Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO): a pilot randomised controlled trial

Swapna Mandal; Eui Sik Suh; Rachel Harding; Anna Vaughan-France; Michelle Ramsay; Bronwen Connolly; Danielle E. Bear; Helen MacLaughlin; Sharlene A. Greenwood; Michael I. Polkey; Mark Elliott; Tao Chen; Abdel Douiri; John Moxham; Patrick B. Murphy; Nicholas Hart

doi:10.1136/thoraxjnl-2016-209826

Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO): a pilot randomised controlled trial

Swapna Mandal, Eui Sik Suh, Rachel Harding, Anna Vaughan-France, Michelle Ramsay, Bronwen Connolly, Danielle E. Bear, Helen MacLaughlin, Sharlene A. Greenwood, Michael I. Polkey, Mark Elliott, Tao Chen, Abdel Douiri, John Moxham, Patrick B. Murphy, Nicholas Hart

Population Health Sciences

Research output: Contribution to journal › Article › peer-review

37 Citations (Scopus)

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.

Original language	English
Pages (from-to)	62-69
Number of pages	8
Journal	Thorax
Volume	73
Issue number	1
Early online date	13 Dec 2017
DOIs	https://doi.org/10.1136/thoraxjnl-2016-209826
Publication status	Published - 1 Jan 2018

Keywords

non invasive ventilation
pulmonary rehabilitation

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/thoraxjnl-2016-209826

Cite this

Mandal, S., Suh, E. S., Harding, R., Vaughan-France, A., Ramsay, M., Connolly, B., Bear, D. E., MacLaughlin, H., Greenwood, S. A., Polkey, M. I., Elliott, M., Chen, T., Douiri, A., Moxham, J., Murphy, P. B., & Hart, N. (2018). Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO): a pilot randomised controlled trial. Thorax, 73(1), 62-69. https://doi.org/10.1136/thoraxjnl-2016-209826

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title = "Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO): a pilot randomised controlled trial",

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.",

keywords = "non invasive ventilation, pulmonary rehabilitation",

author = "Swapna Mandal and Suh, {Eui Sik} and Rachel Harding and Anna Vaughan-France and Michelle Ramsay and Bronwen Connolly and Bear, {Danielle E.} and Helen MacLaughlin and Greenwood, {Sharlene A.} and Polkey, {Michael I.} and Mark Elliott and Tao Chen and Abdel Douiri and John Moxham and Murphy, {Patrick B.} and Nicholas Hart",

year = "2018",

month = jan,

day = "1",

doi = "10.1136/thoraxjnl-2016-209826",

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number = "1",

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Mandal, S , Suh, ES, Harding, R, Vaughan-France, A, Ramsay, M, Connolly, B, Bear, DE, MacLaughlin, H, Greenwood, SA, Polkey, MI, Elliott, M, Chen, T , Douiri, A , Moxham, J , Murphy, PB & Hart, N 2018, 'Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO): a pilot randomised controlled trial', Thorax, vol. 73, no. 1, pp. 62-69. https://doi.org/10.1136/thoraxjnl-2016-209826

TY - JOUR

T1 - Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO)

T2 - a pilot randomised controlled trial

AU - Mandal, Swapna

AU - Suh, Eui Sik

AU - Harding, Rachel

AU - Vaughan-France, Anna

AU - Ramsay, Michelle

AU - Connolly, Bronwen

AU - Bear, Danielle E.

AU - MacLaughlin, Helen

AU - Greenwood, Sharlene A.

AU - Polkey, Michael I.

AU - Elliott, Mark

AU - Chen, Tao

AU - Douiri, Abdel

AU - Moxham, John

AU - Murphy, Patrick B.

AU - Hart, Nicholas

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - non invasive ventilation

KW - pulmonary rehabilitation

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U2 - 10.1136/thoraxjnl-2016-209826

DO - 10.1136/thoraxjnl-2016-209826

M3 - Article

C2 - 28971973

AN - SCOPUS:85039060284

SN - 0040-6376

VL - 73

SP - 62

EP - 69

JO - Thorax

JF - Thorax

IS - 1

ER -

Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO): a pilot randomised controlled trial

Abstract

Keywords

UN SDGs

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