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

Abstract

BackgroundConceptual 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/DesignA 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.DiscussionIn 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 registrationDRKS00006740 (German Clinical Trial Register, date of registration: 28 October 2014).

Structured physical exercise improves neuropsychiatric symptoms in acute dementia care: a hospital-based RCT

“…Pre and post assessment was conducted 3 days before and after the intervention respectively. For further details, refer to the study protocol published previously [ 13 ]. The RCT has been registered in the German Clinical Trial Register (DRKS00006740) and has been approved by the local ethics committee.…”

“…The following inclusion criteria were applied: diagnosis of dementia according to ICD-10 [ 14 ]; a minimum length of stay of 1 week before enrollment into the study in order to help patients become familiarized with the ward setting and to exclude delirium; clinical exclusion of delirium based on the validated German version of the Confusion Assessment Method [ 15 , 16 ]; ability to perform the Timed Up and Go Test [ 17 ]; and written informed consent from the patient’s legal guardian as well as from the patient, if possible. According to the sample size calculation published in the study protocol [ 13 ], each group should include 53 patients respectively. Therefore, an enrollment of 130 patients was planned.…”

“…The IG conducted an ‘exercise carrousel program’ for 2 weeks [ 13 ]. On 3 days per week, four 20-min exercise sessions per day were conducted.…”

“…Within the day-structuring exercise schedule, strengthening exercises with ankle or wrist-worn weights or endurance exercises for lower and upper limbs on seated ergometers were carried out in groups of three patients. Exercise protocols with instructions, repetitions, intensity, individually tailoring of the exercises, and recording of the exercise adherence have been reported in the study protocol [ 13 ].…”

Alzheimer’s Disease: Dawn of a New Era?

“…However, a recent clinical trial showed no significant effect of donepezil treatment on BDNF levels (166), while a 2009 clinical trial have indicated an increase in BDNF levels in lithium-treated patients with early AD (167). BDNF levels have been analyzed as a biomarker in other clinical trials conducted on AD treatment, especially in trials on the effect of physical activity and exercise on AD (168)(169)(170). Beneficial effect of BDNF in several mouse models of AD has also been reported.…”