controls) and 60 to multimodal nutritional rehabilitation combining health education, oral nutritional supplements, exercise and oral testosterone for 90 days. The primary endpoint was exercise tolerance assessed by the 6-min walking test (6MWT). Secondary endpoints were body composition, quality of life after 3 months and 15-month survival. Results Mean (SD) baseline arterial oxygen tension was 7.7 (1.2) kPa, forced expiratory volume in 1 s 31 (13)% predicted, body mass index (BMI) 21.5 (3.9) kg/m2 and fat-free mass index (FFMI) 15.5 (2.4) kg/m2. The intervention had no significant effect on 6MWT. Improvements (treatment effect) were seen in BMI (+0.56 kg/m2, 95% CI 0.18 to 0.95, p=0.004), FFMI (+0.60 kg/m2, 95% CI 0.15 to 1.05, p=0.01), haemoglobin (+9.1 g/l, 95% CI 2.5 to 15.7, p=0.008), peak workload (+7.2 W, 95% CI 3.7 to 10.6, p<0.001), quadriceps isometric force (+28.3 N, 95% CI 7.2 to 49.3, p=0.009), endurance time (+5.9 min, 95% CI 3.1 to 8.8, p<0.001) and, in women, Chronic Respiratory Questionnaire (+16.5 units, 95% CI 5.3 to 27.7, p=0.006). In a multivariate Cox analysis, only rehabilitation in a per-protocol analysis predicted survival (HR 0.27, 95% CI 0.07 to 0.95, p=0.042). Conclusions Multimodal nutritional rehabilitation aimed at improving body composition increased exercise tolerance, quality of life in women and survival in compliant patients, supporting its incorporation in the treatment of malnourished patients with CRF. Clinical Trial number NCT00230984. show less