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Dementia And Physical Activity (DAPA) trial of moderate to high intensity exercise training for people with dementia: randomised controlled trial

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1675 (Published 16 May 2018) Cite this as: BMJ 2018;361:k1675 Visual abstract, showing the study population, design and primary outcomes.
  1. Sarah E Lamb, professor1 2,
  2. Bart Sheehan, consultant liaison psychiatrist3,
  3. Nicky Atherton, specialist physiotherapist3,
  4. Vivien Nichols, research associate2,
  5. Helen Collins, research delivery manager4,
  6. Dipesh Mistry, statistician2,
  7. Sukhdeep Dosanjh, trial manager2,
  8. Anne Marie Slowther, reader5,
  9. Iftekhar Khan, health economist2,
  10. Stavros Petrou, professor of health economics2,
  11. Ranjit Lall, principal research fellow in statistics2
  12. on behalf of the DAPA Trial Investigators
  1. 1Centre for Rehabilitation Research and Centre for Statistics in Medicine, Nuffield Department of Orthopaedics Rheumatology & Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford OX3 7LD, UK
  2. 2Warwick Clinical Trials Unit, University of Warwick, Coventry, UK
  3. 3Coventry and Warwickshire Partnership Trust, Coventry, UK
  4. 4Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK
  5. 5Division of Health Sciences, University of Warwick, Coventry, UK
  1. Correspondence to: S E Lamb sarah.lamb{at}ndorms.ox.ac.uk
  • Accepted 28 March 2018

Abstract

Objective To estimate the effect of a moderate to high intensity aerobic and strength exercise training programme on cognitive impairment and other outcomes in people with mild to moderate dementia.

Design Multicentre, pragmatic, investigator masked, randomised controlled trial.

Setting National Health Service primary care, community and memory services, dementia research registers, and voluntary sector providers in 15 English regions.

Participants 494 people with dementia: 329 were assigned to an aerobic and strength exercise programme and 165 were assigned to usual care. Random allocation was 2:1 in favour of the exercise arm.

Interventions Usual care plus four months of supervised exercise and support for ongoing physical activity, or usual care only. Interventions were delivered in community gym facilities and NHS premises.

Main outcome measures The primary outcome was score on the Alzheimer’s disease assessment scale-cognitive subscale (ADAS-cog) at 12 months. Secondary outcomes included activities of daily living, neuropsychiatric symptoms, health related quality of life, and carer quality of life and burden. Physical fitness (including the six minute walk test) was measured in the exercise arm during the intervention.

Results The average age of participants was 77 (SD 7.9) years and 301/494 (61%) were men. By 12 months the mean ADAS-cog score had increased to 25.2 (SD 12.3) in the exercise arm and 23.8 (SD 10.4) in the usual care arm (adjusted between group difference −1.4, 95% confidence interval −2.6 to −0.2, P=0.03). This indicates greater cognitive impairment in the exercise group, although the average difference is small and clinical relevance uncertain. No differences were found in secondary outcomes or preplanned subgroup analyses by dementia type (Alzheimer’s disease or other), severity of cognitive impairment, sex, and mobility. Compliance with exercise was good. Over 65% of participants (214/329) attended more than three quarters of scheduled sessions. Six minute walking distance improved over six weeks (mean change 18.1 m, 95% confidence interval 11.6 m to 24.6 m).

Conclusion A moderate to high intensity aerobic and strength exercise training programme does not slow cognitive impairment in people with mild to moderate dementia. The exercise training programme improved physical fitness, but there were no noticeable improvements in other clinical outcomes.

Trial registration Current Controlled Trials ISRCTN10416500.

Footnotes

  • Contributors: SEL (chief investigator): conceived and designed the study and had overall responsibility for the study design and delivery. She is the guarantor. DM did the statistical analysis. NA developed and implemented the intervention and was training and quality assurance lead for the intervention. SD was responsible for the trial logistics and management, and writing and reviewing of the manuscript. IK was responsible for the economic analysis of the trial. RL is a grant holder and was responsible for the statistical analysis. HC was responsible for recruitment and guidance on strategies for recruitment and testing procedures. AMS is a grant holder and lead ethicist and provided the framework for consent and advice and guidance on ethical issues during the trial. VN was responsible for trial management and was the recruitment lead and was responsible for training and quality assurance. SP is a grant holder and was responsible for the economic analysis and writing and reviewing of the manuscript. BS was responsible for study design and conduct, clinical responsibility, and writing and reviewing of the manuscript. All authors have contributed to drafting the manuscript and approving the final version. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding: This trial was funded by the National Institute for Health Research (NIHR Health Technology Assessment programme 09/80/04) and received additional support from the NIHR Local Clinical Research Networks and NIHR Oxford CLAHRC and Biomedical Research Centre. NIHR funded the study. It developed a commissioning brief but had no role in the study design, data acquisition, analysis, or manuscript preparation. The chief investigator (SEL) assumes overall responsibility for the data in the manuscript. All named investigators had full access to the trial dataset. There are no contractual agreements that limit access for investigators. Companies and the sponsor (University of Warwick) had no role in the funding, design, analysis, or interpretation. The views expressed are those of the authors and are not an official view of the institutions or funders.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work, other than funding arrangements for the trial described in body of the text; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was approved by national ethics review committees (REC No 11/SW/0232) and research governance departments in each organisation.

  • Data sharing: The relevant anonymised patient level data, full dataset, technical appendix, and statistical code are available on reasonable request from the corresponding author. Consent for data sharing was not obtained but the presented data are anonymised and risk of identification is low.

  • Transparency: The lead author (SEL) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

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