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Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO): a pilot randomised controlled trial
  1. Swapna Mandal1,2,
  2. Eui-Sik Suh1,2,
  3. Rachel Harding1,
  4. Anna Vaughan-France1,
  5. Michelle Ramsay1,2,
  6. Bronwen Connolly1,
  7. Danielle E Bear1,
  8. Helen MacLaughlin3,
  9. Sharlene A Greenwood4,
  10. Michael I Polkey5,
  11. Mark Elliott6,
  12. Tao Chen7,
  13. Abdel Douiri7,
  14. John Moxham2,3,
  15. Patrick B Murphy1,2,
  16. Nicholas Hart1,2,8
  1. 1Lane-Fox Respiratory Service, Guy’s and St Thomas NHS Foundation Trust, St Thomas’ Hospital, London, UK
  2. 2Division of Asthma Allergy and Lung Biology, King’s College London School of Medical Education, London, UK
  3. 3King’s College Hospital, London, UK
  4. 4Department of Renal Medicine, King’s College London, London, UK
  5. 5NIHR Respiratory BRU, Royal Brompton Hospital and National Heart and Lung Institute, London, UK
  6. 6St James’ Hospital, Leeds, UK
  7. 7Department of Primary Care and Public Health Sciences, King’s College London, London, UK
  8. 8NIHR Biomedical Research Centre, King’s College London, London, UK
  1. Correspondence to Dr Swapna Mandal, Lane-Fox Respiratory Unit, St Thomas’ Hospital, London SE1 7EH, UK; swapnamandal{at}nhs.net

Abstract

Background Respiratory management of obesity hypoventilation syndrome (OHS) focusses on the control of sleep-disordered breathing rather than the treatment of obesity. Currently, there are no data from randomised trials of weight loss targeted rehabilitation programmes for patients with OHS.

Intervention A 3-month multimodal hybrid inpatient–outpatient motivation, exercise and nutrition rehabilitation programme, in addition to non invasive ventilation (NIV), would result in greater per cent weight loss compared with standard care.

Methods A single-centre pilot randomised controlled trial allocated patients to either standard care or standard care plus rehabilitation. Primary outcome was per cent weight loss at 12 months with secondary exploratory outcomes of weight loss, exercise capacity and health-related quality of life (HRQOL) at the end of the rehabilitation programme to assess the intervention effect.

Results Thirty-seven patients (11 male, 59.8±12.7 years) with a body mass index of 51.1±7.7 kg/m2 were randomised. At 12 months, there was no between-group difference in per cent weight loss (mean difference −5.9% (95% CI −14.4% to 2.7%; p=0.17)). At 3 months, there was a greater per cent weight loss (mean difference −5% (95% CI −8.3% to −1.4%; p=0.007)), increased exercise capacity (6 min walk test 60 m (95% CI 29.5 to 214.5) vs 20 m (95% CI 11.5 to 81.3); p=0.036) and HRQL (mean difference SF-36 general health score (10 (95% CI 5 to 21.3) vs 0 (95% CI −5 to 10); p=0.02)) in the rehabilitation group.

Conclusion In patients with OHS, a 3-month comprehensive rehabilitation programme, in addition to NIV, resulted in improved weight loss, exercise capacity and QOL at the end of the rehabilitation period, but these effects were not demonstrated at 12 months, in part, due to the limited retention of patients at 12 months.

Trial registration number Pre-results; NCT01483716.

  • non invasive ventilation
  • pulmonary rehabilitation

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Footnotes

  • Contributors SM was responsible for data collection, analysis and manuscript preparation. ES, MR, BC, RH and AVF assisted with data collection and contributed to manuscript preparation. AD and TC assisted with data analysis and manuscript preparation. NH, MIP, JM, PBM, ME, DEB, HM and SAG were all involved with manuscript preparation.

  • Funding This trial was funded by the Guy’s and St Thomas’ Charity. The Lane Fox Respiratory Service, Guy’s and St Thomas’ NHS Trust and King’s College London acknowledge the support of the National Institute for Health Research, through the Clinical Research Network. AD acknowledges financial support from the National Institutefor Health Research Biomedical Research Centre at Guy’s and St Thomas’ National Health Service (NHS) Foundation Trust and King’s College London and support from the NIHR Collaboration for Leadership in Applied Health Research and Care South London (CLAHRC South London).

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests ME reports personal fees from Resmed, personal fees from Phillips Respironics, MIP reports personal fees from Philips Respironics, DEB reports personal fees from Nutricia, Baxter, Fresenius Kabi and Braun, PBM reports grants and personal fees from Philips-Respironics, grants from Resmed, grants from B&D electro medical NH reports grants and personal fees from Philips and Philips-Respironics, Resmed, Fisher-Paykel, B&D Electromedical, personal fees from Astra Zeneca; in addition, NH has a patent pending for Myotrace. Other authors have no competing interest to declare.

  • Ethics approval The study was approved by Westminster National Research Ethics Committee (11/LO/48) and prospectivelyregistered on clinicaltrials.gov (NCT01483716) and by the National Institutefor Health Research UK Clinical Research Network (UKCRN 11778).

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

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