Effect of a coaching intervention to enhance physical activity and prevent falls in community-dwelling people aged 60+ years: a cluster randomised controlled trial.

OBJECTIVES: To evaluate the effect of a coaching intervention compared with control on physical activity and falls rate at 12 months in community-dwelling people aged 60+ years. DESIGN: Cluster randomised controlled trial. SETTING: Community-dwelling older people. PARTICIPANTS: 72 clusters (605 participants): 37 clusters (290 participants) randomised to the intervention and 35 (315 participants) to control. INTERVENTION: Intervention group received written information, fall risk assessment and prevention advice by a physiotherapist, activity tracker and telephone-based coaching from a physiotherapist focused on safe physical activity. Control group received written information and telephone-based dietary coaching. Both groups received up to 19 sessions of telephone coaching over 12 months. OUTCOMES: The co-primary outcomes were device-measured physical activity expressed in counts per minute at 12 months and falls rate over 12 months. Secondary outcomes included the proportion of fallers, device-measured daily steps and moderate-to-vigorous physical activity (MVPA), self-reported hours per week of physical activity, body mass index, eating habits, goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being and disability. RESULTS: The mean age of participants was 74 (SD 8) years, and 70% (n=425) were women. There was no significant effect of the intervention on device-measured physical activity counts per minute (mean difference 5 counts/min/day, 95% CI -21 to 31), or falls at 12 months (0.71 falls/person/year in intervention group and 0.87 falls/person/year in control group; incidence rate ratio 0.86, 95% CI 0.65 to 1.14). The intervention had a positive significant effect on device-measured daily steps and MVPA, and self-reported hours per week of walking, well-being, quality of life, and disability. No significant between-group differences were identified in other secondary outcomes. CONCLUSION: A physical activity and fall prevention programme including fall risk assessment and prevention advice, plus telephone-based health coaching, did not lead to significant differences in physical activity counts per minute or falls rate at 12 months. However, this programme improved other physical activity measures (ie, daily steps, MVPA, hours per week of walking), overall well-being, quality of life and disability. TRIAL REGISTRATION NUMBER: ACTRN12615001190594.

Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial.

BACKGROUND: There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide. METHODS: A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically. DISCUSSION: This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ( ANZCTR ) Registration date: 10/12/2018.

"Sharing Success with Someone": Building therapeutic alliance in physiotherapist-delivered physical activity coaching for healthy aging.

INTRODUCTION: Therapeutic alliance, a goal-orientated partnership between clients and practitioners, can enhance program engagement and adherence, and improve treatment outcomes and satisfaction. OBJECTIVES: To develop an empirical model that describes how therapeutic alliances can be operationalized in clinical and research settings and use this in our evaluation of the Coaching for Healthy Ageing (CHAnGE) trial. METHODS: Secondary analysis of interviews with participants in the CHAnGE trial (n = 32) and a focus group with the physiotherapists who delivered health coaching in that trial (n = 3). Analysis was inductive (thematic) and deductive (using a therapeutic alliance model derived from a literature review and informed by earlier analyses). RESULTS: Data from participants and physiotherapists indicated that health coaching in CHAnGE built effective therapeutic alliances (i.e. it facilitated collaborative decision-making and trusting person-centered relationships) which were underpinned by professional skills and structural supports. Components of the intervention that strengthened therapeutic alliance were health coaching training, home visits, the coaching format, and provision of free activity monitors. CONCLUSION: This study identifies key concepts and practical 'building blocks' of therapeutic alliance, showing how these were operationalized within an intervention. This may help those in clinical and research settings to recognize the importance and characteristics of therapeutic alliance and put it into practice.

Using self-determination theory to understand and improve recruitment for the Coaching for Healthy Ageing (CHAnGE) trial.

BACKGROUND: Intervention trials promoting physical activity among older people frequently report low and unrepresentative recruitment. Better understanding of reasons for participation can help improve recruitment. This study explored why participants enrolled in the Coaching for Healthy Ageing (CHAnGE) trial, including how their decision was influenced by recruitment strategies. CHAnGE was a cluster randomised controlled trial testing the effectiveness of a healthy ageing program targeting inactivity and falls. Seventy-two groups of people aged 60+ were recruited from community organisations via informal presentations by the health coaches. METHODS: We conducted a secondary thematic analysis of interview data from our wider qualitative evaluation in which 32 purposively sampled trial participants took part in semi-structured interviews about their experiences of CHAnGE. Data relating to recruitment and participation were analysed inductively to identify themes, then a coding framework comprising the core constructs from self-determination theory-autonomy, competence and relatedness-was used to explore if and how this theory fit with and helped to explain our data. RESULTS: Recruitment presentations promoted the CHAnGE intervention well in terms of addressing value expectations of structured support, different forms of accountability, credibility, achievability and, for some, a potential to enhance social relationships. Participation was motivated by the desire for improved health and decelerated ageing, altruism and curiosity. These factors related strongly to self-determination concepts of autonomy, competence and relatedness, but the intervention's demonstrated potential to support self-determination needs could be conveyed more effectively. CONCLUSIONS: Findings suggest that recruitment could have greater reach using: 1. Strengths-based messaging focusing on holistic gains, 2. Participant stories that highlight positive experiences, and 3. Peer support and information sharing to leverage altruism and curiosity. These theory-informed improvements will be used to increase participation in future trials, including people in hard-to-recruit groups. They may also inform other physical activity trials and community programs.

Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial.

INTRODUCTION: Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists. METHODS AND ANALYSIS: This pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the StepWatch Activity Monitor over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other. ETHICS AND DISSEMINATION: Ethical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers. TRIAL REGISTRATION NUMBER: ACTRN12618001983291.

Exercise to Reduce Mobility Disability and Prevent Falls After Fall-Related Leg or Pelvic Fracture: RESTORE Randomized Controlled Trial.

BACKGROUND: Disability and falls are common following fall-related lower limb and pelvic fractures. OBJECTIVE: To evaluate the impact of an exercise self-management intervention on mobility-related disability and falls after lower limb or pelvic fracture. DESIGN: Randomized controlled trial. PARTICIPANTS: Three hundred thirty-six community dwellers aged 60+ years within 2 years of lower limb or pelvic fracture recruited from hospitals and community advertising. INTERVENTIONS: RESTORE (Recovery Exercises and STepping On afteR fracturE) intervention (individualized, physiotherapist-prescribed home program of weight-bearing balance and strength exercises, fall prevention advice) versus usual care. MAIN MEASURES: Primary outcomes were mobility-related disability and rate of falls. KEY RESULTS: Primary outcomes were available for 80% of randomized participants. There were no significant between-group differences in mobility-related disability at 12 months measured by (a) Short Physical Performance Battery (continuous version, baseline-adjusted between-group difference 0.08, 95% CI - 0.01 to 0.17, p = 0.08, n = 273); (b) Activity Measure Post Acute Care score (0.18, 95% CI - 2.89 to 3.26, p = 0.91, n = 270); (c) Late Life Disability Instrument (1.37, 95% CI - 2.56 to 5.32, p = 0.49, n = 273); or in rate of falls over the 12-month study period (incidence rate ratio 0.96, 95% CI 0.69 to 1.34, n = 336, p = 0.83). Between-group differences favoring the intervention group were evident in some secondary outcomes: balance and mobility, fall risk (Physiological Profile Assessment tool), physical activity, mood, health and community outings, but these should be interpreted with caution due to risk of chance findings from multiple analyses. CONCLUSIONS: No statistically significant intervention impacts on mobility-related disability and falls were detected, but benefits were seen for secondary measures of balance and mobility, fall risk, physical activity, mood, health, and community outings. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12610000805077.

A combined physical activity and fall prevention intervention improved mobility-related goal attainment but not physical activity in older adults: a randomised trial.

QUESTIONS: In people aged ≥ 60 years, does a combined physical activity and fall prevention intervention affect physical activity and mobility-related goal attainment? Does the combined intervention also improve fall rates, daily steps, the proportion of people meeting the physical activity guidelines, quality of life, mood, fear of falling, and mobility limitation? DESIGN: Randomised trial with concealed allocation, intention-to-treat analysis and assessor blinding. PARTICIPANTS: One hundred and thirty-one people living in the community and aged ≥ 60 years. INTERVENTIONS: The experimental group received one physiotherapist visit, fortnightly telephone-based health coaching, a pedometer, tailored fall prevention advice, and a fall prevention brochure. The control group received the same fall prevention brochure. OUTCOME MEASURES: Primary outcomes were mobility goal attainment (Goal Attainment Scale) and objectively measured physical activity (accelerometer counts per minute) at 6 and 12 months. Secondary outcomes were falls, other physical activity measures, quality of life, fear of falling, mood, and mobility. RESULTS: Participants had a mean age of 71 years (SD 6.5) and 31 (24%) had fallen in the past year. The experimental group reported significantly better mobility goal attainment at 6 months compared to controls (OR 2.0, 95% CI 1.1 to 3.7) but this was not maintained at 12 months (OR 1.1, 95% CI 0.6 to 2.1). Physical activity counts were not significantly different between groups at 6 months (MD 13 counts/minute, 95% CI -98 to 124) or 12 months (MD 56 counts/minute, 95% CI -14 to 125). There were no significant between-group differences in the secondary outcomes. CONCLUSION: A combined physical activity and fall prevention intervention was associated with significantly higher mobility goal attainment at 6 months. There was no significant impact on physical activity but future investigation in a larger trial is warranted. TRIAL REGISTRATION: ACTRN12614000016639.

Factors Associated With the Setting of Health-Related Goals Among Community-Dwelling Older People.

This study aimed to summarize the function-related goals set by older people, and to explore gender differences in goal selection and associations between balance-related goals and fall history, self-rated balance, and fear of falling. We included community-dwelling people aged 60 years and older participating in two randomized controlled trials. Participants nominated two function-related goals, which were summarized into components of the International Classification of Functioning, Disability and Health. Chi-square analyses were used to explore associations between goal types and participant characteristics. Goals related to recreation and leisure and walking were the most common function-related goals selected. Men and women set similar goals. Participants who had poor/fair self-reported balance were more likely to set a balance-related goal than people with good self-rated balance. In contrast, fallers and participants who had a fear of falling were not more likely to select a balance-related goal than nonfallers and participants who had no fear of falling, respectively.

Exercise and fall prevention self-management to reduce mobility-related disability and falls after fall-related lower limb fracture in older people: protocol for the RESTORE (Recovery Exercises and STepping On afteR fracturE) randomised controlled trial.

BACKGROUND: Lasting disability and further falls are common and costly problems in older people following fall-related lower limb and pelvic fractures. Exercise interventions can improve mobility after fracture and reduce falls in older people, however the optimal approach to rehabilitation after fall-related lower limb and pelvic fracture is unclear. This randomised controlled trial aims to evaluate the effects of an exercise and fall prevention self-management intervention on mobility-related disability and falls in older people following fall-related lower limb or pelvic fracture. Cost-effectiveness of the intervention will also be investigated. METHODS/DESIGN: A randomised controlled trial with concealed allocation, assessor blinding for physical performance tests and intention-to-treat analysis will be conducted. Three hundred and fifty people aged 60 years and over with a fall-related lower limb or pelvic fracture, who are living at home or in a low care residential aged care facility and have completed active rehabilitation, will be recruited. Participants will be randomised to receive a 12-month intervention or usual care. The intervention group will receive ten home visits from a physiotherapist to prescribe an individualised exercise program with motivational interviewing, plus fall prevention education through individualised advice from the physiotherapist or attendance at the group based "Stepping On" program (seven two-hour group sessions). Participants will be followed for a 12-month period. Primary outcome measures will be mobility-related disability and falls. Secondary outcomes will include measures of balance and mobility, falls risk, physical activity, walking aid use, frailty, pain, nutrition, falls efficacy, mood, positive and negative affect, quality of life, assistance required, hospital readmission, and health-system and community-service contact. DISCUSSION: This study will determine the effect and cost-effectiveness of this exercise self management intervention on mobility-related disability and falls in older people who have recently sustained a fall-related lower limb or pelvic fracture. The results will have implications for the design and implementation of interventions for older people with fall related lower limb fractures. The findings of this study will be disseminated in peer-reviewed journals and through professional and scientific conferences. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12610000805077.

What is the effect of a combined physical activity and fall prevention intervention enhanced with health coaching and pedometers on older adults' physical activity levels and mobility-related goals? Study protocol for a randomised controlled trial.

BACKGROUND: Physical inactivity and falls in older people are important public health problems. Health conditions that could be ameliorated with physical activity are particularly common in older people. One in three people aged 65 years and over fall at least once annually, often resulting in significant injuries and ongoing disability. These problems need to be urgently addressed as the population proportion of older people is rapidly rising. This trial aims to establish the impact of a combined physical activity and fall prevention intervention compared to an advice brochure on objectively measured physical activity participation and mobility-related goal attainment among people aged 60+. METHODS/DESIGN: A randomised controlled trial involving 130 consenting community-dwelling older people will be conducted. Participants will be individually randomised to a control group (n = 65) and receive a fall prevention brochure, or to an intervention group (n = 65) and receive the brochure plus physical activity promotion and fall prevention intervention enhanced with health coaching and a pedometer. Primary outcomes will be objectively measured physical activity and mobility-related goal attainment, measured at both six and 12 months post randomisation. Secondary outcomes will include: falls, the proportion of people meeting the physical activity guidelines, quality of life, fear of falling, mood, and mobility limitation. Barriers and enablers to physical activity participation will be measured 6 months after randomisation. General linear models will be used to assess the effect of group allocation on the continuously-scored primary and secondary outcome measures, after adjusting for baseline scores. Between-group differences in goal attainment (primary outcome) will be analysed with ordinal regression. The number of falls per person-year will be analysed using negative binomial regression models to estimate the between-group difference in fall rates after one year (secondary outcome). Modified Poisson regression models will compare groups on dichotomous outcome measures. Analyses will be pre-planned, conducted while masked to group allocation and will use an intention-to-treat approach. DISCUSSION: This trial will address a key gap in evidence regarding physical activity and fall prevention for older people and will evaluate a program that could be directly implemented within Australian health services. TRIAL REGISTRATION: ACTRN12614000016639, 7/01/2014.

Validity of the Fitbit activity tracker for measuring steps in community-dwelling older adults.

BACKGROUND: Commercially available activity monitors, such as the Fitbit, may encourage physical activity. However, the accuracy of the Fitbit in older adults remains unknown. This study aimed to determine (1) the criterion validity of Fitbit step counts compared to visual count and ActiGraph accelerometer step counts and (2) the accuracy of ActiGraph step counts compared to visual count in community-dwelling older people. METHODS: Thirty-two community-dwelling adults aged over 60 wore Fitbit and ActiGraph devices simultaneously during a 2 min walk test (2MWT) and then during waking hours over a 7-day period. A physiotherapist counted the steps taken during the 2MWT. RESULTS: There was excellent agreement between Fitbit and visually counted steps (intraclass correlation coefficient (ICC2,1)=0.88, 95% CI 0.76 to 0.94) from the 2MWT, and good agreement between Fitbit and ActiGraph (ICC2,1=0.66, 95% CI 0.41 to 0.82), and between ActiGraph and visually counted steps (ICC2,1=0.60, 95% CI 0.33 to 0.79). There was excellent agreement between the Fitbit and ActiGraph in average steps/day over 7 days (ICC2,1=0.94, 95% CI 0.88 to 0.97). Percentage agreement was closest for Fitbit steps compared to visual count (mean 0%, SD 4%) and least for Fitbit average steps/day compared to the ActiGraph (mean 13%, SD 25%). CONCLUSIONS: The Fitbit accurately tracked steps during the 2MWT, but the ActiGraph appeared to underestimate steps. There was strong agreement between Fitbit and ActiGraph counted steps. The Fitbit tracker is sufficiently accurate to be used among community-dwelling older adults to monitor and give feedback on step counts.

Exercise to enhance mobility and prevent falls after stroke: the community stroke club randomized trial.

BACKGROUND: Exercise interventions can enhance mobility after stroke as well as prevent falls in elderly persons. OBJECTIVE: Investigate whether an exercise intervention can enhance mobility, prevent falls, and increase physical activity among community-dwelling people after stroke. METHOD: A randomized trial with blinding of physical outcome assessment was conducted through local stroke clubs. Both groups, on average 5.9 years poststroke, received exercise classes, advice, and a home program for 12 months. The experimental group (EG) program (n = 76) aimed to improve walking, prevent falls and increase physical activity. The control group (CG) program (n = 75) aimed to improve upper-limb and cognitive functions. The primary outcomes were walking capacity, walking speed measured before and after the intervention, and fall rates monitored monthly. RESULTS: At 12 months, the EG walked 34 m further in 6 minutes (95% confidence interval [CI] = 19-50; P < .001) and 0.07 m/s faster over 10 m (95% CI = 0.01-0.14; P = .03) than the CG. The EG had 129 falls, and the CG had 133. There were no differences in proportion of fallers (relative risk = 1.22; 95% CI = 0.91-1.62; P = .19) or the rate of falls between groups (incidence rate ratio = 0.96; 95% CI = 0.59-1.51; P = .88). CONCLUSION: The experimental intervention delivered through stroke clubs enhanced aspects of mobility but had no effect on falls.

Predictors of adherence to a structured exercise program and physical activity participation in community dwellers after stroke.

Aim. To investigate predictors of adherence to group-based exercise and physical activity participation among stroke survivors. Methods. 76 stroke survivors participated (mean age 66.7 years). Adherence was the percentage of classes attended over one year. Physical activity was the average pedometer steps/day measured over seven days at the end of the trial. Possible predictors included baseline measures of demographics, health, quality of life, falls, fear of falling, cognition, and physical functioning. Results. Mean class attendance was 60% (SD 29%). Only one variable (slow choice stepping reaction time) was an independent predictor of higher class attendance, explaining 5% of the variance. Participants completed an average of 4,365 steps/day (SD 3350). Those with better physical functioning (choice stepping reaction time, postural sway, maximal balance range, 10-m walk, or 6-min walk) or better quality of life (SF-12 score) took more steps. A model including SF-12, maximal balance range, and 6-min walk accounted for 33% of the variance in average steps/day. Conclusions. The results suggest that better physical functioning and health status are predictors of average steps taken per day in stroke survivors and that predicting adherence to group exercise in this group is difficult.

Exercise intervention to prevent falls and enhance mobility in community dwellers after stroke: a protocol for a randomised controlled trial.

BACKGROUND: Stroke is the most common disabling neurological condition in adults. Falls and poor mobility are major contributors to stroke-related disability. Falls are more frequent and more likely to result in injury among stroke survivors than among the general older population. Currently there is good evidence that exercise can enhance mobility after stroke, yet ongoing exercise programs for general community-based stroke survivors are not routinely available. This randomised controlled trial will investigate whether exercise can reduce fall rates and increase mobility and physical activity levels in stroke survivors. METHODS AND DESIGN: Three hundred and fifty community dwelling stroke survivors will be recruited. Participants will have no medical contradictions to exercise and be cognitively and physically able to complete the assessments and exercise program. After the completion of the pre-test assessment, participants will be randomly allocated to one of two intervention groups. Both intervention groups will participate in weekly group-based exercises and a home program for twelve months. In the lower limb intervention group, individualised programs of weight-bearing balance and strengthening exercises will be prescribed. The upper limb/cognition group will receive exercises aimed at management and improvement of function of the affected upper limb and cognition carried out in the seated position. The primary outcome measures will be falls (measured with 12 month calendars) and mobility. Secondary outcome measures will be risk of falling, physical activity levels, community participation, quality of life, health service utilisation, upper limb function and cognition. DISCUSSION: This study aims to establish and evaluate community-based sustainable exercise programs for stroke survivors. We will determine the effects of the exercise programs in preventing falls and enhancing mobility among people following stroke. This program, if found to be effective, has the potential to be implemented within existing community services. TRIAL REGISTRATION: The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12606000479505).