Personalized Integrated Care Promoting Quality of Life for Older People: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Alzheimer disease (AD) and Parkinson disease (PD) are the 2 most common neurodegenerative diseases affecting millions of people worldwide. The Personalized Integrated Care Promoting Quality of Life for Older People (PC4L) project proposes an integrated, scalable, and interactive care ecosystem that can be easily adapted to the needs of several neurodegenerative and chronic diseases, care institutions, and end user requirements. OBJECTIVE: The study protocol developed within the framework of the PC4L project aims to iteratively test the integrated platform and its modules, and focuses primarily on assessing the impact of the proposed solution (ie, the PC4L platform) on patients' quality of life, as well as its usability and feasibility on a large-scale sample size in 3 different scenarios (home, neurorehabilitation, and day care centers). METHODS: A prospective multicenter clinical study is conducted in 5 European countries (Germany, Italy, Portugal, Romania, and Spain) at 6 different pilot centers, for 3 months, in patients with PD, Parkinsonism, AD, and other dementias (ODs). Patients were randomized in a ratio of 1:1 to the intervention group (use of the PC4L system) or the control group (no intervention). The PC4L system consists mainly of a wristband for monitoring parameters such as steps and levels of physical activity, and the PC4L app, which includes different engaging functionalities. Both groups are assessed through baseline and end-of-study clinical evaluations, including assessment of quality of life through the EQ-5D-3L scale. RESULTS: The study protocol is part of a project approved and funded by the European Commission Horizon 2020 (grant agreement number 875221). The ethics committees of all involved centers reviewed and approved the study protocol. The study began with the recruitment phase in September 2022, and enrollment ended in February 2023. Recruitment is now closed (April 2023). The results of this study are expected to be published in summer 2023. A total of 558 patients, 279 per study group, were recruited. The results will allow to clarify the impact of PC4L on quality of life, will assess the empowerment of patients and the medical resources use, as well as the usability of the final version of the PC4L system. It will also provide information on the support of the system as a tool to facilitate the decision-making process. CONCLUSIONS: The PC4L project intends to test a technology-based, integrated, scalable, and interactive care platform on patients with neurodegenerative diseases and proposes a good coordinated care model between all involved actors. Future developments of the PC4L solution may involve caregivers and socio-health professionals in the decision-making process in order to facilitate efficient communication between all stakeholders and ensure reliable and protected access to data within Europe. TRIAL REGISTRATION: ClinicalTrials.gov NCT05538455; https://clinicaltrials.gov/study/NCT05538455. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47916.

Evidence-based yet still challenging! Research on physical activity in old age.

Preserving functional health and quality-of-life in old age is a major goal and global challenge in public health. The high rate of sedentary behavior that is characteristic of the older adult population exacerbates impairments of physiological and structural systems that are typically seen in the aging process. Achieving an understanding of the profound influence of physical activity on all aspects of health in old age is the driving force behind the emergence of "physical activity in old age" as a growing area of research. Accumulated evidence implies that being physically active and exercising is far superior to other optimal aging facilitators. Yet this area of research faces numerous constraints and obstacles. This commentary addresses some of these challenges, primarily the heterogeneity of the aging process, which induces both inter- and intra-individual differences among aged individuals, heterogeneity in assessment tools, unjustified inclusion/exclusion criteria and insufficient recruitment strategies, difficulties in implementing research results in real-world conditions, and rudimentary exploitation of innovative technology. We explain the importance of establishing a network of multidisciplinary scientists and stakeholders to propose consensus-based goals and scientifically evidenced wide-ranging plans for dealing with these challenges. In addition, we suggest work directions for this network.

PROCare4Life lessons learned.

PeRsOnalised Integrated CARE Solution for Elderly (PROCare4Life) was an EU-funded project that ran from January 2020 until June 2023, whose focus was to further develop and integrate previous ICT solutions developed by several previous EU-funded projects into a unique modular system able to support the autonomy and empowerment and to increase the Quality of Life (QoL) of elderly people living with Parkinson's, Alzheimer's, or similar dementia, having also tested the system for elderly people living with comorbidities. This article focuses on the methodology and results used to identify the internal lessons learned. PROCare4Life was developed using a codesign approach involving more than 2,000 participants whose input has been listened to and transformed into valuable changes of the system and also into lessons learned included in this case study report. Since the beginning of the implementation of PROCare4Life, there has been a commitment to make invisible knowledge visible through open discussion and including our lessons learned in each of our deliverables. In the last six months of implementation, qualitative research has been implemented by the PROCare4Life consortium to identify and select our most relevant challenges and recommendations for future projects and initiatives. PROCare4Life was highly impacted by the COVID-19 pandemic, and it is acknowledged in the lessons learned. However, the consortium has focused on the recommendations that could be more valuable for ordinary implementation of future projects and initiatives developing eHealth tools for elderly citizens living with conditions that might affect their cognitive or mobility capacities.

PeRsOnalised Integrated CARE Solution for Elderly (PROCare4Life) was an EU-funded project that ran from January 2020 until June 2023, aiming at improving the quality of life of older people living with Parkinson's, Alzheimer's or other dementia using ICT technologies. The term implementation refers to the process of putting a plan or idea into action. It is a complex process that involves multiple stages, including planning, execution, and evaluation. Implementation research is a growing field of health research that aims to study the factors that affect the implementation of health policies, programs, and practices. It can help identify the best strategies for introducing potential solutions into a health system or promoting their large-scale use and sustainability. For PROCare4Life, when using the term implementation it covers all the stages, including ideation and design phases, although focusing on the pilot 3 iterative codesign and testing of the system. Using daily life devices such as smartphones and smart watches, more than 2,000 people have contributed to co-creating PROCare4Life. The three profiles focused on were older people living with Parkinson's, Alzheimer's or other dementia, their main carers and their healthcare professionals, with an ICT system providing direct communication and allowing them to share their health status. Along the journey to develop PROCare4Life, our European consortium has learned many things that we have internally investigated and reported in this article. We have identified 20 challenges and 41 recommendations. We hope that our lessons learned might be inspiring and valuable for others, particularly future projects and initiatives developing eHealth tools for elderly EU citizens living with different conditions that might affect their cognitive or mobility capabilities.

End Users' and Other Stakeholders' Needs and Requirements in the Development of a Personalized Integrated Care Platform (PROCare4Life) for Older People With Dementia or Parkinson Disease: Mixed Methods Study.

BACKGROUND: With what has been known as the "triple-win effect", introducing information and communication technologies (ICTs) in the health care of neurodegenerative diseases is beneficial in delaying the need for institutional care, reducing the associated health care costs, reducing the caregiving burden, and improving individuals' quality of life. Nevertheless, the mismatch between the users' expectations and their actual needs remains one of the main challenges that can reduce the usability of technology solutions. Therefore, the European project Personalized Integrated Care Promoting Quality of Life for Older People (PROCare4Life), which aimed to develop an ICT-based platform for all parties involved in the health care of neurodegenerative diseases, adopted a user-centered design approach, where all users are involved from the inception and throughout the platform development and implementation to integrate their needs and requirements in the proposed platform. OBJECTIVE: This paper presents the results of a study on the needs and requirements of the potential end users (older people with neurodegenerative diseases, caregivers, and health care professionals) and other key stakeholders in the development of the PROCare4Life platform. METHODS: A mixed qualitative and quantitative study design was used, including 2 web-based surveys, 40 interviews, and 4 workshops. The study was conducted between April and September 2020 in 5 European countries: Germany, Italy, Portugal, Romania, and Spain. Both data types were analyzed separately and then merged and interpreted, with greater priority placed on qualitative research. RESULTS: A total of 217 participants were recruited; 157 (72.4%) of them completed the web-based surveys (n=85, 54.1% patients and n=72, 45.9% caregivers), and 60 (27.6%) individuals participated in the qualitative research (20/60, 33% health care professionals; 5/60, 8% patients; 5/60, 8% caregivers; and 30/60, 50% key stakeholders). We identified 3 main themes (T): (T1) experiences associated with illness, (T2) thoughts about the platform technology, and (T3) desired properties. Alerts for adverse events, communication tools, reminders, and monitoring are constantly needed functionalities, whereas ease of use, personalization, and user-friendliness are foreseen as necessary features. CONCLUSIONS: This paper identified the key personal, social, and health factors that influence the daily lives of the potential end users and reflected on their needs and expectations regarding the design of the proposed PROCare4Life platform. The collected data were useful for the development of the PROCare4Life platform. Although the combination and collection of features for diverse user groups are typical for integrated care platforms, it results in exponential complexity for designers, developers, and users. Contradicting opinions and several concerns in this study demonstrate that an ICT-integrated care platform should not promise too much for too many. Instead, selection, focus, and, sometimes, restriction to essentials are necessary. Users and other stakeholders should be involved in these decisions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/22463.

Using Motor Imagery to Access Alternative Attentional Strategies When Navigating Environmental Boundaries to Prevent Freezing of Gait - A Perspective.

Freezing of gait can cause reduced independence and quality of life for many with Parkinson's disease. Episodes frequently occur at points of transition such as navigating a doorway. Therapeutic interventions, i.e., drugs and exercise, do not always successfully mitigate episodes. There are several different, but not exclusive causes for freezing of gait. People with freezing of gait are able to navigate dynamic situations like stairways by utilizing a different attentional strategy to over-ground walking, but may freeze when passing through a doorway. The question is, is it possible to employ a special attentional strategy to prevent freezing at this point? Motor imagery allows for learning motor skills in absolute safety and has been widely employed in a variety of populations, including other neuro-compromised groups. Motor imagery is not studied in a homologous manner in people with Parkinson's Disease, leading to conflicting results, but may have the potential to establish a different attentional strategy which allows a subject to mitigate freezing of gait episodes. This paper will identify and discuss the questions that still need to be answered in order to consider this approach i.e., can this population access motor imagery, can motor imagery alter the attentional strategy employed when moving through doorways, what is the best motor imagery approach for people with Parkinson's Disease and freezing of gait, and what dosage is most effective, while briefly outlining future research considerations.

Globally altered sleep patterns and physical activity levels by confinement in 5056 individuals: ECLB COVID-19 international online survey.

Symptoms of psychological distress and disorder have been widely reported in people under quarantine during the COVID-19 pandemic; in addition to severe disruption of peoples' daily activity and sleep patterns. This study investigates the association between physical-activity levels and sleep patterns in quarantined individuals. An international Google online survey was launched in April 6th, 2020 for 12-weeks. Forty-one research organizations from Europe, North-Africa, Western-Asia, and the Americas promoted the survey through their networks to the general society, which was made available in 14 languages. The survey was presented in a differential format with questions related to responses "before" and "during" the confinement period. Participants responded to the Pittsburgh Sleep Quality Index (PSQI) questionnaire and the short form of the International Physical Activity Questionnaire. 5056 replies (59.4% female), from Europe (46.4%), Western-Asia (25.4%), America (14.8%) and North-Africa (13.3%) were analysed. The COVID-19 home confinement led to impaired sleep quality, as evidenced by the increase in the global PSQI score (4.37 ± 2.71 before home confinement vs. 5.32 ± 3.23 during home confinement) (p < 0.001). The frequency of individuals experiencing a good sleep decreased from 61% (n = 3063) before home confinement to 48% (n = 2405) during home confinement with highly active individuals experienced better sleep quality (p < 0.001) in both conditions. Time spent engaged in all physical-activity and the metabolic equivalent of task in each physical-activity category (i.e., vigorous, moderate, walking) decreased significantly during COVID-19 home confinement (p < 0.001). The number of hours of daily-sitting increased by ~2 hours/days during home confinement (p < 0.001). COVID-19 home confinement resulted in significantly negative alterations in sleep patterns and physical-activity levels. To maintain health during home confinement, physical-activity promotion and sleep hygiene education and support are strongly warranted.

Effects of home confinement on mental health and lifestyle behaviours during the COVID-19 outbreak: insights from the ECLB-COVID19 multicentre study.

Although recognised as effective measures to curb the spread of the COVID-19 outbreak, social distancing and self-isolation have been suggested to generate a burden throughout the population. To provide scientific data to help identify risk factors for the psychosocial strain during the COVID-19 outbreak, an international cross-disciplinary online survey was circulated in April 2020. This report outlines the mental, emotional and behavioural consequences of COVID-19 home confinement. The ECLB-COVID19 electronic survey was designed by a steering group of multidisciplinary scientists, following a structured review of the literature. The survey was uploaded and shared on the Google online survey platform and was promoted by thirty-five research organizations from Europe, North Africa, Western Asia and the Americas. Questions were presented in a differential format with questions related to responses "before" and "during" the confinement period. 1047 replies (54% women) from Western Asia (36%), North Africa (40%), Europe (21%) and other continents (3%) were analysed. The COVID-19 home confinement evoked a negative effect on mental wellbeing and emotional status (P < 0.001; 0.43 ≤ d ≤ 0.65) with a greater proportion of individuals experiencing psychosocial and emotional disorders (+10% to +16.5%). These psychosocial tolls were associated with unhealthy lifestyle behaviours with a greater proportion of individuals experiencing (i) physical (+15.2%) and social (+71.2%) inactivity, (ii) poor sleep quality (+12.8%), (iii) unhealthy diet behaviours (+10%), and (iv) unemployment (6%). Conversely, participants demonstrated a greater use (+15%) of technology during the confinement period. These findings elucidate the risk of psychosocial strain during the COVID-19 home confinement period and provide a clear remit for the urgent implementation of technology-based intervention to foster an Active and Healthy Confinement Lifestyle AHCL).

Sleep Quality and Physical Activity as Predictors of Mental Wellbeing Variance in Older Adults during COVID-19 Lockdown: ECLB COVID-19 International Online Survey.

BACKGROUND: The COVID-19 lockdown could engender disruption to lifestyle behaviors, thus impairing mental wellbeing in the general population. This study investigated whether sociodemographic variables, changes in physical activity, and sleep quality from pre- to during lockdown were predictors of change in mental wellbeing in quarantined older adults. METHODS: A 12-week international online survey was launched in 14 languages on 6 April 2020. Forty-one research institutions from Europe, Western-Asia, North-Africa, and the Americas, promoted the survey. The survey was presented in a differential format with questions related to responses "pre" and "during" the lockdown period. Participants responded to the Short Warwick-Edinburgh Mental Wellbeing Scale, the Pittsburgh Sleep Quality Index (PSQI) questionnaire, and the short form of the International Physical Activity Questionnaire. RESULTS: Replies from older adults (aged >55 years, n = 517), mainly from Europe (50.1%), Western-Asia (6.8%), America (30%), and North-Africa (9.3%) were analyzed. The COVID-19 lockdown led to significantly decreased mental wellbeing, sleep quality, and total physical activity energy expenditure levels (all p < 0.001). Regression analysis showed that the change in total PSQI score and total physical activity energy expenditure (F(2, 514) = 66.41 p < 0.001) were significant predictors of the decrease in mental wellbeing from pre- to during lockdown (p < 0.001, R2: 0.20). CONCLUSION: COVID-19 lockdown deleteriously affected physical activity and sleep patterns. Furthermore, change in the total PSQI score and total physical activity energy expenditure were significant predictors for the decrease in mental wellbeing.

Investigating Users' and Other Stakeholders' Needs in the Development of a Personalized Integrated Care Platform (PROCare4Life) for Older People with Dementia or Parkinson Disease: Protocol for a Mixed Methods Study.

BACKGROUND: Dementias-including Alzheimer disease-and Parkinson disease profoundly impact the quality of life of older population members and their families. PROCare4Life (Personalized Integrated Care Promoting Quality of Life for Older Adults) is a European project that recognizes the benefit of technology-based integrated care models in improving the care coordination and the quality of life of these target groups. This project proposes an integrated, scalable, and interactive care platform targeting older people suffering from neurodegenerative diseases, their caregivers, and socio-health professionals. PROCare4Life adopts a user-centered design approach from the early stage and throughout platform development and implementation, during which the platform is designed and adapted to the needs and requirements of all the involved users. OBJECTIVE: This paper presents the study protocol for investigating users' needs and requirements regarding the design of the proposed PROCare4Life platform. METHODS: A mixed qualitative and quantitative study design is utilized, including online surveys, interviews, and workshops. The study aimed to recruit approximately 200 participants, including patients diagnosed with dementia or Parkinson disease, caregivers, socio-health professionals, and other stakeholders, from five different European countries: Germany, Italy, Portugal, Romania, and Spain. RESULTS: The study took place between April and September 2020. Recruitment is now closed, and all the data have been collected and analyzed in order to be used in shaping the large-scale pilot phase of the PROCare4Life project. Results of the study are expected to be published in spring 2021. CONCLUSIONS: This paper charts the protocol for a user-centered design approach at the early stage of the PROCare4Life project in order to shape and influence an integrated health platform suitable for its intended target group and purpose. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/22463.

Psychological consequences of COVID-19 home confinement: The ECLB-COVID19 multicenter study.

BACKGROUND: Public health recommendations and government measures during the COVID-19 pandemic have enforced restrictions on daily-living. While these measures are imperative to abate the spreading of COVID-19, the impact of these restrictions on mental health and emotional wellbeing is undefined. Therefore, an international online survey (ECLB-COVID19) was launched on April 6, 2020 in seven languages to elucidate the impact of COVID-19 restrictions on mental health and emotional wellbeing. METHODS: The ECLB-COVID19 electronic survey was designed by a steering group of multidisciplinary scientists, following a structured review of the literature. The survey was uploaded and shared on the Google online-survey-platform and was promoted by thirty-five research organizations from Europe, North-Africa, Western-Asia and the Americas. All participants were asked for their mental wellbeing (SWEMWS) and depressive symptoms (SMFQ) with regard to "during" and "before" home confinement. RESULTS: Analysis was conducted on the first 1047 replies (54% women) from Asia (36%), Africa (40%), Europe (21%) and other (3%). The COVID-19 home confinement had a negative effect on both mental-wellbeing and on mood and feelings. Specifically, a significant decrease (p < .001 and Δ% = 9.4%) in total score of the SWEMWS questionnaire was noted. More individuals (+12.89%) reported a low mental wellbeing "during" compared to "before" home confinement. Furthermore, results from the mood and feelings questionnaire showed a significant increase by 44.9% (p < .001) in SMFQ total score with more people (+10%) showing depressive symptoms "during" compared to "before" home confinement. CONCLUSION: The ECLB-COVID19 survey revealed an increased psychosocial strain triggered by the home confinement. To mitigate this high risk of mental disorders and to foster an Active and Healthy Confinement Lifestyle (AHCL), a crisis-oriented interdisciplinary intervention is urgently needed.

Staying Physically Active During the Quarantine and Self-Isolation Period for Controlling and Mitigating the COVID-19 Pandemic: A Systematic Overview of the Literature.

The COVID-19 pandemic has created an unprecedented worldwide public health concern. Characterized by rapid and high frequency human-to-human transmission, the World Health Organization has recommended implementation of public health measures, including isolation of all suspected infectious individuals for a 14-day quarantine period, while governments have introduced "social distancing" and "lock-downs" of varying severity to curtail COVID-19 spread. Recent COVID-19 research further suggests there are major sleep problems and psychological disorders (e.g., stress, anxiety, depression) associated with the reduction of movement and activities, as well as the reduced social interaction. There have been no studies examining the effect of physical activity at home during such periods of isolation. However, based on previous research, potential tactics to overcome these negative effects include home-based exercise, exergaming, dancing to music, and participation in yoga. Adults should accumulate at least 150 min of moderate-intensity and at least 75 min of vigorous-intensity of activity divided in to 5-7 sessions per week. This training volume could be reduced by 30% for children and adolescents if replaced by recess or active play in and around the home. Additionally, exercises should be adapted to the fitness level of the participant and a progressive model of intensity and training volume should be utilized, preferably monitored by telephone applications and wearable sensors.

Practical Recommendations for Maintaining Active Lifestyle during the COVID-19 Pandemic: A Systematic Literature Review.

Diminished volumes of habitual physical activity and increased sedentary levels have been observed as a result of COVID-19 home-confinement. Consequences of inactivity, including a higher mortality rate and poorer general health and fitness, have been reported. This systematic review aimed to provide practical recommendations for maintaining active lifestyles during pandemics. In May 2020, two electronic databases (PubMed; Web of Science) were used to search for relevant studies. A total of 1206 records were screened by two researchers. Thirty-one relevant studies were included in this systematic review, in which the methodological quality was assessed. With regard to six studies, which explicitly dealt with physical activity during COVID-19, the evidence level is classified by three articles to level II, and in the other three to level VI. Regarding the physical activity recommendations in these papers, three of them were classified to a medium, and the same number to a weak evidence base. Of the 25 papers which refer to other pandemics and/or isolation situations, one was classified to evidence level I, four were ranged to level II, three to level III, one to level V, and the others to level VI. This systematic review revealed that reduced physical activity levels are of serious concern during home confinement in pandemic times. The recommendations provided by many international organizations to maintain active lifestyles during these times mainly target the general population, with less consideration for vulnerable populations (e.g., older adults, people with health issues). Therefore, personalized and supervised physical activity programs are urgently needed, with the option to group-play physical activity programs (e.g., exergames). These can be assisted, delivered, and disseminated worldwide through information and communication technology solutions. If it is permitted and safe, being active outside in daylight is advised, with an effort level of mild to moderate using the rating of perceived exertion scale. Relaxation techniques should be integrated into the daily routine to reduce stress levels. On the evidence base and levels of the included articles in this review, the results need to be interpreted with caution. Given that policies are different across regions and countries, further research is needed to categorize recommendations according to different social-distancing scenarios.

COVID-19 Home Confinement Negatively Impacts Social Participation and Life Satisfaction: A Worldwide Multicenter Study.

Public health recommendations and governmental measures during the new coronavirus disease (COVID-19) pandemic have enforced numerous restrictions on daily living including social distancing, isolation, and home confinement. While these measures are imperative to mitigate spreading of COVID-19, the impact of these restrictions on psychosocial health is undefined. Therefore, an international online survey was launched in April 2020 to elucidate the behavioral and lifestyle consequences of COVID-19 restrictions. This report presents the preliminary results from more than one thousand responders on social participation and life satisfaction. METHODS: Thirty-five research organizations from Europe, North-Africa, Western Asia, and the Americas promoted the survey through their networks to the general society, in 7 languages (English, German, French, Arabic, Spanish, Portuguese, and Slovenian). Questions were presented in a differential format with questions related to responses "before" and "during" confinement conditions. RESULTS: 1047 participations (54% women) from Asia (36%), Africa (40%), Europe (21%), and others (3%) were included in the analysis. Findings revealed psychosocial strain during the enforced COVID-19 home confinement. Large decreases (p < 0.001) in the amount of social activity through family (-58%), friends/neighbors (-44.9%), or entertainment (-46.7%) were triggered by the enforced confinement. These negative effects on social participation were also associated with lower life satisfaction (-30.5%) during the confinement period. Conversely, the social contact score through digital technologies significantly increased (p < 0.001) during the confinement period with more individuals (+24.8%) being socially connected through digital technology. CONCLUSION: These preliminary findings elucidate the risk of psychosocial strain during the early COVID-19 home confinement period in 2020. Therefore, in order to mitigate the negative psychosocial effects of home confinement, implementation of national strategies focused on promoting social inclusion through a technology-based solution is strongly suggested.

Effects of COVID-19 Home Confinement on Eating Behaviour and Physical Activity: Results of the ECLB-COVID19 International Online Survey.

BACKGROUND: Public health recommendations and governmental measures during the COVID-19 pandemic have resulted in numerous restrictions on daily living including social distancing, isolation and home confinement. While these measures are imperative to abate the spreading of COVID-19, the impact of these restrictions on health behaviours and lifestyles at home is undefined. Therefore, an international online survey was launched in April 2020, in seven languages, to elucidate the behavioural and lifestyle consequences of COVID-19 restrictions. This report presents the results from the first thousand responders on physical activity (PA) and nutrition behaviours. METHODS: Following a structured review of the literature, the "Effects of home Confinement on multiple Lifestyle Behaviours during the COVID-19 outbreak (ECLB-COVID19)" Electronic survey was designed by a steering group of multidisciplinary scientists and academics. The survey was uploaded and shared on the Google online survey platform. Thirty-five research organisations from Europe, North-Africa, Western Asia and the Americas promoted the survey in English, German, French, Arabic, Spanish, Portuguese and Slovenian languages. Questions were presented in a differential format, with questions related to responses "before" and "during" confinement conditions. RESULTS: 1047 replies (54% women) from Asia (36%), Africa (40%), Europe (21%) and other (3%) were included in the analysis. The COVID-19 home confinement had a negative effect on all PA intensity levels (vigorous, moderate, walking and overall). Additionally, daily sitting time increased from 5 to 8 h per day. Food consumption and meal patterns (the type of food, eating out of control, snacks between meals, number of main meals) were more unhealthy during confinement, with only alcohol binge drinking decreasing significantly. CONCLUSION: While isolation is a necessary measure to protect public health, results indicate that it alters physical activity and eating behaviours in a health compromising direction. A more detailed analysis of survey data will allow for a segregation of these responses in different age groups, countries and other subgroups, which will help develop interventions to mitigate the negative lifestyle behaviours that have manifested during the COVID-19 confinement.

Home-Based Exercise Supported by General Practitioner Practices: Ineffective in a Sample of Chronically Ill, Mobility-Limited Older Adults (the HOMEfit Randomized Controlled Trial).

OBJECTIVES: To evaluate the effects a home-based exercise program delivered to ill and mobility-limited elderly individuals on physical function, physical activity, quality of life, fall-related self-efficacy, and exercise self-efficacy. DESIGN: Randomized controlled trial (ISRCTN Registry, Reg.-No. ISRCTN17727272). SETTING: Fifteen general practitioner (GP) practices and participants' homes. PARTICIPANTS: Chronically ill and mobility-limited individuals aged 70 and older (N = 209). INTERVENTIONS: An exercise therapist delivered the experimental intervention-a 12-week multidimensional home-based exercise program integrating behavioral strategies-in individual counseling sessions at the GPs' practices and over the telephone. The control intervention focused on promoting light-intensity activities of daily living. Interventions took place between February 2012 and March 2013. MEASUREMENTS: The primary outcome was functional lower body strength (chair-rise test). Secondary outcomes were physical function (battery of motor tests), physical activity (step count), health-related quality of life (Medical Outcomes Study 8-item Short-Form Survey), fall-related (Falls Efficacy Scale-International Version), and exercise self-efficacy (Selbstwirksamkeit zur sportlichen Aktivitaet (SSA) scale). Postintervention differences between the groups were tested using analysis of covariance (intention to treat; adjusted for baseline value and GP practice; significance level P ≤ .05). RESULTS: Participants had a mean age ± standard deviation of 80 ± 5, 74% were female, 87% had three or more chronic diseases, and 54% used a walking aid. The difference (intention to treat; experimental minus control) between adjusted postintervention chair-rise times was -0.1 (95% confidence interval = -1.8-1.7). Differences for all secondary outcomes were also nonsignificant. CONCLUSION: The program was ineffective in the target population. Possibilities for improving the concept will have to be evaluated.

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices.

OBJECTIVES: To present detailed adverse event (AE) data from a randomized controlled trial (RCT) of a home-based exercise program delivered to an elderly high-risk population by an exercise therapist after medical clearance from a general practitioner (GP). DESIGN: Randomized controlled trial. SETTING: General practitioner practices and participant homes. PARTICIPANTS: Community-dwelling, chronically ill, mobility-limited individuals aged 70 and older (mean 80 ± 5) participating in a RCT of an exercise program (HOMEfit; ISRCTN17727272) (N = 209; n = 106 experimental, n = 103 control; 74% female). INTERVENTION: A 12-week multidimensional home-based exercise program (experimental) versus baseline physical activity counseling (control). An exercise therapist delivered both interventions to participants during counseling sessions at the GP's practice and on the telephone. MEASUREMENTS: Adverse events were documented at least at every counseling session and assessed by the GP and an AE manager. RESULTS: One hundred fifty-one AEs were reported in 47% (n = 99) of all participants. Twenty-one (14%) events were classified as serious. In six events (4%; n = 4 experimental, n = 2 control), participation in the study had to be discontinued immediately. In 25 events (17%; n = 9 experimental, n = 16 control), the intervention had to be suspended. The intervention was determined to have caused two events (both nonserious and in the experimental group). CONCLUSION: Even though the program appears to be safe, high morbidity unrelated to exercise can constitute a critical challenge for sustained exercise participation.

Recruiting hard-to-reach subjects for exercise interventions: a multi-centre and multi-stage approach targeting general practitioners and their community-dwelling and mobility-limited patients.

The general practitioner (GP)'s practice appears to be an ideal venue for recruiting community-dwelling older adults with limited mobility. This study (Current Controlled Trials ISRCTN17727272) aimed at evaluating the recruiting process used for a multi-centre exercise intervention (HOMEfit). Each of six steps resulted in an absolute number of patients (N1-N6). Sex and age (for N4-N6) and reasons for dropping out were assessed. Patient database screening (N1-N3) at 15 GP practices yielded N1 = 5,990 patients aged 70 and above who had visited their GP within the past 6 months, N2 = 5,467 after exclusion of institutionalised patients, N3 = 1,545 patients eligible. Using a pre-defined limitation algorithm in order to conserve the practices' resources resulted in N4 = 1,214 patients (80.3 ± 5.6 years, 68% female), who were then officially invited to the final assessment of eligibility at the GP's practice. N5 = 434 patients (79.5 ± 5.4 years, 69% female) attended the practice screening (n = 13 of whom had not received an official invitation). Finally, N6 = 209 (79.8 ± 5.2 years, 74% female) were randomised after they were judged eligible and had given their written informed consent to participate in the randomised controlled trial (overall recruitment rate: 4.4%). The general strategy of utilising a GP's practice to recruit the target group proved beneficial. The data and experiences presented here can help planners of future exercise-intervention studies.

The general practitioner's role in promoting physical activity to older adults: a review based on program theory.

Positive influences of physical activity both on many chronic diseases and on preservation of mobility are well documented. But chronically ill or mobility restricted elderly living in their own homes are difficult to reach for interventions. The general practitioner's (GP) surgery offers one of the few opportunities to give advice for physical activity to those people. We used program theory to sound out knowledge on GP-centered physical activity counseling. The "conceptual theory" (evidence for training effects in old age) and the "implementation theory" (unique position of the GP) were reviewed narratively. The "action theory" (effects of GP counseling) was reviewed systematically. According to program theory, appropriate MeSH (Medical subject headings) concepts were Aged OR Aged, 80 and over (Target group), Physicians, Family OR Primary Health Care (Implementation/Setting), Counseling OR Patient Education as Topic OR Disease Management OR Health promotion (Intervention), Exercise OR Motor Activity OR Physical Fitness OR Sports (Determinants). The resulting six review papers (Pubmed, 2000-2009) were presented using the STARLITE mnemonic. Authors agree, that the GP plays a central role in the promotion of physical activity to elderly people, but there is conflicting evidence concerning counseling effectiveness. Utilizing behavioral change strategies and the collaboration between GPs and specialised professions are recommended and currently under research.

Effects of an exercise programme for chronically ill and mobility-restricted elderly with structured support by the general practitioner's practice (HOMEfit) - study protocol of a randomised controlled trial.

BACKGROUND: Exercise programmes can be administered successfully as therapeutic agents to patients with a number of chronic diseases and help to improve physical functioning in older adults. Usually, such programmes target either healthy and mobile community-dwelling seniors or elderly individuals living in nursing institutions or special residences. Chronically ill or mobility-restricted individuals, however, are difficult to reach when they live in their own homes.A pilot study has shown good feasibility of a home-based exercise programme that is delivered to this target group through cooperation between general practitioners and exercise therapists. A logical next step involves evaluation of the effects of the programme. METHODS/DESIGN: The study is designed as a randomised controlled trial. We plan to recruit 210 patients (≥ 70 years) in about 15 general practices.The experimental intervention (duration 12 weeks)-a multidimensional home-based exercise programme-is delivered to the participant by an exercise therapist in counselling sessions at the general practitioner's practice and on the telephone. It is based on methods and strategies for facilitating behaviour change according to the Health Action Process Approach (HAPA). The control intervention-baseline physical activities-differs from the experimental intervention with regard to content of the counselling sessions as well as to content and frequency of the promoted activities.Primary outcome is functional lower body strength measured by the "chair-rise" test. Secondary outcomes are: physical function (battery of motor tests), physical activity (step count), health-related quality of life (SF-8), fall-related self-efficacy (FES-I), and exercise self-efficacy (SSA-Scale).The hypothesis that there will be differences between the two groups (experimental/control) with respect to post-interventional chair-rise time will be tested using an ANCOVA with chair-rise time at baseline, treatment group, and study centre effects as explanatory variables. Analysis of the data will be undertaken using the principle of intention-to-treat. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17727272.