Summary of findings
The study aimed to establish whether it was feasible to run a cluster RCT across day centres, community groups and care homes. Results neither support nor refute the effectiveness of the CCBE intervention as this was not the purpose of the trial. Although recruitment was challenging and required more staff than was originally anticipated, centres and older people were interested in taking part in the study and it was possible to recruit centres and older people to participate in the trial. The Timed Up and Go Test and gait speed markers appeared to identify older people with activity limitations who were appropriate for the CCBE intervention. Forty percent of participants withdrew from the study primarily due to stopping attending the centres indicating the trial design would need to be revised to follow up participants at home. Outcomes of well-being, grip strength, quality of life and resource could be collected. Further exploration is required to establish the most appropriate lower limb outcome for this population.
This feasibility study also explored the acceptability and feasibility of delivering the CCBE intervention. In the day centres and community groups the CCBE could be delivered in a group format once a week (in line with the expert consensus) and twice a week in care homes. The CCBE intervention was largely accepted by older people and staff at the centres. Older people focused on the social benefits of group activity and having something to look forward to and take part in. Older people also wanted to try more standing and walking exercise but were not confident in their ability to do so. Staff reported the CCBE was appropriate and enabled safety of older people with physical limitations.
This feasibility study has established areas where a future trial design would need to be revised to maximise retention of participants as well as maximise delivery of the CBBE intervention.
Strength and limitations
The main limitation of this study is that we have tested the feasibility of a particular planned trial, using our version of CCBE, to a specific patient group and with the specific attention control of group reminiscence. There may be different patient groups, different versions of CBE and different settings that have not been included here and the findings of this study may have limited generalisability in those contexts. This study has however met its objective of addressing the feasibility of the CCBE intervention and trial design.
The views of the older people captured through semi-structured interviews are from those who were allocated to the CCBE group and may not be representative of all older people. Due to capacity it was not possible to interview all the older people who took part in the control groups or those older people not eligible to take part in the study, however, their views may have offered further insight into appropriate exercise interventions in these settings. The lack of recruitment to consultee interviews limits the findings of this component of the study and further work is needed to explore this perspective.
Implications
This study has explored the delivery of the CCBE intervention in complex environments and it is important to acknowledge the difficulties of conducting research and delivering interventions in these settings.
The CCBE intervention could be delivered once a week in the day centres and community groups which was supported by the expert consensus which stated sessions should be delivered at least once a week [
5] This frequency of delivery is however not supported by the wider exercise literature for frail older people which indicates higher frequencies are needed to elicit physiological change [
17,
18]. Previous work in care home residents has identified issues with delivering exercise interventions at appropriate frequencies with Chin a Paw [
19] concluding that exercise programmes that are delivered less than twice a week are not sufficient to elicit functional gains, however supporting participation twice a week was challenging.
The CCBE in this study was delivered in a group format at centres with existing infrastructure and where older people already attended. Using these established centres compromised the delivery of the CCBE at higher frequencies and further work is needed to explore alternative delivery formats. One-to-one sessions offered at participant’s homes, setting up additional community group as well as at the existing centres may facilitate increased frequencies. For a future trial where physical outcomes are targeted the delivery model of CCBE would need to be revised to ensure delivery at a minimum of twice a week. This delivery model would require more resources (therapists, equipment) and the cost implications would need to be considered by the trial evaluation.
As the CCBE intervention was intended for those older people with compromised health and mobility it is unsurprising that health status was a barrier to engagement and progression of the exercise programme. This supports the wider views of older people who identify physical ailments as a potential barrier to long-term exercise engagement [
20]. Interventions may need a high degree of tailoring to account for individual health conditions and preferences of older people. Overly structured and prescriptive programmes that do not allow for changes to the delivery may be limited for this population. With this degree of flexibility and variation in delivery it is important that the CCBE intervention is delivered by a professional who has experience and skills to meet the needs of the older people in this study.
Older people enjoyed participating in the CBE programme, however, some participants expressed a preference to progressing to standing and walking if they are able. Progressing to supported and unsupported standing exercise was also considered valuable by experts [
5]. Other exercise programmes developed for older people have used CBE as the starting point for participants with poor mobility [
21] however there is a lack of detail over whether participants progressed to supported and free standing exercises within these studies. Progression to supported standing exercises following a chair based programme was found to be achievable in a small feasibility study with community dwelling older people [
22]. Further work is needed to develop the CCBE intervention to actively support progression to standing and walking programmes if this is achievable by the participant.
At once a week it may be reasonable to consider the CCBE intervention as a way of promoting general well-being with limited influence on physical measures of muscle strength and mobility. This study demonstrated that it was feasible for a future trial to focus on psychological aspects such as well-being and quality of life and this was supported by the views of the older people who participated. Previous research such as the large (
n = 1054) OPERA trial [
23] has evaluated a range of physical activity interventions in care home residents and concluded that there was no effect on mood and depression. This trial suggested that measuring well-being may be more appropriate for exercise interventions and we found that the Warwick Edinburgh Well-Being Scale was able to be completed in this study. A trial of CCBE with the primary focus on well-being could be delivered once a week in a group format and for this outcome it would be appropriate to compare it with an active control. Group reminiscence was demonstrated to be an acceptable active control for this population and has been used successfully in previous care home research [
24].
Although there has been an increase in research conducted in care homes [
25], the other types of centres in this study (day centres and community groups) have not frequently been exposed or involved in clinical research. It was encouraging that these centres were interested in taking part in research that can support older people as the services for older people are increasingly being supported by the third sector. Non-NHS sites fall outside of traditional governance frameworks and time needs to be planned to obtain agreements from each centres taking part. Traditional participant information sheets for clinical trials are often expected by ethical committees and research governance teams and these can be a deterrent to recruitment for studies in these settings. There is a need to consider the study processes and information to ensure they meet the needs of the participants and settings. Consideration of appropriate governance procedures and information that is appropriate to the setting would be needed to maximise recruitment and reduce the burden to centre staff and participants.
The process of randomisation was explored in this study in preparation for a definitive randomised controlled trial. Although there was no drop out of centres due to allocation some centres who were allocated to receive usual care expressed concern over the burden of the research for little immediate gain. Given the propensity for bias in this field, we argue that the most robust information about effectiveness will come from high quality RCTs and therefore considered an RCT to be the most appropriate form of definitive evaluation for the CBE intervention. The high dropout rate of participants in this study, the flexible delivery and the difficulties engaging centres in the control arm may however suggest alternative evaluation methods. Recruitment and follow up of participants should include home based assessments to allow follow up of participants who no longer attend the centre and to ensure minimal disruption to centre activities.