Tailored Exercise and Home Hazard Reduction Program for Fall Prevention in Older People With Cognitive Impairment: The i-FOCIS Randomized Controlled Trial.

BACKGROUND: The evidence to support effective fall prevention strategies in older people with cognitive impairment (CI) is limited. The aim of this randomized controlled trial (RCT) was to determine the efficacy of a fall prevention intervention in older people with CI. METHOD: RCT involving 309 community-dwelling older people with CI. The intervention group (n = 153) received an individually prescribed home hazard reduction and home-based exercise program during the 12-month study period. The control group (n = 156) received usual care. The primary outcome was rate of falls. Secondary outcomes included faller/multiple faller status, physical function, and quality of life. RESULTS: Participants' average age was 82 years (95% CI 82-83) and 49% were female. There was no significant difference in the rate of falls (incidence rate ratio [IRR] 1.05; 95% confidence interval [95% CI] 0.73-1.51). A sensitivity analysis, controlling for baseline differences and capping the number of falls at 12 (4 participants), revealed a nonsignificant reduction in fall rate in the intervention group (IRR 0.78; 95% CI 0.57-1.07). Analyses of secondary outcomes indicated the intervention significantly reduced the number of multiple fallers by 26% (RR 0.74; 95% CI 0.54-0.99) when adjusting for baseline differences. There was a differential impact on falls in relation to physical function (interaction term p-value = .023) with a significant reduction in fall rate in intervention group participants with better baseline physical function (IRR 0.60; 95% CI 0.37-0.98). There were no significant between-group differences for other secondary outcomes. CONCLUSIONS: This intervention did not significantly reduce the fall rate in community-dwelling older people with CI. The intervention did reduce the fall rate in participants with better baseline physical function. CLINICAL TRIALS REGISTRATION NUMBER: Australian and New Zealand Trials Registry ACTRN12614000603617.

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.

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.

Exercise for falls prevention in Parkinson disease: a randomized controlled trial.

OBJECTIVE: To determine whether falls can be prevented with minimally supervised exercise targeting potentially remediable fall risk factors, i.e., poor balance, reduced leg muscle strength, and freezing of gait, in people with Parkinson disease. METHODS: Two hundred thirty-one people with Parkinson disease were randomized into exercise or usual-care control groups. Exercises were practiced for 40 to 60 minutes, 3 times weekly for 6 months. Primary outcomes were fall rates and proportion of fallers during the intervention period. Secondary outcomes were physical (balance, mobility, freezing of gait, habitual physical activity), psychological (fear of falling, affect), and quality-of-life measures. RESULTS: There was no significant difference between groups in the rate of falls (incidence rate ratio [IRR] = 0.73, 95% confidence interval [CI] 0.45-1.17, p = 0.18) or proportion of fallers (p = 0.45). Preplanned subgroup analysis revealed a significant interaction for disease severity (p < 0.001). In the lower disease severity subgroup, there were fewer falls in the exercise group compared with controls (IRR = 0.31, 95% CI 0.15-0.62, p < 0.001), while in the higher disease severity subgroup, there was a trend toward more falls in the exercise group (IRR = 1.61, 95% CI 0.86-3.03, p = 0.13). Postintervention, the exercise group scored significantly (p < 0.05) better than controls on the Short Physical Performance Battery, sit-to-stand, fear of falling, affect, and quality of life, after adjusting for baseline performance. CONCLUSIONS: An exercise program targeting balance, leg strength, and freezing of gait did not reduce falls but improved physical and psychological health. Falls were reduced in people with milder disease but not in those with more severe Parkinson disease. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with Parkinson disease, a minimally supervised exercise program does not reduce fall risk. This study lacked the precision to exclude a moderate reduction or modest increase in fall risk from exercise. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12608000303347).

Predictors of Adherence to a Falls Prevention Exercise Program for People with Parkinson's Disease.

BACKGROUND: Long-term benefits of exercise for people with Parkinson's disease (PD) require regular and sustained participation. This study aimed to investigate predictors of adherence to a minimally supervised exercise program designed to reduce falls in people with PD. METHOD: People with idiopathic PD who participated in the exercise arm of a randomized, controlled trial were included. Exercises were prescribed three times per week for 6 months. Adherence was defined as the percentage of prescribed sessions participants reported as having undertaken. Potential predictors of adherence included baseline measures of demographic variables, disease severity and duration, falls and fear of falling, pain, self-reported health and quality of life, cognition, physical activity levels, freezing of gait, functional mobility and balance, and knee extensor strength. RESULTS: The 108 participants included undertook a mean of 72% (standard deviation: 38%) of prescribed sessions. Participants had higher levels of adherence if they had shorter disease duration, less bodily pain, and better self-reported health and quality of life. A multivariate model (including disease duration, severity of bodily pain, self-reported physical well-being, the Frontal Assessment Battery, the Short Physical Performance Battery, and maximum walking time) explained 9% of the variance in exercise adherence, with shorter disease duration and less pain the strongest predictors (both predictors standardized ß = -0.2; P = 0.04). CONCLUSION: Disease duration and pain are likely to negatively influence exercise participation in people with PD. Given that most of the variance in adherence is unexplained, further work is required to determine other predictors of adherence to long-term exercise programs.

A post-hospital home exercise program improved mobility but increased falls in older people: a randomised controlled trial.

BACKGROUND: Home exercise can prevent falls in the general older community but its impact in people recently discharged from hospital is not known. The study aimed to investigate the effects of a home-based exercise program on falls and mobility among people recently discharged from hospital. METHODS AND FINDINGS: This randomised controlled trial (ACTRN12607000563460) was conducted among 340 older people. Intervention group participants (n = 171) were asked to exercise at home for 15-20 minutes up to 6 times weekly for 12 months. The control group (n = 169) received usual care. Primary outcomes were rate of falls (assessed over 12 months using monthly calendars), performance-based mobility (Lower Extremity Summary Performance Score, range 0-3, at baseline and 12 months, assessor unaware of group allocation) and self-reported ease of mobility task performance (range 0-40, assessed with 12 monthly questionaries). Participants had an average age of 81.2 years (SD 8.0) and 70% had fallen in the past year. Complete primary outcome data were obtained for at least 92% of randomised participants. Participants in the intervention group reported more falls than the control group (177 falls versus 123 falls) during the 12-month study period and this difference was statistically significant (incidence rate ratio 1.43, 95% CI 1.07 to 1.93, p = 0.017). At 12-months, performance-based mobility had improved significantly more in the intervention group than in the control group (between-group difference adjusted for baseline performance 0.13, 95% CI 0.04 to 0.21, p = 0.004). Self-reported ease in undertaking mobility tasks over the 12-month period was not significantly different between the groups (0.49, 95% CI -0.91 to 1.90, p = 0.488). CONCLUSIONS: An individualised home exercise prescription significantly improved performance-based mobility but significantly increased the rate of falls in older people recently discharged from hospital. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12607000563460.

Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment: protocol paper for the i-FOCIS randomised controlled trial.

BACKGROUND: The rate of falls in community dwelling older people with cognitive impairment (CI) is twice that of a cognitively intact population, with almost two thirds of people with CI falling annually. Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people. However the potential benefit of these interventions in reducing falls in people with CI has not been established.This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI. We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers. A health economic analysis examining the cost and potential benefits of the program will also be undertaken. METHODS AND DESIGN: Three hundred and sixty people aged 65 years or older living in the community with CI will be recruited to participate in the trial. Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week.Participants will undergo an assessment at baseline with retests at 6 and 12 months. Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities.The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars. Secondary outcome measures will include the risk of falling, quality of life, measures of physical and cognitive function, fear of falling and planned and unplanned use of health services. Carers will be followed up to determine carer burden, coping strategies and quality of life. DISCUSSION: The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program. The results will have direct implications for the design and implementation of interventions for this high-risk group of older people. TRIAL REGISTRATION: The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry - ACTRN12614000603617.

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.

The effects of an exercise program on fall risk factors in people with Parkinson's disease: a randomized controlled trial.

This randomized controlled trial with blinded assessment aimed to determine the effect of a 6-month minimally supervised exercise program on fall risk factors in people with Parkinson's disease (PD). Forty-eight participants with PD who had fallen or were at risk of falling were randomized into exercise or control groups. The exercise group attended a monthly exercise class and exercised at home three times weekly. The intervention targeted leg muscle strength, balance, and freezing. The primary outcome measure was a PD falls risk score. The exercise group had no major adverse events and showed a greater improvement than the control group in the falls risk score, which was not statistically significant (between group mean difference = -7%, 95% CI -20 to 5, P = 0.26). There were statistically significant improvements in the exercise group compared with the control group for two secondary outcomes: Freezing of Gait Questionnaire (P = 0.03) and timed sit-to-stand (P = 0.03). There were statistically nonsignificant trends toward greater improvements in the exercise group for measures of muscle strength, walking, and fear of falling, but not for the measures of standing balance. Further investigation of the impact of exercise on falls in people with PD is warranted.

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).

Minimising disability and falls in older people through a post-hospital exercise program: a protocol for a randomised controlled trial and economic evaluation.

BACKGROUND: Disability and falls are particularly common among older people who have recently been hospitalised. There is evidence that disability severity and fall rates can be reduced by well-designed exercise interventions. However, the potential for exercise to have these benefits in older people who have spent time in hospital has not been established.This randomised controlled trial will investigate the effects of a home-based exercise program on disability and falls among people who have had recent hospital stays. The cost-effectiveness of the exercise program from the health and community service provider's perspective will be established. In addition, predictors for adherence with the exercise program will be determined. METHODS AND DESIGN: Three hundred and fifty older people who have recently had hospital stays will participate in the study. Participants will have no medical contraindications to exercise and will be cognitively and physically able to complete the assessments and exercise program.The primary outcome measures will be mobility-related disability (measured with 12 monthly questionnaires and the Short Physical Performance Battery) and falls (measured with 12 monthly calendars). Secondary measures will be tests of risk of falling, additional measures of mobility, strength and flexibility, quality of life, fall-related self efficacy, health-system and community-service contact, assistance from others, difficulty with daily tasks, physical activity levels and adverse events.After discharge from hospital and completion of all hospital-related treatments, participants will be randomly allocated to an intervention group or usual-care control group. For the intervention group, an individualised home exercise program will be established and progressed during ten home visits from a physiotherapist. Participants will be asked to exercise at home up to 6 times per week for the 12-month study period. DISCUSSION: The study will determine the impact of this exercise intervention on mobility-related disability and falls in older people who have been in hospital as well as cost-effectiveness and predictors of adherence to the program. Thus, the results will have direct implications for the design and implementation of interventions for this high-risk group of older people. TRIAL REGISTRATION: The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12607000563460.

Exercise therapy for prevention of falls in people with Parkinson's disease: a protocol for a randomised controlled trial and economic evaluation.

BACKGROUND: People with Parkinson's disease are twice as likely to be recurrent fallers compared to other older people. As these falls have devastating consequences, there is an urgent need to identify and test innovative interventions with the potential to reduce falls in people with Parkinson's disease. The main objective of this randomised controlled trial is to determine whether fall rates can be reduced in people with Parkinson's disease using exercise targeting three potentially remediable risk factors for falls (reduced balance, reduced leg muscle strength and freezing of gait). In addition we will establish the cost effectiveness of the exercise program from the health provider's perspective. METHODS/DESIGN: 230 community-dwelling participants with idiopathic Parkinson's disease will be recruited. Eligible participants will also have a history of falls or be identified as being at risk of falls on assessment. Participants will be randomly allocated to a usual-care control group or an intervention group which will undertake weight-bearing balance and strengthening exercises and use cueing strategies to address freezing of gait. The intervention group will choose between the home-based or support group-based mode of the program. Participants in both groups will receive standardized falls prevention advice. The primary outcome measure will be fall rates. Participants will record falls and medical interventions in a diary for the duration of the 6-month intervention period. Secondary measures include the Parkinson's Disease Falls Risk Score, maximal leg muscle strength, standing balance, the Short Physical Performance Battery, freezing of gait, health and well being, habitual physical activity and positive and negative affect schedule. DISCUSSION: No adequately powered studies have investigated exercise interventions aimed at reducing falls in people with Parkinson's disease. This trial will determine the effectiveness of the exercise intervention in reducing falls and its cost effectiveness. This pragmatic 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 (ACTRN12608000303347).