Abstract
Physical exercise is an effective treatment approach for neuropsychiatric symptoms (NPS), but it is unknown whether the reduction of NPS has an impact on professional caregiver’s burden. A randomized controlled trial in acute dementia care with N = 70 patients, n = 35 per group, was conducted. The intervention group (IG) received an exercise program, the control group a social stimulation program. The RM-ANOVA showed a significant group x time interaction with time effects for the IG and decreased caregiver burden due to the exercise program at follow-up. Physical exercise programs may not only be beneficial for the patients but also for their professional caregivers.
Keywords
INTRODUCTION
Neuropsychiatric symptoms (NPS), including psychotic, emotional, behavioral, and neurovegetative signs, in patients suffering from dementia cause tremendous caregiver burden. Therefore, NPS are the main reason for admission to acute dementia care units in hospitals or nursing homes [1, 2]. The first-line treatment options for NPS are non-pharmacological approaches, such as patient-centered care, milieu therapy, and psychosocial interventions [3, 4]. Physical inactivity is linked to increased NPS [5, 6]; therefore, exercise programs are implemented in dementia care and show clinically significant results in ameliorating NPS [7–9].
Despite the growing evidence on the effects of physical exercise on the NPS of patients, it is not clear if such programs also reduce caregiver burden [10]. Up to now, no hospital-based randomized controlled trials have been conducted, investigating the impact of exercise programs on the perceived burden of professional caregivers. Therefore, the aim of this trial is to analyze whether or not, a structured exercise program effects professional caregiver burden caused by NPS.
METHODS
Study design
A one-year randomized controlled trial was conducted in three specialized acute dementia care wards of a psychiatric hospital. Patients were randomly assigned to an intervention group (IG) or a control group (CG) who received special treatment for a period of two weeks. Additional trial information is published in a study protocol [11], and primary analyses regarding the effects of the exercise program on the NPS of patients have been reported [12]. This trial has been approved by the ethics committee of the Medical Chamber Northrhine (reference number: 2014216) and the ethics committee of the German Sport University Cologne. Written informed consent from the patient’s legal guardian as well as from the patient, if possible, has to be given to include a patient. The trial was registered in the German Clinical Trial Register with number DRKS00006740.
Patients and professional caregivers
Patients with an ICD-10 diagnosis of dementia were included if they were able to perform the Timed Up and Go Test and written consent from the legal guardian of the patient as well as from the patient were obtained. Based on the Confusion Assessment Method, delirium was excluded [13]. All patients received a person-centered care approach [14], with a specialized nurse assigned to each patient during the hospital stay. This primary nurse was considered as the patient’s professional caregiver.
Instruments
Professional caregiver burden as caused by the NPS of patients was measured using the Neuropsychiatric Inventory (NPI) [15] at baseline (T0) and after the two-week intervention period (T1). The NPI assessment of perceived caregiver burden consists of 12 psychopathological domains, each ranked with a 5-point scale: 0 points indicating no caregiver burden and 5 points indicating maximum caregiver burden. The NPI caregiver burden total score ranges from 0-60 points, with 0 indicating no perceived caregiver burden. According to Mao and colleagues, a change of±3.95 points can be considered as a minimal clinical important difference (MCID) in the caregiver’s burden [16]. The NPI was applied by blinded investigators interviewing the patient’s primary nurse. The blinded investigators, as well as the patient’s primary nurse were not part of the intervention.
All further instruments used to characterize the study sample and investigate the effects of the NPS of patients are presented in detail in the study protocol [11].
Interventions
Patients assigned to the IG received a special exercise program called “exercise-carrousel” in addition to treatment as usual (TAU). Within the two-week study period, patients from the IG were offered to participate on three days per week in four short-bout exercise sessions (20 min) per day. These exercise sessions were conducted in groups of up to three patients and included strengthening as well as endurance exercises [11].
In addition to TAU, which included exercise therapy (two times 45 min/week), the CG received a social stimulation program with attended table games lasting 120 min/week in addition to TAU.
Analysis
The effects on perceived caregiver burden as measured with the NPI were treated as metric values. A two-way repeated measurement ANOVA was conducted with a group x time interaction. Paired and unpaired t-tests were used as post-hoc tests. The level of significance was set at p < 0.05.
RESULTS
From a total of 224 patients assessed for eligibility in the trial, 85 patients were allocated to the IG (n = 46) and the CG (n = 39). Due to early hospital discharge (n = 14) and refusal to continue the intervention (n = 1), a total of 70 patients were finally included in the follow-up measurement with 35 in each group, respectively.
The sample characteristics are illustrated in Table 1.
Patients’ characteristics
Patients’ characteristics are presented as mean (M), standard deviation (SD), minimum (Min) and maximum (Max) for continuous variables and n (%) for categorical variables. Statistical differences (p) between the groups were calculated by χ2-test for nominal data and t-test for continuous variables. NPI, Neuropsychiatric Inventory.
The results on perceived professional caregiver burden are presented in Fig. 1. The repeated measurement ANOVA showed a significant group x time interaction (F(1,68): 5.94; p = 0.02) for the results in the NPI caregiver burden scale. The post-hoc analysis revealed significant time effects for the IG (t(34)=5.68, p < 0.01; d = 1.01, 1-β=0.99) but not for the CG (t(34)=–1.11, p = 0.27; d = 0.22, 1-β=0.24). The comparison at T0 indicated no group differences (t(68)=1.02, p = 0.31; d = 0.24, 1-β=0.26), but significant differences between both groups at T1 (t(68)=-2.23, p = 0.03; d = 0.39, 1-β=0.49) were observed. The analysis of the NPI symptom clusters revealed no significant group x time interaction.
Measurement of caregiver burden at baseline (T0) and follow-up (T1), n = 35 in each group. NPI, Neuropsychiatric Inventory (0-60 points, 0 indicating no perceived caregiver burden).
DISCUSSION
The aim of this analysis was to investigate whether a structured physical exercise program had an impact on perceived professional caregiver burden in acute dementia care.
The results showed a significant reduction of perceived caregiver burden due to participation in an exercise program. Adding a social stimulation program to the TAU, as applied to the CG, led to a slightly improvement from M = 8.5 points (SD = 4.0) at T0 to M = 7.1 points (SD = 4.8) at T1, but no significant and clinical relevant changes of the perceived caregiver burden during the study period [16]. The exercise program showed an amelioration of perceived caregiver burden in the IG with a significant time effect and group difference at T1 (Fig. 1). The perceived caregiver burden of the IG improved from M = 9.8 points (SD = 5.1) at T0 to M = 4.7 (SD = 4.0) at T1. These changes can be seen as clinical relevant, as they are higher as the MCID [16]. The reduction of perceived caregiver burden was directly related to the reported clinically relevant effects on the NPS of patients [12]. Furthermore, there was a comparable level of social stimulation, and there was no significant difference regarding the level of sedative and neuroleptic medications between both groups [12]. Although the patients’ primary nurses were not part of the intervention and blinded to the group allocation, a putative loss of this blinding within clinical routine care was possible. This potentially limits the presented findings.
According to the sample characteristics (Table 1), the patients can be classified as a geriatric patient population (Age M = 80 years, SD = 6) with an overall moderate stage of dementia (MMSE M = 18.3 pt, SD = 4.8). Both, the level of perceived caregiver burden (NPI M = 9.1, SD = 5.5) and the level of the NPS of patients (NPI M = 22.5, SD 13.0) were comparable to other studies (e.g., the report by Huang and colleagues on patients in a memory clinic suffering from dementia with moderate NPS (NPI M = 20.3, SD = 21.0)) and low level of perceived caregiver burden (NPI M = 8.8, SD = 10.9). To our knowledge, n = 3 trials have been conducted investigating the effects of physical exercise on caregiver burden in patients suffering from dementia. The trials have been conducted in the community, with a sample size ranging from 16 to 40 and an intervention period ranging from 3 to 6 months [17–19]. Although these trials showed positive results at first, there were limitations regarding data acquisition, study quality and sample size [10].
Conclusions
This is the first trial to investigate the effects of a short-term physical exercise intervention on perceived professional caregiver burden in acute dementia care. The results of this trial reveal not only a clinically significant decrease of the NPS of patients but also a decrease of the perceived caregiver burden of these NPS. Along with growing evidence about the important role of physical activity in dementia care, the results of this trial further indicate to the necessity of implementing structured physical exercise programs in dementia care. This approach will ameliorate the impact of NPS on both, the patients themselves and their caregivers.
Footnotes
ACKNOWLEDGMENTS
The authors would like to thank all participants and their legal guardians and the board of directors and staff members of the LVR Hospital Cologne.
This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.
