The design was a multicentred, randomised parallel-group trial comparing a 4-month, supervised, moderate- to hard-intensity exercise training regime with follow-on behavioural support for long-term physical activity change with usual care.
Methods
Participant recruitment and setting
We recruited adults (aged≥18 years) with a diagnosis of any type of dementia and their carers (when available). The dementia needed to be mild to moderate at the time of recruitment. Participants were recruited from 15 regions in the UK.
Approach and initial information
Participants were recruited from four sources:
1. NHS secondary care memory clinics and services: authorised NHS staff identified potential participants using electronic or case record searches to screen for eligibility. The lists were reviewed by a clinician involved in the clinical care of the participant and checked for patients who should be excluded. Potential participants and their carers were approached by their clinician or authorised NHS staff member either face to face at a clinic or by letter.
2. General practice registers of people with dementia: general practices searched their registers of patients to identify people with a diagnostic code for dementia. In most practices, this was done by a search of databases using Read Codes or Quality Outcomes Framework codes. General practitioners approved the final list of names and sent invitation letters to potential participants.
3. Research network participant-interested databases [e.g. the Dementia and Neurodegenerative Diseases Research Network (DeNDRoN); Join Dementia Research]: the UK Department of Health and Social Care has funded a number of networks and projects to enable people with dementia to register their interest in participating in research and to enable a rapid and simple approach. Participants were identified by a nursing or clinical staff of DeNDRoN from these databases. Participants deemed as meeting the inclusion criteria were contacted by DeNDRoN staff by telephone to explain the study and, if potentially eligible, sent an invitation letter.
4. Other dementia resources (e.g. Alzheimer’s cafes): we approached community-based dementia resources directly to determine if they were willing to approach potential participants. When service providers agreed and approached potential participants, a researcher from the team then visited the centres and provided further explanation about the study to potential participants and their carers. When participants or carers were interested, the researcher assessed their potential eligibility and contacted their health-care provider to confirm eligibility.
All procedures were consistent with relevant legislation to ensure data confidentiality. All invitations were accompanied by written information about what was involved in the study, supplemented by a verbal explanation when the opportunity arose. In all instances, the participants indicated their potential willingness to participate by sending a reply slip to either the local co-ordinating centres or the research office at the University of Warwick Clinical Trials Unit (WCTU) (depending on the local set-up). Once a participant confirmed their willingness to participate, they were contacted by a member of the recruitment team (a registered nurse or allied health professional with appropriate research training) to further assess eligibility and explain the trial. In all instances, participants received the written and verbal information and were given a minimum of 48 hours to decide whether or not they wished to join the trial. Potential participants were visited in their own homes to record consent in writing and to confirm eligibility [Standardised Mini Mental State Examination (sMMSE) score and functional abilities]. A baseline assessment was carried out and the participant was registered and randomised.
Eligibility criteria
Participants were required to:
1. have probable dementia according to the DSM-IV criteria1
2. have probable MMD (a score of>10 on the sMMSE)65
3. be able to participate in a structured exercise programme determined by: i. being able to sit in a chair and walk 10 feet without human assistance
ii. having no unstable medical conditions, for example unstable angina, or acute or terminal illness 4. live in the community, alone or with a friend, relative or carer, or in sheltered accommodation.
Consent
People with MMD may lack the necessary mental capacity to provide fully informed consent. All potential participants were assessed for their capacity to consent by the registered research nurses or physiotherapists conducting the baseline visit. All nurses and physiotherapists were trained specifically in assessing and taking consent in trials recruiting people with dementia using the principles of theMental Capacity Act 2005.66
Training was provided by the NIHR Clinical Research Network or DeNDRoN and/or the lead research physiotherapist responsible for recruitment. When potential participants were assessed as having capacity, informed consent was obtained from the individual. If potential participants were assessed as lacking capacity, agreement to participate was still sought from these individuals. In this situation, additional advice would be sought from the primary carer or personal consultee on whether or not the person who lacked capacity should take part in the project and what their past and present wishes and feelings would have been about taking part. If participants were unable to give informed consent, and for whom no personal consultee was available, a nominated consultee (e.g. health-care professional) who was well-placed and prepared to act on behalf of the potential participant was sought. When a potential participant lacked capacity to provide informed consent, and a nominated consultee could not be found, that person was not recruited. Agreement for continued participation was checked at each follow-up visit. Consent was sought from carers, for the data on carers, after consent for participation had been secured from the person with dementia.
Risks and benefits
All participants had access to usual care, and thus no treatment was withheld from trial participants. There is some limited evidence of a very small increased risk of injury as a result of becoming more physically active. In our physical activity programme, however, health-care professionals tailored progressive exercises to individual need/ability and delivered the programme to small groups of participants in a supervised and safe context.