Different types of dementia and cardiovascular diseases (CVD) are the most important health problems in elderly people. In Spain, ischemic heart disease is the main cause of losing years of life adjusted by disability in men, while the main cause in women is dementia . The aging of the population has led to an increase in chronic diseases and disabilities. It has become necessary for relatives to dedicate more time in caregiving, especially women. This makes it a requirement to incorporate a gender perspective into the contents of this research about these diseases. For all these reasons it is important to find strategies to help patient with dementia (PWD) or with CVD and their relative caregivers (RC).
Treatment of people with dementia
Nowadays it is recommended to approach the treatment of dementia with a multifactorial focus that includes both pharmacological and non-pharmacological interventions . Pharmacological treatments of PWD principally address to cognitive impairment. Cognitive impairment constitutes the most relevant demonstration of dementia and it’s tend to be associated to different symptoms that affect the individual’s functional abilities, which interfere with the habitual activities and reduce their quality of life (QL) and the QL of their caregivers [3–5]. It has been found that some drugs can help delaying the development of behavioral symptoms and that these drugs can contribute in a substantial way to improve the QL of the patients, their relatives, and their caregivers. But it has also been observed that the administering of antipsychotics in PWD can increase the mortality and the risk of cerebrovascular accidents . A recent review  concludes that the non-pharmacological therapies (NPT) can be a useful, versatile and potentially cost-effective tool to improve clinical demonstrations and the QL of the PWD, as well as the caregiver. In respect to the cognition results, functionality for the Basic Activities of Daily Living (BADL), behavior and mood, the magnitude of the effect achieved with different NPTs is similar to that observed with the use of drugs. Due to the widespread absence of secondary effects and its flexibility to be adapted to individual cases, the NPTs should be the first choice of therapy to improve the functionality of the BADL or to modify specific behaviors [2, 7].
Non-pharmacological therapies: physical activity
Several randomized clinical trials (RCTs) in PWD have shown that physical activity (PA) is a beneficial intervention for healthy older people, because it may increase the functional capacity, control for cardiovascular risk factors and slow the progression of cardiovascular disease [8, 9]. It is emphasized in the reviews on the NPTs in dementia [2, 10], that there is a need to carry out major RCTs in the area of physical exercise. In various RCTs with PWD, PA seems to provide benefits for the QL, problematic behaviors, depression, functionality, and falls [11, 12], but they do not find evidence that it will improve CVD in the long-term. Nevertheless, recent results are encouraging [13–15] because they suggest a potentially beneficial relationship between physical activity and cognitive function, and they are designing new trials that may help clarify this issue [16–20]. Baker et al.  found that there was improvement in the executive control in sedentary women with CVD after six months of high intensity aerobic activity. With the current data, it seems aerobic exercise interventions are more effective than those of stretching [14, 16, 22]. CVD and dementia are closely related—whether in the form of Alzheimer’s disease (AD) or CVD—and they share very similar risk factors [3, 23–25]. It’s possible that there are many mediation mechanisms that improve the CVDin relation to PA, by improving brain vascular function, cerebral perfusion, and the stimulation of synaptogenesis . Reinforcing data from recent years suggests that modifiable behavior can have an impact on brain plasticity in human beings and animals . Although unclear which mechanisms can influence the deposition of an amyloid, it is also possible that exercise can have direct relative effects on the metabolism of glucose and proteins through neurotrophic factors, neuroinflammatory factors, and cerebrovascular functioning . Therefore those interventions that are recommended to improve the CVD may be beneficial to improve the cognitive level, such as walking quickly on flat terrain, at least 30 minutes every day of the week [3, 23]. On the other hand, it is unclear why some cognitive functions seem to improve with physical exercise, while other functions seem to be insensitive to the change. This is an aspect that has been challenging to assess since there has been no agreement on the minimum battery of cognitive tests that must be carried out in order to detect clinically relevant and transparent changes, and that allow an increase in the reproducibility of the results in future investigations [12, 19, 21, 25].
Interventions with people with dementia and with their caregivers
One limitation of the effectiveness of NPT on PWD is the difficulty of carrying them out in the real environment where the PWD and caregivers are . Sometimes it is only possible to do so in specialized centers and almost always is a burden for the caregiver, aggravating the negative consequences that their own care entails, such as the deterioration of the mental health, poor social support and the decrease of leisure time . Of the interventions offered to CG of patients with dementia, the interventions are predominately psychosocial [2, 29]. One of the recommendations that should be done is to increase the time they have for themselves, since making pleasant activities is a proven method to improving one’s mood . It is therefore important to identify which activities you wish to participate in and to make a detailed list of the activities that can be increased, noting when they will take place. Pleasant activities are not only extraordinary activities like going on vacation to a far away place. They can actually be performed daily (reading the newspaper, knitting, talking with a friend on the phone, visiting friends, etc.). Additionally it is known that one of the disadvantages that the CG encounters when attempting to carry out rewarding activities is that it can be impossible to separate themselves from the patient while they are carrying out their duties . On the other hand, it has been observed that it is difficult for some caregivers to make the decision to carry out pleasant activities when these activities do not directly affect the improvement of the status of the family member whom they care for . A consequence of this is that the CG of PWD, when compared to non-caregivers, participate in less PA , show increased cardiovascular risk , have an increased risk of hypertension , and suffer more frequently from CVD [34, 35]. Although these problems can be associated with the state of chronic stress related to the care, and the difficulty in expressing emotions , there is no doubt that they are closely related to PA restriction [30, 37]. Von Kanel and col. have observed that caregivers, who reported high levels of PA, had a cardiovascular risk score similar to non-caregivers with the same level of PA . These results suggest that if they increase the levels of PA, the CG could decrease their cardiovascular risk to that of the non-caregivers. It is therefore necessary to evaluate the effectiveness of carrying out interventions that encourage PA for CG of PWD . In addition to assessing the degree PA of the caregivers, it seems necessary to develop interventions that specifically contribute to the increase of their PA. However, it is not easy to find interventions that have managed to increase the PA in adults, which thus would make it possible to reduce the high proportion of sedentary subjects that are in Spain. It is estimated to be 75% . At the community level, a Cochrane review in 2008 concluded that there is no sufficient data to support the hypothesis that the community interventions from the multiple components effectively increase the levels of PA of the population . Some RCTs developed in the field of Primary Health Care have achieved positive results, but this was only seen with the help of PA professionals or educators, and the family doctor. There was an increase of 9.7% in PA for the intervention group with the “green prescription” . Other results have had discrepancies between men and women , and if it appears to be effective in the increasing PA of the elderly . Within the framework of the European year 2012, the year of active aging and intergenerational solidarity, the HAPPIER study (Healthy Activity &Physical Programs Innovations in Elderly Residences) was initiated to be developed in elderly residences. However, there is more evidence that all patients with chronic illnesses should be refered to a rehabilitation program that includes an intervention of PA . Since chronic illness is stable, it seems reasonable that it should be managed in Primary Health Care and coordinated as a regular practice. The program has been initiated into the PACE-Lift in UK in order to determine the feasibility and effectiveness of a Primary Health Care intervention with a pedometer to increase PA among older patients . Our research program has participated in the project “Multi-center Evaluation of the Experimental Promotional Program of Physical Activity” (PEPAF) , from a sample of 5,000 subjects which were selected randomly from the population consultant in Primary Health Care of six Spanish provinces. The intervention was carried out in Primary Health Care centers and has been effective in increasing the level of PA among inactive patients . Controls for PA were increased to 18 minutes per week [95% 6–31 min/week]; with an increase of the METS/hour week of 1.3 [95% Cl, 0.4 2.2]. But what is most important in relation to this new project is that the effect of the intervention was particularly positive in people older than 50 years , therefore it could be appropriately applied to the PWD and their CG. On the other hand, in older adults there seems to be a linear relationship between the level of activity and health outcomes, not only among the sedentary, but also among those who walk more than 12,000 steps per day . Our study incorporates a particular perspective in respect to the gender differences, since more than 70% of the caregivers are women, these usually present a greater osteoarthritis, which makes them less possible to carry out PA .
Evaluation of the therapeutic interventions for dementia
There are many difficulties when assessing the effectiveness of the RCTs done on the PWD, both in general and for Alzheimer’s Disease. Therefore, both the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have developed several guides to oversee RCTs in patients with AD. It should be noted that in RCTs on Alzheimer’s Disease drugs the Evaluation Scale of Behavior-Cognitive Section (ADAS-cog) has been used almost unanimously as a measure of cognitive performance [18, 46]. It is a test that provides clinically significant information, which is well considered on a conceptual and neuropsychological basis . The use of the ADAS-cog as a fundamental measure of the cognitive state should be permitted to draw comparisons with the results from other NPT or even with the RCTs, taking all this into account as it has been proposed in recent trials [15, 18] and that is why this measure is proposed for our intervention. Due to the multidimensional nature of PA, there is no ideal way to measure PA since it occurs in natural contexts in a set of complex leisure and instrumental behaviors. These behaviors are conducted at different levels of intensity, duration, and with different frequencies, both within one day and in different seasons of the year. Also PA involves different parts of the body that make that the measure of PA is more effective in some circumstances than in others. The majority of research for evaluating PA has been mainly in adolescents. It is necessary to carry out research that can provide information about the difficulties of measuring PA in PWD. Self-report questionnaires are the most utilized methods for evaluating PA in research. The simultaneous involvement of the accompanying family member of the PWD during the walks, as well as the completion of a validated questionnaire (7-PAR), should provide important information on the possible relationship between the characteristics of PA and PWD. A very important drawback to evaluating PA in PWD based upon the tests carried out, is related to the large variability observed in terms of the dosage (intensity and duration), modality (aerobic, muscle endurance, etc.) and scope of preparation (at the home of the patient [13, 48], in residences or in hospital). In order to quantify the exercise dosage, it is important to use objective instruments to measure in this project, such as digital pedometers. On one hand it is important to know PA habits of the PWD and relatives, and on the other hand the effects of increasing their PA.
The objective of the first phase of this study is to evaluate the effectiveness of a Primary Health Care intervention to increase the PA of PWD and their relative caregivers and to keep the increase of PA for at least one year. The study will also evaluate if any effect is modified by age, gender, or participation as a pair. It will also be estimated the effect of the intervention on the patients in regards to their cognitive status, anthropometric measures, cardiovascular risk factors, overall health and quality of life.
There are studies that suggest that increasing PA in both PWD and CG seems to provide health benefits in both groups. However, there are no interventions that have demonstrated their effectiveness to ensure that both groups increase their PA.
Since the implementation of the project PEPAF in Primary Health Care it has been effective in increasing PA in inactive adults , especially among those over 50 years. We hope to demonstrate that a physical activity program that is adapted, designed, and applied by Primary Health Care professionals for patients with dementia and relative caregivers (predominantly women), is effective in increasing PA by 20% for PWD and their relative caregivers from Primary Health Care. Since the physical exercise seems to contribute and improve or slow down the cognitive impairment in PWD, we hope to reduce the ADAS-cog in PWD by 3 points. Since CVD and dementia are closely related—whether in the form of vascular cognitive impairment or in the form of Alzheimer’s Disease—and they share similar risk factors, if this program is effective, it may benefit people with dementia as well as relative caregivers, since it could help them maintain and improve their health, in particular the cognitive level of their patients and the cardiovascular problems of their CG which are derived from reduced physical activity due to the CG care tasks.