title: Multimodal nutritional rehabilitation improves clinical outcomes of malnourished patients with chronic respiratory failure: a randomised controlled trial.
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.
authors.affiliation: Clinique de Pneumologie, CHU Grenoble, F-38000 Grenoble, France. cpison@chu-grenoble.fr
authors.forename: Christophe M
authors.initials: CM
authors.lastname: Pison
authors.forename: Noël J
authors.initials: NJ
authors.lastname: Cano
authors.forename: Cécile
authors.initials: C
authors.lastname: Chérion
authors.forename: Fabrice
authors.initials: F
authors.lastname: Caron
authors.forename: Isabelle
authors.initials: I
authors.lastname: Court-Fortune
authors.forename: Marie-Thérèse
authors.initials: MT
authors.lastname: Antonini
authors.forename: Jésus
authors.initials: J
authors.lastname: Gonzalez-Bermejo
authors.forename: Lahouari
authors.initials: L
authors.lastname: Meziane
authors.forename: Luis Carlos
authors.initials: LC
authors.lastname: Molano
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Janssens
authors.forename: Frédéric
authors.initials: F
authors.lastname: Costes
authors.forename: Bernard
authors.initials: B
authors.lastname: Wuyam
authors.forename: Thomas
authors.initials: T
authors.lastname: Similowski
authors.forename: Boris
authors.initials: B
authors.lastname: Melloni
authors.forename: Maurice
authors.initials: M
authors.lastname: Hayot
authors.forename: Julie
authors.initials: J
authors.lastname: Augustin
authors.forename: Catherine
authors.initials: C
authors.lastname: Tardif
authors.forename: Hervé
authors.initials: H
authors.lastname: Lejeune
authors.forename: Hubert
authors.initials: H
authors.lastname: Roth
authors.forename: Claude
authors.initials: C
authors.lastname: Pichard
mesh_terms: D000368:Aged; D001823:Body Composition; D002908:Chronic Disease; D003131:Combined Modality Therapy; D019587:Dietary Supplements; D005081:Exercise Therapy; D017079:Exercise Tolerance / Q000502:physiology; D005260:Female; D006266:Health Education / Q000379:methods; D018575:Home Care Services, Hospital-Based; D006801:Humans; D008297:Male; D044342:Malnutrition / Q000209:etiology / Q000503:physiopathology / Q000534:rehabilitation*; D008875:Middle Aged; D009752:Nutritional Status; D011788:Quality of Life; D012131:Respiratory Insufficiency / Q000150:complications / Q000503:physiopathology / Q000534:rehabilitation*; D013739:Testosterone / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D013739:Testosterone