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20Towards better evidence-informed physical activity interventions for loneliness: lessons learnt from implementation and delivery of physical activity intervention for loneliness (pail) in older adults
UDC 796.034
H
PhD A.V. Shvedko1
1Pirogov Russian National Medical University, the Russian Clinical Research Center of Gerontology, Moscow, Russian Federation
Corresponding author: [email protected]
Abstract
Study objective. The aim of this study was to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults at risk of loneliness.
Methods and structure of the study. Study design was a 12-week randomised controlled feasibility trial (RCT). Participants were 25 (mean age 68.5(8.05) years, range 60-92) healthy, inactive, community-dwelling older adults at risk for loneliness. The intervention consisted of group outdoor walking sessions with health education workshops once weekly, with a wait-list control condition. Estimation of recruitment, retention and adherence were feasibility outcomes. Body mass index, blood pressure, physical activity, and psychosocial variables were secondary outcomes.
Results and conclusions. Forty-eight participants were recruited over 4 months with a recruitment rate of 52.1% (25/48); 52% (25/48) met the inclusion criteria and 100% (25/25) were randomised into the intervention (N=12) and wait-listed (WL) control groups (N=13). At 12 weeks, 10/12 (83.3%; 95% CI 55.20 to 95.30) intervention and 10/13 (76.9%; 95% CI 49.74 to 91.82) control participants completed final assessments. The average attendance rate was 69.2% for the intervention group (range 25% - 91.7%) and 55% (range 25% - 91.7%) among controls. The a priori recruitment criteria for progression was not met. The retention rate satisfied the criteria of the study. No serious adverse events occurred. Community-dwelling older adults at risk of loneliness can safely participate in physical activity intervention for loneliness. However, change in design and methodology would be required to progress into a large-scale RCT.
Keywords: physical activity, older adults, loneliness, feasibility study.
Background. The value of maintaining social connections through the lifespan is important for mental health and well-being of older adults [14]. Due to health decline, older adults may be prone to home-based regime and have long periods of inactivity. This can exacerbate the feeling of loneliness. Consequences of perceived or lifelong loneliness or social isolation are having detrimental effects on mental health and well-being and impact health-related quality of life, with the last having a number of outcome measurements [13]. According to statistics, one-third of older adults are feeling loneliness at least sometimes and 5% of older adults report feeling loneliness often [27]. Severe loneliness is reported less
and was found below 15% in older adults in different studies [25]. Research suggests that loneliness is closely linked to the increased morbidity and mortality [7] and its negative effect on health is comparable to smoking fitness cigarettes a day [25]. The precise link of low social relationships and mortality in adults is not well understood, however, it is likely to be mediated through physical activity, diet and behavior [25] and contribute to healthy ageing [11]. On psychological level, loneliness is linked to stress and depression [7]. On the physiological level, loneliness may lead to increased inflammation in older adults (Tull et al., 2020). In reverse, social support may correspond to better immune functioning and decrease inflamma-
tion [29]. The negative health effect of loneliness is the greatest in older adults with chronic health conditions, from low social-economic background, having lower education level and those living in poorest regions [41]. Research shows that physical activity can be effective for loneliness reduction in older adults to improve psychological well-being and general health [53]. Also, social relationships correspond to promoting decreased length of hospitalisation [31] linking social promotion interventions to inform public health and clinical practice in accordance with the strategy for tackling loneliness in England [24]. In this regard, the focus of health specialists was at loneliness prevention strategies for older adults as a high-risk population group [4]. Physical activity allows decreasing sedentary activity, maintaining physical and social health and reduce the risk frailty [28], and was shown to be an effective compensatory strategy in previous research [43, 49]. General population with strong social skills are 50% less predisposed to early mortality from all-cause risk factors compared to peers with low social relations [25, p.14]. However, there is a need for developing evidence-based interventions to prevent loneliness and social isolation in older adults in programmes of physical activity. Moreover, there is a need to implement health promotion behavioural strategies to promote health behavior and overcome barriers to exercise participation [41]. In addition, there is a need for improvement of exercise adherence, which is likely to decrease over time in older population [50].
To meet the sufficient level of PA older adults must meet minimum PA recommendations. The Centers for Disease Control and Prevention has published updated Physical Activity recommendations for older adults aged 65 years and over (Physical Activity Guidelines, PAG) in November 2018 [9]. According to the recommendations, older adults should accumulate a minimum of 150 minutes of moderate intensity physical activity (MPA) weekly (2 hours and 30 minutes) performed in any bouts [1]. In addition, increase of a minimum physical activity (PA) up to 300 minutes a week without any specific contraindications is associated with better health effect [1]. For those who are already active 75 minutes of vigorous PA (VPA) or combination of moderate-to-vigorous PA (MVPA) can results in extra health benefits [1]. Additionally older adults should perform 3 times/week and 2 times/week strengthening and balancing activities respectively [34]. In this updated PA guidelines the 10-minute bout was removed and the importance of even light intensity activity was highlighted for reducing morbidity and mortality [9]. Reducing the sedentary activity (or any long bouts of inactivity) contributes to reduced risk of developing heart diseases, high blood pressure, and all-cause mortality [1]. For those not meeting the current minimum PA recommendations, greater benefits
can be achieved by reducing sedentary behavior, increasing moderate-intensity physical activity, or combinations of both [1].
Systematic evidence suggests that there is a lack of available evidence regarding effects of PA on loneliness reduction particularly in community-dwelling older adults and any existing evidence is sparse [41]. Majority of existing studies are not accounting for publication bias, and do not take into account participant characteristics (e.g. age, gender, ethnicity, health condition) and differences between structural (social networks, social integration, marital status, living alone) and functional (received social support, perceptions of social support) or multifaceted assessment of social characteristics, or study characteristics (e.g. geographical location, length of follow-up). All of which can moderate relationships between PA and loneliness [25]. As a result, the interpretation of obtained data with a high heterogeneity observed in systematic studies can be partially due to unexplained variations in individual health characteristics and not to the effect of health intervention itself which was also consistent with previous research [41]. The features of effective interventions, obtained from the systematic review [41], were used to design and implement the novel feasibility randomised controlled study entitled "A Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults" [42]. Aims of the study were to estimate:
1. Recruitment rate, attendance and retention rates (number of participants completing the study as a proportion of those randomised).
2. The acceptability of the intervention by participants, and willingness to participate.
3. The appropriateness of the statistical methods of data analysis used.
4. The required sample size for a future large-scale RCT derived from a power calculation.
5. The acceptability of measures, and the most suitable primary outcome measure for a future large-scale RCT.
Methods/design. This intervention included 12 weeks of outdoor group walking and healthy workshops once weekly [42]. Walking was chosen because it is the most feasible and cost-effective method of physical activity for older adults. Written informed consent was obtained from all participants prior to entry into the study. After randomisation, participants in the intervention group started the 12-week intervention. Participants in the WL control (delayed intervention) group started the intervention after their follow-up measures were completed, approximately 12 weeks post-randomisation.
Loneliness was assessed using the 8-item UCLA Loneliness Scale (UCLA-8) [22]. Social support was assessed using the 20-item Medical Outcomes Study
Social Support Survey (MOSSSS) [39]. Social networks were categorised using the 6-item Lubben's Social Network Scale (LSNS-6) [32]. Depression and anxiety were assessed using the 14-item Hospital Anxiety and Depression Scale (HADS) [54]. Self-efficacy for exercise was measured using the revised 9-item Self-Efficacy for Walking/Exercise Scale (SEE), using a paper-and-pencil format [36]. Satisfaction with level of social contacts (SSC) was measured with the question "How satisfied are you with your social contacts?" [15]. Expected outcomes and barriers for exercise were measured using the Expected Outcomes and Barriers for Habitual Exercise scale [46] adapted for the older adult population. Four questions related to sport competence were deleted from the expected outcomes sub-scale due to irrelevance for this population group [46].
The progression criteria to a definitive large-scale RCT were: 1) no any serious adverse events, such as hospitalisation, life-threatening condition, death and any adverse events associated with the intervention experienced by less than 5% of participants per group; 2) recruitment rate of no less than 75% by the end of the four months recruitment period; and 3) retention rate of no less than 75% in each group at 12 weeks (end-point). If all three criteria were not met, there would be insufficient evidence to justify proceeding to the definitive RCT No targets were set for other feasibility outcomes, e.g., questionnaire completion rates or attendance at the intervention sessions.
Results and discussion. Participants were 25 (mean (SD) 68.5(8.05) years, range 60-92 years) healthy, inactive, community-dwelling older adults, 14 (56%) female, and 18 (72%) white.
Feasibility outcomes
The recruitment rate was 25% (48/195). The average attendance rate for the total of 12 sessions of the walking intervention was 58.3% for the intervention group, with attendance ranging from 33.0% to 75.0%. The average attendance rate for the wait-list control group was 42.3%, with attendance ranging from 23.1% to 69.2 %.
Secondary outcomes
There were no significant differences between the intervention and control groups at baseline in all measures except for number (n) of sit-to-stand transitions (p=0.02), which were 14.4 points lower in the intervention group (mean 43.3(11.3)) compared with controls (mean 57.6(15.8); 95% CI 2.91, 25.81). A mixed repeated between-within subjects' ANOVA showed that there were no significant between (group) or within (time) interaction effects during the study for all outcomes (Table 1).
Recommendations for future research
Findings of this trial suggest that community-dwelling older adults at risk of loneliness found the in-
tervention and measures acceptable and could safely participate. However, a more extensive and robust strategy would be needed to support adequate recruitment of lonely older adults and adherence into a definitive RCT. Based on the progression criteria, the retention rate was satisfactory, e.g. >75% of participants at 12 weeks (end-point period). The recruitment rate of 25% by the end of the four months was somewhat lower than initially proposed at 75%. No adverse events were found. Therefore, only two out of three criteria of progression to the definitive RCT were satisfied, meaning that the study was not feasible to deliver in its present form and needs modifications. Moreover, there is a need to promote older adults' change in PA behavior as one of the health strategy to overcome inactivity linked to mortality. This article will address some limitations that were raised in PAIL study as well as discuss how this intervention can be improved in the future trial.
Attendance
One of the reasons for low adherence obtained in PAIL study [40] can be due to impaired self-regulation, which was found to be typical for lonely individuals in previous research and affected PA intervention participation [42]. Also, self-esteem and self-worth are likely to induce positive affective responses in PA interventions which was not determined in the PAIL study. Therefore, the improvement of adherence to the future intervention should be discussed based on the existing evidence. The PAIL feasibility study had a mixed-method approach utilising qualitative methods (e.g. focus group interviews) which were aimed to gather participants' feedback on the intervention, including the reasons for participation, and any suggestions for improvement. The results showed that older adults experience barriers for participation, such as transport difficulties getting to and from the location of walks and healthy workshops, seasonal preferences of summer-autumn season versus winter-spring time. Other preferences were related to a certain time and day of the intervention with preference given to at least 10 am and weekday versus weekends [40]. Focus group interviews were conducted only for participants of experimental group, therefore, future study may conduct interviews for control group participants firstly, to understand their experiences in completing assessment forms, regarding research methods, design of the intervention and other feedback. Also, as follows from focus group interviews with older adults [40] providing transport and food to PA intervention for loneliness may significantly increase adherence and reduce drop outs [45].
Promotion of PA behavior
One of the way to promote PA behavior can be the implementation of digital behavior change techniques (BCTs) such as the use of mobile apps and devices
for tracking amount of PA. In face-to-face interventions most effective were self-regulatory BCTs (e.g. goal settings (behavior), self-monitoring of behavior) [20]. Other effective techniques for promotion of PA interventions with older adults were as follows: feedback on progress, reviewing of behavior goals, engaging social support, follow-up prompts, and use of relapse management techniques [20]. Additional benefits were gained by increasing number of visits to participants by a nurse or by skateholders (who were activity leaders of local community clubs) [20]. Among effective BCTs in digital behavior change interventions (DBCIs) were self-efficacy, intention and action planning which can be effective to promote PA participation among older adults and can be acceptable in this population [47]. The systematic review of Stockwell et al (2019) demonstrated up to 52 min/per week increase in MVPA (N=22) (SMD=0.47; 95% CI 0.32, 0.62, p < 0.001; MD=52 min/week) and up to 58 minutes a day decrease in sedentary time (SMD=-0.45; 95%CI -0.69, -0.19; p < 0.001; MD=58 min/day) in web-based PA interventions for older adults. Average number of reported BCTs was 6.6 (range 2-23; median=5.5) [47]. Similarly, the systematic review of Greaves et al (2011) showed increased physical activity (30-60 mins/week of moderate activity at 12-18 months) using behavior change techniques (BCTs) (N=30) [20]. The use of step-goals or a step diary along with activity tracker increased walking behavior on about 54 minutes per week in the study of Greaves et al., 2011 [20]. Therefore, the evidence does not support the use of digital devices (e.g. activity trackers) without behavior change techniques. Not many studies assess barriers to physical activity and explore the association between motivation for physical activity and exercise behavior. Therefore, additionally intervention mapping can be implemented to identify process of change of PA behavior, as well as recommended to use for identification of any barriers and strategies of supporting behavior and overcoming these barriers [20]. Use of peer-volunteering support and increased number of contacts with the staff can be beneficial to overcome barriers and promote health behavior [20]. To provide focus on maintenance, self-monitoring of progress and providing a feedback were widely implemented in PA promotion interventions with older adults [44].
Inclusion of theoretical frameworks
One of the limitation of existing intervention studies is the absence of any theoretical frameworks [42]. However, only theory-driven interventions can explain the mechanism of social-cognitive predictors that change a health behavior and promote PA in older adults. Most effective theoretical frameworks in PA health promotion interventions for older adults obtained in the literature were socio-ecological model
(i.e., individual, community, (i.e., individual, relationship, community, and societal levels) [3,9], health promotion programme [52], transtheoretical model [48], stages of change and I-Change model [5], and social-cognitive theory [2]. They are typically assessed using questionnaires at pre-to-post periods. In accordance with the social-cognitive theory [2] self-efficacy, intention and action planning mediated the change of PA behavior in older adults in the 10-week online PA interventions with the same intervention plus activity tracker in the study of Ratz et al. (2020) [35]. Based on the socio-ecological model there are interactions between all levels and variation between causal factors and preventions at each level can be measured as, for instance, using example of the loneliness framework [30]. All of the said above suggest that effectivity of loneliness reduction PA interventions for older adults can be increased by implementing one of above behavioural change strategies for promoting and increasing PA.
Recruitment difficulties
Another problem is a community-based recruitment of older adults at risk of loneliness into PA interventions, which is a challenge of health-care providers [26,40]. Identifying and recruiting older adults into loneliness reduction PA interventions is difficult due to lack of transparency in assessment of loneliness and the relative lack of it's precise definitions [41]. Such methods of recruiting as mass-media advertisement and the use of flyers and leaflets are common for research interventions due to limited resources available [40], however they are biased to particular category of participants who are willing to participate and leaving those who are most at risk not covered. Also, mass advertisements is less effective than recruitment though general practitioner (GP) which is used in minority of studies and requiring more time associated with ethical approval and resources for the study [26]. Other beneficial methods of recruitment of older adults at risk of loneliness can be referrals by recognised agencies, used either alone or together with other methods of recruitment. Previous research with older adults showed effects of a personalised invitation card in the envelope delivered to the door, use of local social community clubs for advertising intervention, a word-of-mouth and by contacting the activity leaders of community organisations [26]. Participants can also be recruited through local commercial mailing list of residents depending on the sources available for the study. In addition to self-report standardised loneliness tools to recruit participants based on loneliness, such as the UCLA Loneliness Scale [38] and the de Jong Gierveld Loneliness Scale [17], assessment of other risk factors must be assessed to include those at high risk [4]. Among factors associated with loneliness in pre-
vious research were such as poor health condition, independent living, perceived loneliness (widowhood or loss of a close friend), relocation and change in socio-cultural environment, low education level, ethnicity and other factors that often stay neglected. Victor et al (2020) for instance, used a combination of a self-report assessment of loneliness using the 3 item UCLA with a score of 6 and over for defining loneliness (from 3 = not lonely to 9 = lonely) and a question about how often people felt lonely in their area of residence (area-based; ranging from 1 = often to 7 = never, using cut off 4+ to define loneliness).
Control group condition
The wait-list control (WLC) group condition was used in the PAIL feasibility study, which is likely to generate a nocebo effect (a worsening symptom of disappointment, e.g., anxiety, worsening psychological well-being) as opposed to no treatment control group or placebo condition [16]. Those potential participants who are promised to receive an intervention later may remain inactive and not seek for further solutions to the health problem as promised the delayed intervention. This can result in worsening of depression symptoms and further impair their psychosocial well-being [16]. This WLC condition may also induce a certain frustration associated with waiting for the promised intervention and increase feelings of despair and uncertainty and, therefore, overestimate the effect size estimate [19]. On the contrary, in 'no treatment' condition approach participants who was not promised any intervention and asked not to change their lifestyle will remain motivated to seek for advice for activity in the future [16]. Also, there is a likelihood of a high drop-out rate in participants assigned to WLC condition. However, for feasibility studies the amount of time and resources can be significantly saved using the WLC condition approach. Therefore, the future study may utilise control (sedentary) group condition to account for the limitations associated with WLC design in the large-scale RCT. In addition, the limitations associated with ethical reasons of not receiving the promised interventions in no treatment control group should also be discussed.
Health education classes
Group health education classes conducted only for lonely individuals may increase "the tendency of negativity" of lonely individuals [23, p.571]. Lonely people often lack essential social skills to develop relationships with strangers and were shown to have unrealistic friendship expectations. With this intervention programmes designed to form social relationships in lonely people in specially created experimental setting (such as health education classes) may not always work. This is coincident with the results of qualitative
analysis conducted in PAIL intervention [40] where participants expressed opinion to use less formal approach to health education classes and conduct them not in the class environment (preferable outdoor) and to be free from obligatory attendance (e.g. as an invitation to attend the health education classes in the free time). Therefore, inclusion of health education classes should be added as extra activity for older adults who wish to listen to the topics of their choice and freely communicate with others to share their opinions. The format of round tables can be applied instead of the structured small group conversation with a leader being a moderator of discussions between participants.
Conclusions
The existing effects of loneliness reduction PA interventions older adults both obtained from the systematic review and the feasibility trial evidence need to be improved in order to proceed to the large-scale trial. Improvements must be implemented in the research design that can be strengthened by inclusion of a theory-based approach to the stages of change and health-promotion strategies of PA, as well as the content and delivery on the walking-based intervention. These major alterations suggested above may be plausible and implementation of the feasibility study with further adaptation to the community-dwelling older adult population may result in better effect on psychosocial outcomes. Bearing in mind that psychosocial environment can have a significant effect on health behavior of older adults and their physical health, delivery of such intervention can significantly advance the existing knowledge for health and clinical professionals in healthy ageing area. Future studies should incorporate a robust methodology and contribute to the consequent high quality randomised controlled study to generate the evidence-based knowledge.
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