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.
Original language | English |
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Article number | k1675 |
Journal | BMJ (Online) |
Volume | 361 |
DOIs | |
Publication status | Published - 2018 |
Bibliographical note
Funding Information:DAPA Trial Team: S Alleyne, S Hennings, F Griffiths, S Bridgewater, E Eyre, S Finnegan, L Hall, P Hall, H Johnson, G Kaur, L Langdon, S Lyle, J Lowe, S Mathews, J Millichap, J Nussbaum, I On-kar, C Ritchie, V Russell, G Scott, S Shore, K Spanjers, L Stonehewer, M Thorogood, J Todd, A Ullah, H Waters, L Woods, E Withers, P Zeh, A Bond, D Brown, C Byrne, R McShane, N Thomas, J Thompson, C Dransfield, F Le Frenais, C Hall, O Rye, R Carson, M Clarke, H Eaton, H Ellis, A Farrand, S Gardner, C Harducas, L Rigby, J Wilson, L Hill, L Johnson, L Lord, L Johnson, T Qassam, S Sadier, A Shipman, L South, J Statham, J Tomkins, D Weaver, B Coope, D Craddock, A Johal, J Lee, J Lindsay, J Tucker, R Vanderputt, V Cross, G Glithens-Mather, L Martin, C O’Reilly, E Rogers, R Sheridan, K Birtwell, J Brooke, A Davis, C Hinze, S Hussain, A Kennedy, H Mistry, R Noble, R Norton, E Oughton, V Sherwin, P Tinker, D Glancey, H Karrin, M Marudkar, G Borley, T Crisp, P Koranteng, A Lovesy, S Vogel, B Browne, L Colbourn, A Feast, E Hanratty, R Legerd, R Niland-Smith, T Sullivan, T Sullivan, A Streater, H St Roas, M Anderton, R Blake, K Brown, S Marriott, S Simpson, A Thornhill, L Colbourn, F Dawe, T Kuruvilla, L Moore, R Niland-Smith, M Phillips, G Riley, and A Uthup 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.
Publisher Copyright:
© 2018 Published by the BMJ Publishing Group Limited.
ASJC Scopus subject areas
- General Medicine