Evaluation of a hospital-based day-structuring exercise programme on exacerbated behavioural and psychological symptoms in dementia - the exercise carrousel: study protocol for a randomised controlled trial

Fleiner et al. Trials (2015) 16:228 DOI 10.1186/s13063-015-0758-2 TRIALS STUDY PROTOCOL Open Access Evaluation of a hospital-based day-structuring exercise programme on exacerbated behavioural and psychological symptoms in dementia - the exercise carrousel: study protocol for a randomised controlled trial Tim Fleiner1,2*, Wiebren Zijlstra1, Hannah Dauth2 and Peter Haussermann2 Abstract Background: Conceptual reviews and observational studies describe a link between physical inactivity and behavioural disturbances in people with dementia. Consequently, treatment of these symptoms requires physical activation and pharmacological or physical immobilization should be avoided. The few trials that have been conducted in inpatient dementia care to investigate the effects of exercise on behavioural and psychological symptoms revealed inconsistent results. Due to a lack of evidence, there is a paucity of recommendations for physical activation in this stage of care. Therefore, this trial seeks to investigate the effects of a day-structuring exercise programme on behavioural and psychological symptoms as well as on circadian rhythms of patients with dementia, hospitalized because of their behavioural and psychological disturbances. Methods/Design: A single-centre randomised controlled trial will be conducted in three special dementia care units of an old age psychiatry hospital. Enrolled patients will receive either a 2-week exercise programme, or a 2-week social stimulation programme in addition to usual care. Due to the provision of four day-structuring exercise-sessions in the course of an intervention day, the exercise programme for the study group is called exercise-carrousel. Baseline and post-intervention assessment for the primary outcome variable - the overall effects on behavioural and psychological symptoms - will be measured by the Alzheimer's disease Cooperative Study-Clinical Global Impression of Change. The following objectives are set up as secondary outcomes: dimensions of the behavioural and psychological symptoms of dementia (BPSD) and caregiver burden, routine and on-demand psychotropic medication, patients’ motor behaviour, diurnal cortisol-levels from saliva probes and brain-derived neurotrophic factor-levels from blood serum. Discussion: In order to be regarded as an important treatment option for behavioural and psychological symptoms, physical activation in inpatient hospital dementia care requires more evidence and appropriate recommendations. Respecting hospital routines and the intra-daily variability of the patients’ motivation and behavioural disturbances in the provision of exercise sessions could lead to higher exercise adherence and better effects on patients’ behavioural and psychological symptoms than former trials have presented. The concealment of allocation throughout the trial and the rating of individual exercise exertion present the key challenges and main limitations of this trial. Trial registration: DRKS00006740 (German Clinical Trial Register, date of registration: 28 October 2014). Keywords: Dementia, RCT, Old age psychiatry, Exercise, BPSD, Circadian rhythms, Rest-activity-cycles, Body-fixed motion sensors * Correspondence: 1 Institute of Movement and Sport Gerontology, German Sport University, Cologne 50993, Germany 2 Department of Old Age Psychiatry, LVR-Klinik Köln, Köln 51109, Germany © 2015 Fleiner et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http:// creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Fleiner et al. Trials (2015) 16:228 Background The treatment of behavioural and psychological symptoms of dementia (BPSD) is a key challenge in inpatient dementia care [1, 2]. During the course of the disease nearly every patient suffers from an exacerbation of behavioural and psychological symptoms. Due to extreme caregiver and environmental burden, such phases often lead to admission into specialised Dementia Care Units (DCU) in old age psychiatric departments. The application of antipsychotic medication is a standard treatment method for behavioural disturbances in inpatient dementia care. Owing to potential side effects of neuroleptics [3], clinicians seek non-pharmacological approaches for the treatment of BPSD [4]. A conceptual review [5] and an observational, cross-sectional trial [6] describe a direct link between physical inactivity and increased behavioural disturbances. Considering these findings, more physical activation in DCU is recommended, possibly leading to a reduced use of sedative medication and physical constraints. This non-pharmacological approach shows the positive effects of physical activation and may help to reduce critical side-effects of psychopharmacotherapy. Unlike the good evidence for exercise as a keyfactor in the prevention of dementia [7–9], research focussing on the effects of exercise in dementia care is in its ‘infancy’ [10]. While exercise trials focussing on functional performance and activities of daily living show promising results [11, 12], there is a paucity of clinical trials investigating the effects of exercise on BPSD. While trials in long-term nursing home care reveal promising effects on some BPSD - especially on mood, agitation and circadian disturbances - there are only a few clinical studies in inpatient hospital dementia care with consistent results [13]. The Cochrane Review by Forbes et al. [11] includes only one trial investigating the effects of exercise on BPSD [14]. This 1-year nursing-home exercise trial, conducted with an overall participation-rate of 30 %, showed no effects on BPSD [14]. As the low level of participation and consequently low level of physical activation could be a determining factor explaining only minimal effects on BPSD, future research should focus on approaches with better exercise adherence and higher levels of physical activation [6]. In addition to physical activation, the organisation of non-pharmacological treatment in the course of a day is a key component of inpatient dementia care [15]. Disease-related changes in circadian motor behaviour, that is, wandering, agitation or sundowning, affect almost every patient in advanced stages of dementia [16]. In this context, sundowning is denoted as an increase of BPSD in the late afternoon and early evening hours. As a low level of daytime activity is linked to a higher fragmentation of circadian rest-activity cycles [17], Page 2 of 8 structured exercise programmes may help to synchronise and reduce circadian rhythm disturbances [16, 18]. Taking into account the assumed positive effects of physical exercise on BPSD and the necessity (...truncated)