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Multimodal nutritional rehabilitation improves clinical outcomes of malnourished patients with chronic respiratory failure: a randomised controlled trial
  1. Christophe M Pison1,2,3,
  2. Noël J Cano4,5,6,
  3. Cécile Chérion1,
  4. Fabrice Caron7,
  5. Isabelle Court-Fortune8,
  6. Marie-Thérèse Antonini9,
  7. Jésus Gonzalez-Bermejo10,11,
  8. Lahouari Meziane12,13,
  9. Luis Carlos Molano14,15,16,
  10. Jean-Paul Janssens17,18,
  11. Frédéric Costes19,20,
  12. Bernard Wuyam21,22,
  13. Thomas Similowski10,11,
  14. Boris Melloni23,
  15. Maurice Hayot12,13,
  16. Julie Augustin7,
  17. Catherine Tardif24,
  18. Hervé Lejeune25,26,
  19. Hubert Roth1,2,3,27,
  20. Claude Pichard18,28,
  21. the IRAD Investigators*
  1. 1Clinique de Pneumologie, CHU Grenoble, Grenoble, France
  2. 2Université Joseph Fourier, Grenoble, France
  3. 3Inserm U1055, Grenoble, France
  4. 4Clermont Université, Université d'Auvergne, Unité de Nutrition Humaine, Clermont-Ferrand, France
  5. 5INRA, UMR 1019, UNH, CRNH Auvergne, F-63000 Clermont-Ferrand, France
  6. 6Service de Nutrition, CHU Clermont-Ferrand, F-63000 Clermont-Ferrand, France
  7. 7Service de Pneumologie, CHU Poitiers, Hôpital de La Milétrie, Poitiers, France
  8. 8Service de Pneumologie, CHU Saint-Étienne, Saint-Etienne, France
  9. 9Explorations Fonctionnelles Physiologiques, CHU Limoges, Limoges, France
  10. 10Service de Réanimation et de Pneumologie, Groupe Pitié Salpetrière, Paris, France
  11. 11Université Paris 6, Paris, France
  12. 12Service de Physiologie Clinique, CHU Montpellier, Montpellier, France
  13. 13Inserm ERI25, Montpellier, France
  14. 14Service de Pneumologie et Soins Intensifs Respiratoires, CHU Rouen, Rouen, France
  15. 15EA3830 IFR MP23, Rouen, France
  16. 16Université Rouen, Rouen, France
  17. 17Pneumologie, Hôpitaux Universitaires de Genève, Genève, Switzerland
  18. 18Université Genève, Genève, Switzerland
  19. 19Service de Physiologie Clinique et de l'Exercice, Hôpital Nord, CHU Saint-Etienne, F-42000 Saint-Etienne, France
  20. 20Laboratoire Physiologie de l'Exercice, EA4338 Université Jean Monnet, Saint-Etienne, France
  21. 21Explorations Fonctionnelles Cardiorespiratoire, CHU Grenoble, Grenoble, France
  22. 22Inserm ERI0017, Grenoble, France
  23. 23Service de Pneumologie, CHU Limoges, Limoges, France
  24. 24Explorations Fonctionnelles Cardio-respiratoire, CHU Rouen, Rouen, France
  25. 25Médecine de la Reproduction, Hôpital Femme-Mère-Enfant, Bron, France
  26. 26Université Claude Bernard, Lyon, France
  27. 27CRNH Rhône-Alpes, Pierre-Bénite, France
  28. 28Nutrition Clinique, Hôpitaux Universitaires de Genève, CH-1201 Genève, Switzerland
  1. Correspondence to Christophe Pison, Clinique de Pneumologie, CHU Grenoble, F-38000 Grenoble, France; cpison{at}chu-grenoble.fr

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.

  • Chronic obstructive pulmonary disease
  • long-term oxygen therapy
  • nutrition
  • rehabilitation
  • quality of life
  • COPD pharmacology

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Footnotes

  • See Editorial, p 935

  • CMP and NJC contributed equally to this study.

  • * IRAD2 Investigators (1) Grenoble, France: CHU Michallon (C Pison, B Wuyam, E Maclet, I Vivodtzev, R Guzun), Inserm Grenoble Centre d'Investigation Clinique 03 (D Abry, N Henquin, JL Cracowski), AGIR à Dom (F Putod, JC Borel, AS Michallet); (2) Poitiers, France: CHU, Hôpital de La Milétrie (F Caron, JC Meurice, ML Adoun, J Augustin); (3) Saint-Etienne, France: CHU Nord (I. Court-Fortune, F Costes, B Januel, M Charles); (4) Limoges, France: CHU du Cluzeau-Dupuytren (B Melloni, MT Antonini, JC Desport, JM Ribardière, F Dalmay), ALAIR-AVD (P Samptiaux, V Arnold, P Dzugan, E Marchaisseau), Centre MGEN Ste Feyre (S Jeandeau, H Triki); (5) Montpellier, France: CHU Arnaud de Villeneuve (L Meziane, M Hayot, P Godard, C Préfaut); (6) Paris, France: CHU La Pitié Salpêtrière (J. Gonzalez-Bermejo, T Similowski, C Straus, E Dalmolin, E Cornu); (7) Rouen, France: CHU Bois Guillaume (LC Molano, C Tardif, A Cuvelier, JF Muir), ADIR (J Dupuis); (8) Genève, Switzerland: Hôpitaux Universitaires de Genève (C Pichard, JP Janssens). Centralised biological analysis centre: Lyon, France: Hôpital E Herriot (H Lejeune, C Lombard, B Claustrat, F Touraine).

  • Funding The study was investigator driven. Funds came from academic sources (Programme Hospitalier de Recherche Clinique National, Direction Interrégionale de la Recherche Clinique Rhône-Alpes Auvergne), public foundations (Nutrition 2000Plus), associations (Association Nationale pour les Traitements à Domicile, les Innovations et la Recherche-ANTADIR, AGIRàDom) and pharmaceutical sources (Nutricia Advanced Medical Nutrition, The Netherlands, France; Organon-Schering-Plough, Kenilworth, NJ, USA). The sponsors did not place any restrictions on the academic authors regarding the design and interpretation of the study, or statements made in the final manuscript.

  • Competing interests CP received financial support as research grants and consulting fees from Abbott, Baxter, B Braun, Cosmed, Fresenius-Kabi, Nestle, Novartis, Nutricia-Numico, Pfizer, Solvay; CMP and NJC from Nutricia Danone for honoraria and travel grants.

  • Patient consent Obtained.

  • Ethics approval This study was conducted with the approval of the Comité consultatif de protection des personnes se prêtant aux recherches biomédicales de Grenoble.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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