Provision of group exercise classes over 12 months to residents of care homes older than 65 years had no effect on depressive symptoms in this population, as measured by the GDS-15, irrespective of whether residents were depressed at baseline.
This is a large cluster randomised trial with robust findings. The results are clear and conclusively negative. Although uptake of the intervention was very good we recorded no evidence of any benefit on any of our primary or secondary outcome measures. The limits of the 95% CIs for the possible benefit from the intervention for cohort and depressed cohort analyses exclude the likelihood of a clinically important effect. Furthermore, in our cost–utility analysis the intervention was dominated by the control, showing that this is not a cost-effective intervention (appendix p 7
Participating homes were broadly representative of UK care homes, and participant baseline characteristics were much the same as population values.8,22,23
That nearly half of our participants were depressed, and that only a quarter of these cases were identified as depressed in care-home records underscores the relevance of depression as an important and neglected health problem needing treatment (appendix p 2
A quarter of residents were excluded by care-home managers because their health was very poor, or because of concerns that approaching the resident might cause distress (). Residents excluded because of very poor health would have been unlikely to be able to participate in the exercise groups and thus unlikely to benefit from the intervention.
Prevalence of depressive symptoms between baseline and follow-up did not differ in either group suggesting that both control and active interventions were ineffective. Also, the pattern of use of antidepressant drugs, or mental health team visits, did not differ, which might have masked a beneficial effect from the intervention (appendix p 3
These findings effectively exclude any possibility of a beneficial effect on depressive symptoms, as measured on the GDS-15, from this exercise intervention. We have not excluded the possibility that our intervention might improve mobility; the limits of the 95% CI for the improvement in the SPPB in both the cohort analysis (–0·05 to 0·64) and the cross sectional analysis (–0·10 to 0·58) include a minimum clinically important difference of 0·5.24,25
We are aware of one other cluster randomised trial (N=191, follow-up 6 months) and one individually randomised trial (N=134, follow-up 1 year) in care homes of exercise programmes that were much the same as ours with participants who had similar characteristics to ours.26,27
These studies also failed to show a benefit on depressive symptoms (panel
). We are aware of two other trials in care homes that excluded people with substantial cognitive impairment. One (N=389) showed no benefit on depressive symptoms from Tai Chi while the other (N=82) did find a benefit on depressive symptoms from qigong.28,29
Panel. Research in context
We have done three relevant systematic reviews to identify randomised controlled trials comparing the effect of an exercise intervention on depressive symptoms with usual care or an attention control in elderly residents of care homes. First, we updated our review of the effects of exercise on depression in elderly people.3
Search terms were: “exercise” OR “exercise therapy” OR “physical activity” OR “physical exercise” OR “dancing” OR “Tai Chi” OR Tai Ji OR “walking” OR “yoga” OR “physical fitness” OR “aerobic exercise” OR “exertion” AND “depression” OR “dysthymic disorder” OR “depressive disorder” OR “major depressive disorder” OR “depressive disorder major” OR “dysthymia” AND “elderly” OR “aged” OR “geriatric” OR “seniors” AND “randomised controlled trials”. Second, we updated our review of physical activity or the effects of physical activity on elderly people with dementia.5
Search terms were: “exercise” OR “exercise therapy” OR “physical activity” OR “physical exercise” OR “dancing” OR “Tai Chi” OR Tai Ji OR “Walking” OR “yoga” OR “physical fitness” OR “aerobic exercise” OR “exertion” AND “elderly” OR “Aged” OR “geriatric” OR “seniors” AND “dementia” OR “Alzheimer disease” AND “randomised controlled trials”. Finally we updated our unpublished systematic review of cluster randomised controlled trials in residential and nursing homes. Search terms were “randomised trial” OR “clinical trial” AND “long term care facility” OR “long term care” OR “assisted living” OR “group homes” OR “homes of aged” OR “residential facilities” OR “nursing home” OR “retirement homes” OR “retirement communities” AND “cluster randomisation” OR “cluster randomisation” OR “cluster” OR “clustered” OR “clustering” OR “clusters” OR “group-randomised” OR “group-randomised” OR “randomisation unit” OR “randomisation unit”. Our searches were done in Scopus and PubMed, for papers reported between Jan 1, 2010, to Feb 13, 2013. We indentified four relevant studies; Tsang and colleagues,28
Rolland and colleagues,27
Conradsson and colleagues,26
and Lam and colleagues.29
The populations included the trials by Tsang and colleagues28
and Lam and colleagues29
differ from our participants because they excluded residents with substantial cognitive impairment. Both the populations included, and the frequency and intensity of the exercise sessions, in the studies by Rolland and colleagues27
and Conradsson and colleagues26
are much the same as those in our trial. Neither, however, included a whole home component to the intervention.
Taken together with the earlier findings of Rolland and colleagues27
and Conradsson and colleagues,26
our findings show that regular moderately intense group exercise sessions do not live up to their promise as a treatment for depression in elderly residents of care homes. Nevertheless, exercise might be useful treatment for depression in fitter older people, including residents of care homes, who do not have substantial cognitive impairment and who are able to achieve more intense levels of sustained physical activity.
The whole home nature of the active intervention meant that masking data collection within the homes after randomisation was not possible. Also support from care-home staff with data collection might differ between intervention and control homes. In intervention homes we noted a consistent trend for the collection of more post-randomisation data. Our findings did not, however, change materially in a sensitivity analysis in which we imputed missing data or when an extreme scenario sensitivity analysis was done (data not shown).
The prevalence of depression in all residents at the end of the study is an important analysis to ensure the findings apply to all residents rather than only relatively healthy survivors. In this analysis we recruited more participants in the intervention homes than in the control homes after randomisation. Results were, however, unchanged by excluding the post randomisation participants. Since this is one of the largest trials done in a care-home setting and intra-cluster correlation coefficients are mostly close to zero, we achieved precise estimates for our effect sizes, suggesting that our conclusions are robust.
We designed an intervention package that had a good theoretical grounding designed to be delivered, over the long term, in a care-home environment. Participants had good exposure to the exercise sessions without any serious adverse events. The session design included ambulatory exercises, but because of the poor physical health and abilities of participants in the exercise group, the exercises were largely done while seated, reducing the intensity of the exercises. In a parallel process assessment we noted that our intervention had little effect on physical activity within homes outside the times of exercise sessions8
and that although overall session attendance was good, many participants, particularly those with depression, attended too few sessions to gain the anticipated benefits. Our approach, although popular with the homes, does not seem to have delivered an adequate dose to those with greatest need. Exercise interventions targeted at the fittest, least cognitively impaired care-home residents with depression could be effective.28–32
We have achieved very precise estimates of the possible effect of the intervention. The study is, however, limited by the sensitivity of the measures used. Other, more sensitive, outcome measures might have shown a benefit, particularly for health-related quality of life. Nevertheless, this large study shows that group exercise is unlikely to be an effective approach for prevention and treatment of depression among elderly residents of care homes. We cannot exclude the possibility that this intervention had beneficial effects on other unmeasured outcomes such as cardiovascular fitness or staff morale within care homes.
Despite robust methodology, a strong theoretical grounding and good uptake of a moderately intensive exercise intervention, we identified no evidence that our intervention had a positive effect on any of our carefully selected primary or secondary outcomes. This evidence does not support the use of this type of intervention to reduce the burden of depressive symptoms in residents of care homes, and alternative strategies for this common and important problem are needed.