Abstract
Approximately 670,000 people in the UK have dementia. Previous literature suggests physical exercise could slow dementia symptom progression.
Objectives
To estimate the clinical and cost-effectiveness of a bespoke exercise programme, in addition to usual care, on the cognitive impairment (primary outcome), function and health-related quality of life (HRQoL) of people with mild to moderate dementia (MMD), and carer burden and HRQoL.
Design
Intervention development, systematic review, multi-centred, RCT with parallel economic evaluation and qualitative study.
Setting
15 English regions
Participants
People with MMD living in the community.
Intervention
4-month moderate to high intensity, structured exercise programme designed specifically for people with MMD with support to continue unsupervised physical activity thereafter. Exercises were individually prescribed and progressed and participants were supervised in groups. The comparator was usual practice.
Main outcome measures
Alzheimer’s disease Assessment Scale – Cognitive Subscale (ADAS-Cog). Secondary outcomes were function (Bristol Activities of Daily Living Scale), generic HRQoL (EQ-5D-3L), dementia related QoL (QoL-AD), behavioural symptoms (Neuropsychiatric Inventory), physical fitness (6MWT) and muscle strength. Carer outcomes were EQ-5D-3L and carer burden (Zarit Burden Inventory). Economic evaluation was expressed in terms of incremental cost per quality-adjusted life year (QALY) gained from a NHS and Personal Social Services perspective. Participants were followed up for 12 months.
Results
Between February 2013 and June 2015, 494 participants were randomised with an intentional unequal allocation ratio: 165 to usual care, 329 the intervention. The mean age of participants was 77 (SD 7.9) years, 39% (193/494) were female and mean baseline ADAS-Cog score was 21.5 (SD 9.0). Participants in the intervention arm achieved high compliance rates with 65% (214/329) attending between 75-100% of sessions. Outcome data were obtained for 85% (418/494) at 12 months where a small, statistically significant negative treatment effect was found in the primary outcome, ADAS-Cog (patient reported), mean difference (MD) -1.4 (95% Confidence Intervals (CI) -2.62, -0.17). There were no treatment effects for any of the other secondary outcome measures for participants or carers: BADLS MD -0.6 (95% CI -2.05, 0.78), EQ-5D-3L MD -0.002 (95% CI -0.04, 0.04), QoL-AD MD 0.7 (95% CI -0.21, 1.65), NPI MD -2.1 (95% CI -4.83, 0.65). There were 4 SAEs reported. The Exercise intervention was dominated in health economic terms.
Limitations
In the absence of definitive guidance and rationale, we used a mixed exercise programme. The inability to mask participants and treating therapists to allocation was unavoidable.
Conclusions
This is a large well-conducted RCT with good compliance to exercise and research procedures. A structured exercise programme did not produce any clinically meaningful benefit in function and HRQoL of people with dementia, or on carer burden
Future work
Should concentrate on approaches other than exercise to influence cognitive impairment in dementia.
| Original language | English |
|---|---|
| Pages (from-to) | 1-201 |
| Number of pages | 201 |
| Journal | Health Technology Assessment |
| Volume | 22 |
| Issue number | 28 |
| DOIs | |
| Publication status | Published - 1 May 2018 |
Bibliographical note
Copyright © and Moral Rights are retained by the author(s) and/ or other copyright owners. A copy can be downloaded for personal non-commercial research or study, without prior permission or charge. This item cannot be reproduced or quoted extensively from without first obtaining permission in writing from the copyright holder(s). The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the copyright holders.Funding
The research reported in this issue of the journal was funded by the HTA programme as project number 09/80/04. The contractual start date was in April 2012. The draft report began editorial review in April 2017 and was accepted for publication in September 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report. This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. © Queen ’s Printer and Controller of HMSO 2018. This work was produced by Lamb et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. © Queen ’s Printer and Controller of HMSO 2018. This work was produced by Lamb et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full programme and will be published in full in Health Technology Assessment Vol. 22, No. 28. See the NIHR Journals Library website for further project information. Additional funding was provided by the Oxford NIHR Biomedical Research Centre and the Oxford NIHR Collaboration for Leadership in Applied Health Research and Care. © Queen ’s Printer and Controller of HMSO 2018. This work was produced by Lamb et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. © Queen ’s Printer and Controller of HMSO 2018. This work was produced by Lamb et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
ASJC Scopus subject areas
- Health Policy
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