Outcome domains measured in randomized controlled trials of physical activity for older adults: a rapid review.

BACKGROUND: Toward development of a core outcome set for randomized controlled trials (RCTs) of physical activity (PA) interventions for older adults, the purpose of this study was to identify outcome domains and subdomains ('what' was measured) in previously published RCTs of PA for older adults. METHODS: We conducted a rapid review and searched Ovid MEDLINE for recently- published (2015-2021), English-language, RCTs of PA interventions for older adults (mean age 60+ yrs). We limited to articles published in Web of Science top-10 journals in general and internal medicine, geriatrics and gerontology, rehabilitation, and sports science. Two reviewers independently completed eligibility screening; two other reviewers abstracted trial descriptors and study outcomes. We classified study outcomes according to the standard outcome classification taxonomy endorsed by the Core Outcome Measures in Effectiveness Trials Initiative. RESULTS: Our search yielded 548 articles; 67 articles were eligible to be included. Of these, 82% were efficacy/effectiveness trials, 85% included both male and female participants, and 84% recruited community-dwelling older adults. Forty percent of articles reported on interventions that involved a combination of group and individual PAs, and 60% involved a combination of PA modes (e.g., aerobic, resistance). Trial sample size ranged from 14 to 2157 participants, with median (IQR) of 94 (57-517); 28,649 participants were included across all trials. We identified 21 unique outcome domains, spanning 4/5 possible core areas (physiological/clinical; life impact; resource use; adverse events). The five most commonly reported outcome domains were physical functioning (included in n=51 articles), musculoskeletal and connective tissue (n=30), general (n=26), cognitive functioning (n=16), and emotional functioning/wellbeing (n=14). Under these five outcome domains, we further identified 10 unique outcome subdomains (e.g., fall-related; body composition; quality of life). No outcome domains or subdomains were reported consistently in all RCTs. CONCLUSIONS: We found extensive variability in outcome domains and subdomains used in RCTs of PA for older adults, reflecting the broad range of potential health benefits derived from PA and also investigator interest to monitor a range of safety parameters related to adverse events. This study will inform development of a core outcome set to improve outcome reporting consistency and evidence quality.

Feasibility of a Virtual Health-Promoting Intervention (Choose to Move) for Older Adults: A Rapid Adaptation in Response to COVID-19.

To support older adults during the first wave of COVID-19, we rapidly adapted our effective health-promoting intervention (Choose to Move [CTM]) for virtual delivery in British Columbia, Canada. The intervention was delivered (April-October 2020) to 33 groups of older adults ("programs") who were a convenience sample (had previously completed CTM in person; n = 153; 86% female; 73 [6] years). We compared implementation outcomes (recruitment, dose received, retention, and completion of virtual data collection) to predetermined feasibility targets. We assessed mobility, physical activity, and social health outcomes pre- and postintervention (3 months) with validated surveys. We met most (dose received, retention, and virtual data collection), but not all (recruitment), feasibility targets. Approximately two thirds of older adults maintained or improved mobility, physical activity, and social health outcomes at 3 months. It was feasible to implement and evaluate CTM virtually. In future, virtual CTM could help us reach homebound older adults and/or serve as support during public health emergencies.

Rapidly adapting an effective health promoting intervention for older adults-choose to move-for virtual delivery during the COVID-19 pandemic.

BACKGROUND: The COVID-19 (COVID) pandemic shifted way of life for all Canadians. 'Stay-at-home' public health directives counter transmission of COVID but may cause, or exacerbate, older adults' physical and social health challenges. To counter unintentional consequences of these directives, we rapidly adapted an effective health promoting intervention for older adults-Choose to Move (CTM)-to be delivered virtually throughout British Columbia (BC). Our specific objectives were to 1. describe factors that influence whether implementation of CTM virtually was acceptable, and feasible to deliver, and 2. assess whether virtual delivery retained fidelity to CTM's core components. METHODS: We conducted a 3-month rapid adaptation feasibility study to evaluate the implementation of CTM, virtually. Our evaluation targeted two levels of implementation within a larger socioeconomic continuum: 1. the prevention delivery system, and 2. older adult participants. We implemented 33 programs via Zoom during BC's 1st wave acute and transition stages of COVID (April-October 2020). We conducted semi-structured 30-45 min telephone focus groups with 9 activity coaches (who delivered CTM), and semi-structured 30-45 min telephone interviews with 30 older adult participants, at 0- and 3-months. We used deductive framework analysis for all qualitative data to identify themes. RESULTS: Activity coaches and older adults identified three key factors that influenced acceptability (a safe and supportive space to socially connect, the technological gateway, and the role of the central support unit) and two key factors that influenced feasibility (a virtual challenge worth taking on and CTM flexibility) of delivering CTM virtually. Activity coaches also reported adapting CTM during implementation; adaptations comprised two broad categories (time allocation and physical activity levels). CONCLUSION: It was feasible and acceptable to deliver CTM virtually. Programs such as CTM have potential to mitigate the unintended consequences of public health orders during COVID associated with reduced physical activity, social isolation, and loneliness. Adaptation and implementation strategies must be informed by community delivery partners and older adults themselves. Pragmatic, virtual health promoting interventions that can be adapted as contexts rapidly shift may forevermore be an essential part of our changing world.

Physical activity is good for older adults-but is programme implementation being overlooked? A systematic review of intervention studies that reported frameworks or measures of implementation.

OBJECTIVE: To examine older adult physical activity (PA) intervention studies that evaluated implementation and/or scale-up. Research question 1: What implementation and/or scale-up indicators (specific, observable and measurable characteristics that show the progress of implementation) were reported? Research question 2: What implementation and/or scale-up frameworks were reported? Research question 3: Did studies evaluate the relationship between implementation or scale-up of the intervention and individual level health/behaviour outcomes? If yes, how? DESIGN: Systematic review. DATA SOURCES: Publications from electronic databases and hand searches (2000 to December 2019). ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Any PA intervention studies with community-dwelling older adult participants (mean age ≥60 years). Required indicators: (a) Must report amount of PA as an outcome, with validated self-report or objective measures, and (b) Must have reported at least one implementation or scale-up framework and/or one implementation or scale-up indicator. RESULTS: 137 studies were included for research question 1, 11 for question 2 and 22 for question 3. 137 studies reported an implementation indicator: 14 unique indicators. None were specified as indicators for scale-up evaluation. 11 studies were guided by an implementation or scale-up framework. 22 studies described a relationship between an implementation indicator and an individual-level health outcome. CONCLUSION: There is need for implementation research that extends beyond analysis at the individual level, includes clearly defined indicators and provides a guiding framework to support PA initiatives in older adults. Such implementation studies should evaluate factors in the broader context (eg,political, environmental) that influence scale-up. PROSPERO REGISTRATION: CRD42018091839.

Getting Ready for Scale-Up of an Effective Older Adult Physical Activity Program: Characterizing the Adaptation Process.

To optimize public health impact, health interventions must be delivered widely to reach the population in need. Yet, few interventions are ever implemented at broad scale (scaled-up). Thus it is necessary to devise implementation strategies that support scale-up of effective interventions. Adapting an intervention and implementation strategies to the local context to improve "fit" at scale-up is critical to success. Therefore, our study responds to a call to build a database of systematic adaptations of evidence-based interventions across populations and contexts, including scaled-up designs. To do so, we focus on the process of adapting an effective physical activity program for older adults, called Choose to Move (CTM), for scale-up. Our objectives were to describe the systematic process of adapting CTM for scale-up across British Columbia (BC) and to report the actual changes made to CTM. We adopted a 6-step process: (1) identify stakeholders; (2) conduct needs assessment; (3) develop prototype of adaptations; (4) validate prototype with stakeholders; (5) create adapted program; and (6) pilot test adaptations. For the adaptation process, we described each step and organized data within an adaptation coding system. Results showed that adaptations to CTM span program content, program context, and the training modules. For example, to address the request by CTM participants for more opportunities to socially connect with others, we added more group meetings, reduced phone check-ins, and integrated aspects of training related to social cohesion. Our study extends the current literature by providing researchers a clear pathway toward adapting health promotion interventions for scale-up.

Implementation and scale-up of physical activity and behavioural nutrition interventions: an evaluation roadmap.

BACKGROUND: Interventions that work must be effectively delivered at scale to achieve population level benefits. Researchers must choose among a vast array of implementation frameworks (> 60) that guide design and evaluation of implementation and scale-up processes. Therefore, we sought to recommend conceptual frameworks that can be used to design, inform, and evaluate implementation of physical activity (PA) and nutrition interventions at different stages of the program life cycle. We also sought to recommend a minimum data set of implementation outcome and determinant variables (indicators) as well as measures and tools deemed most relevant for PA and nutrition researchers. METHODS: We adopted a five-round modified Delphi methodology. For rounds 1, 2, and 3 we administered online surveys to PA and nutrition implementation scientists to generate a rank order list of most commonly used; i) implementation and scale-up frameworks, ii) implementation indicators, and iii) implementation and scale-up measures and tools. Measures and tools were excluded after round 2 as input from participants was very limited. For rounds 4 and 5, we conducted two in-person meetings with an expert group to create a shortlist of implementation and scale-up frameworks, identify a minimum data set of indicators and to discuss application and relevance of frameworks and indicators to the field of PA and nutrition. RESULTS: The two most commonly referenced implementation frameworks were the Framework for Effective Implementation and the Consolidated Framework for Implementation Research. We provide the 25 most highly ranked implementation indicators reported by those who participated in rounds 1-3 of the survey. From these, the expert group created a recommended minimum data set of implementation determinants (n = 10) and implementation outcomes (n = 5) and reconciled differences in commonly used terms and definitions. CONCLUSIONS: Researchers are confronted with myriad options when conducting implementation and scale-up evaluations. Thus, we identified and prioritized a list of frameworks and a minimum data set of indicators that have potential to improve the quality and consistency of evaluating implementation and scale-up of PA and nutrition interventions. Advancing our science is predicated upon increased efforts to develop a common 'language' and adaptable measures and tools.

Factors that influence implementation at scale of a community-based health promotion intervention for older adults.

BACKGROUND: Despite the many known benefits of physical activity (PA), relatively few older adults are active on a regular basis. Older adult PA interventions delivered in controlled settings showed promising results. However, to achieve population level health impact, programs must be effectively scaled-up, and few interventions have achieved this. To effectively scale-up it is essential to identify contextual factors that facilitate or impede implementation at scale. Our aim is to describe factors that influence implementation at scale of a health promotion intervention for older adults (Choose to Move). This implementation evaluation complements our previously published study that assessed the impact of Choose to Move on older adult health indicators. METHODS: To describe factors that influenced implementation our evaluation targeted five distinct levels across a socioecological continuum. Four members of our project team conducted semi-structured interviews by telephone with 1) leaders of delivery partner organizations (n = 13) 2) recreation managers (n = 6), recreation coordinators (n = 27), activity coaches (n = 36) and participants (n = 42) [August 2015 - April 2017]. Interviews were audio-recorded and professionally transcribed and data were analyzed using framework analysis. RESULTS: Partners agreed on the timeliness and need for scaled-up evidence-based health promotion programs for older adults. Choose to Move aligned with organizational priorities, visions and strategic directions and was deemed easy to deliver, flexible and adaptable. Partners also noted the critical role played by our project team as the support unit. However, partners noted availability of financial resources as a potential barrier to sustainability. CONCLUSIONS: Even relatively simple evidence-based interventions can be challenging to scale-up and sustain. To ensure successful implementation it is essential to align with multilevel socioecological perspectives and assess the vast array of contextual factors that are at the core of better understanding successful implementation.

Implementation of a co-designed physical activity program for older adults: positive impact when delivered at scale.

BACKGROUND: Despite known health benefits of physical activity (PA), older adults remain among the least physically active age group globally with 30-60% not meeting guidelines. In Canada, 87% do not meet recommended guidelines. To influence population health, interventions that are effective in small trials must be disseminated at scale. Despite evidence for efficacy, few PA interventions are scaled up to reach the wider community. In 2015, British Columbia (BC) Ministry of Health released a PA strategy where older adults were identified as a priority. In partnership with the Ministry, the Active Aging Research Team co-created a health promotion program called Choose to Move (CTM). CTM will be implemented in three phases at increasingly greater scale across BC. The objective of this study is to evaluate the effectiveness of CTM during Phase I (pilot) and Phase II (initial scale up) on PA, mobility, and social connectedness among older adults in BC, Canada. METHODS: We used a type 2 hybrid effectiveness-implementation study design, and herein focus on effectiveness. The implementation evaluation will be published as a companion paper elsewhere. Two community delivery partner organizations delivered 56 CTM programs in 26 large and small urban locations across BC. Outcome measurement occurred at 0 (baseline), 3 (mid-intervention) and 6 (post-intervention) months. We collected survey data from all participants (n = 458; province-wide) and also conducted a subset evaluation (n = 209). RESULTS: PA increased significantly during the active intervention phase (baseline-3 months) in younger (60-74 yrs.; + 1.6 days/week; p < 0.001) and older (≥75 yrs.; + 1.0 days/week; p < 0.001) participants. The increase was sustained at 6 months in younger participants only, who remained significantly more active than at baseline (+ 1.4 days/week; p < 0.001). Social exclusion indicators declined significantly in the younger group. Mobility and strength improved significantly at 3 months in the younger group, and in both groups at 6 months. CONCLUSIONS: CTM adopted central tenets of implementation science that consider the complicated systems where interventions are delivered to improve public health. In this iteration of CTM we demonstrate that a partner-based health promotion intervention can be effectively implemented across settings to enhance PA, mobility and social connectedness in older adults.

"Life Goes On." Everyday Tasks, Coping Self-Efficacy, and Independence: Exploring Older Adults' Recovery From Hip Fracture.

Older adults face many challenges in the first few months after hip fracture. Rehabilitation holds promise to assist the recovery process. Therefore, we used semistructured interviews to explore older adults' and allied health professionals' acceptance of a rehabilitation intervention for hip fracture, and we described perceptions of the early recovery period (<4 months). Interviews were recorded and transcribed verbatim; three authors independently read the transcripts multiple times and together developed themes guided by Interpretive Description. Older adults described the intervention as acceptable and provided valuable feedback for its future implementation. Older adults also provided reflections on their experience of fracture recovery. Themes that emerged included physical limitations and loss of independence, the long recovery time, and coping with additional complications of living with multimorbidity. To overcome challenges, older adults identified the need for social support and physical activity, balanced by their own personal outlook.

Understanding Physical Activity Motivation and Behavior Through Self-Determination and Servant Leadership Theories in a Feasibility Study.

Despite its well-established benefits, physical activity engagement is low in the adult population; evidence suggests that this is especially a concern for women >60 years. The purpose of this mixed methods study was to explore the feasibility of a 6-week randomized control trial of self-determination theory-based dance and walking programs for older women. Primary outcomes were feasibility measures: recruitment, retention, and satisfaction. Secondary outcomes included self-reported physical activity, behavioral regulations, and psychological needs. Thirty-five women completed the study (M = 62.8 ± 4.8 years), representing 39% recruitment and 95% retention rate. Both programs were highly attended. Exploratory effect sizes for secondary measures were promising. Emergent themes highlighted the importance of servant leadership concepts in the group setting for motivating physical activity. Our findings provide support for expanding this trial to a full-scale study.

An educational video to promote multi-factorial approaches for fall and injury prevention in long-term care facilities.

BACKGROUND: Older adults living in long term care (LTC) settings are vulnerable to fall-related injuries. There is a need to develop and implement evidence-based approaches to address fall injury prevention in LTC. Knowledge translation (KT) interventions to support the uptake of evidence-based approaches to fall injury prevention in LTC need to be responsive to the learning needs of LTC staff and use mediums, such as videos, that are accessible and easy-to-use. This article describes the development of two unique educational videos to promote fall injury prevention in long-term care (LTC) settings. These videos are unique from other fall prevention videos in that they include video footage of real life falls captured in the LTC setting. METHODS: Two educational videos were developed (2012-2013) to support the uptake of findings from a study exploring the causes of falls based on video footage captured in LTC facilities. The videos were developed by: (1) conducting learning needs assessment in LTC settings via six focus groups (2) liaising with LTC settings to identify learning priorities through unstructured conversations; and (3) aligning the content with principles of adult learning theory. RESULTS: The videos included footage of falls, interviews with older adults and fall injury prevention experts. The videos present evidence-based fall injury prevention recommendations aligned to the needs of LTC staff and: (1) highlight recommendations deemed by LTC staff as most urgent (learner-centered learning); (2) highlight negative impacts of falls on older adults (encourage meaning-making); and, (3) prompt LTC staff to reflect on fall injury prevention practices (encourage critical reflection). CONCLUSIONS: Educational videos are an important tool available to researchers seeking to translate evidence-based recommendations into LTC settings. Additional research is needed to determine their impact on practice.

Visual hindsight bias for abnormal mammograms in radiologists.

Purpose: Hindsight bias-where people falsely believe they can accurately predict something once they know about it-is a pervasive decision-making phenomenon, including in the interpretation of radiological images. Evidence suggests it is not only a decision-making phenomenon but also a visual perception one, where prior information about an image enhances our visual perception of the contents of that image. The current experiment investigates to what extent expert radiologists perceive mammograms with visual abnormalities differently when they know what the abnormality is (a visual hindsight bias), above and beyond being biased at a decision level. Approach: N=40 experienced mammography readers were presented with a series of unilateral abnormal mammograms. After each case, they were asked to rate their confidence on a 6-point scale that ranged from confident mass to confident calcification. We used the random image structure evolution method, where the images repeated in an unpredictable order and with varied noise, to ensure any biases were visual, not cognitive. Results: Radiologists who first saw an original image with no noise were more accurate in the max noise level condition [area under the curve (AUC)=0.60] than those who first saw the degraded images (AUC=0.55; difference: p=0.005), suggesting that radiologists' visual perception of medical images is enhanced by prior visual experience with the abnormality. Conclusions: Overall, these results provide evidence that expert radiologists experience not only decision level but also visual hindsight bias, and have potential implications for negligence lawsuits.

What is the 'voltage drop' when an effective health promoting intervention for older adults-Choose to Move (Phase 3)-Is implemented at broad scale?

BACKGROUND: Choose to Move (CTM), an effective health-promoting intervention for older adults, was scaled-up across British Columbia, Canada. Adaptations that enable implementation at scale may lead to 'voltage drop'-diminished positive effects of the intervention. For CTM Phase 3 we assessed: i. implementation; ii. impact on physical activity, mobility, social isolation, loneliness and health-related quality of life (impact outcomes); iii. whether intervention effects were maintained; iv) voltage drop, compared with previous CTM phases. METHODS: We conducted a type 2 hybrid effectiveness-implementation pre-post study of CTM; older adult participants (n = 1012; mean age 72.9, SD = 6.3 years; 80.6% female) were recruited by community delivery partners. We assessed CTM implementation indicators and impact outcomes via survey at 0 (baseline), 3 (mid-intervention), 6 (end-intervention) and 18 (12-month follow-up) months. We fitted mixed-effects models to describe change in impact outcomes in younger (60-74 years) and older (≥ 75 years) participants. We quantified voltage drop as percent of effect size (change from baseline to 3- and 6-months) retained in Phase 3 compared with Phases 1-2. RESULTS: Adaptation did not compromise fidelity of CTM Phase 3 as program components were delivered as intended. PA increased during the first 3 months in younger (+1 days/week) and older (+0.9 days/week) participants (p<0.001), and was maintained at 6- and 18-months. In all participants, social isolation and loneliness decreased during the intervention, but increased during follow-up. Mobility improved during the intervention in younger participants only. Health-related quality of life according to EQ-5D-5L score did not change significantly in younger or older participants. However, EQ-5D-5L visual analog scale score increased during the intervention in younger participants (p<0.001), and this increase was maintained during follow-up. Across all outcomes, the median difference in effect size, or voltage drop, between Phase 3 and Phases 1-2 was 52.6%. However, declines in social isolation were almost two times greater in Phase 3, compared with Phases 1-2. CONCLUSION: Benefits of health-promoting interventions-like CTM-can be retained when implemented at broad scale. Diminished social isolation in Phase 3 reflects how CTM was adapted to enhance opportunities for older adults to socially connect. Thus, although intervention effects may be reduced at scale-up, voltage drop is not inevitable.

Experimental manipulation of affective judgments about physical activity: a systematic review and meta-analysis of adults.

The purpose of this meta-analysis was to examine the current effectiveness of physical activity (PA) interventions to change affective judgements (AJ) and subsequent behaviour and explore potential moderators. Eligible studies were published in a peer-reviewed English journal and included an experimental design in the PA domain with a measure of AJ as the dependent variable, among adults (>17 years). Literature searches concluded in July 2017 using 11 common databases, with additional hand searching conducted in February 2018. The search yielded 32 independent studies. Random-effects meta-analysis showed positive changes in AJ favouring intervention over control groups, g = 0.43 (95% CI = 0.26-0.60). These changes predicted (ß = 0.64) positive changes in PA, g = 0.38 (95% CI = 0.16-0.60), among a sub-sample (k = 14) of studies that also provided behavioural data. Moderator analyses showed the effects were inflated by potential publication bias, participant gender, baseline PA and focus of the intervention. AJ may show change from intervention but larger sample studies are required to obtain a more reliable effect size estimate. Further, few studies have employed behaviour change techniques that would align with the theoretical reasons for changes in AJ, so our evidence for practical intervention content is limited.

Can a Lifestyle Intervention Increase Active Transportation in Women Aged 55-70 years? Secondary Outcomes From a Pilot Randomized Controlled Trial.

BACKGROUND: Physical activity confers many health benefits to older adults, and adopting activity into daily life routines may lead to better uptake. The purpose of this study was to test the effect of a lifestyle intervention to increase daily physical activity in older women through utilitarian walking and use of public transportation. METHODS: In total, 25 inactive women with mean age (SD) of 64.1 (4.6) years participated in this pilot randomized controlled trial [intervention (n = 13) and control (n = 12)]. Seven-day travel diaries (trips per week) and the International Physical Activity Questionnaire (minutes per week) were collected at baseline, 3, and 6 months. RESULTS: At 3 months, intervention participants reported 9 walking trips per week and 643.5 minutes per week of active transportation, whereas control participants reported 4 walking trips per week and 49.5 minutes per week of active transportation. Adjusting for baseline values, there were significant group differences favoring Everyday Activity Supports You for walking trips per week [4.6 (0.5 to 9.4); P = .04] and active transportation minutes per week [692.2 (36.1 to 1323.5); P = .05]. At 6 months, significant group differences were observed in walking trips per week [6.1 (1.9 to 11.4); P = .03] favoring the intervention (9 vs 2 trips per week). CONCLUSION: Given these promising findings, the next step is to test Everyday Activity Supports You model's effectiveness to promote physical activity in older women within a larger study.