None listed
Conditions
Brief summary
Falls and fragility fractures cause more days of hospitalization than most other diseases and account for over half of all injury-related healthcare costs. Current models of care for osteoporosis and fracture prevention focus on pharmaceuticals which reduce fracture risk by 20-50%, missing 50-60% of fracture cases in those with osteopenia (low bone density), and fail to reduce falls, a key contributor to fractures. Best practice clinical guidelines endorse the use of exercise and nutrition interventions with lifestyle risk factor management to reduce falls/fracture risk, but few evidence-based interventions have been translated into practice and long-term adherence to most effective centre/community exercise-nutrition programs is often poor. This suggests that current delivery models do not meet the needs of many individuals. Digital health technologies such as iPad/tablets and smartphones offer an equitable opportunity to increase the scope, utilization and effectiveness of best practice models of service delivery and care for falls/fracture prevention by delivering personalized programs and information, and supporting timely patient-practitioner communication. Therefore, the aim of this 12-month trial is evaluate the clinical and cost effectiveness of a multifaceted, person-centred, telehealth falls/fracture prevention program in people at increased falls/fracture risk. Key features of TeleFFIT are that it incorporates a home-based exercise program tailored to each individual's needs/preferences and is delivered through an exercise training app with ongoing exercise and nutritional support (health coaching) from qualified exercise professionals and dietitians, tailored health messages and access to evidence-based, online educational material to encourage self-care, and healthy lifestyle behaviour change strategies to optimize musculoskeletal health and mobility for older people with or at risk of osteoporosis, falls or fractures.
Interventions
TeleFFIT is a multifaceted, telehealth-based exercise and lifestyle risk factor management program that is designed to reduce the risk of falls and fracture in older people with or at risk of osteoporosis, falls and fractures. Following an initial health/medical/lifestyle assessment that includes identifying barriers/facilitators to exercise training and goal setting during a one-on-one consultation (~75-90 min) with an exercise practitioner (EP: exercise physiologist/physiotherapist), participa
TeleFFIT is a multifaceted, telehealth-based exercise and lifestyle risk factor management program that is designed to reduce the risk of falls and fracture in older people with or at risk of osteoporosis, falls and fractures. Following an initial health/medical/lifestyle assessment that includes identifying barriers/facilitators to exercise training and goal setting during a one-on-one consultation (~75-90 min) with an exercise practitioner (EP: exercise physiologist/physiotherapist), participants will be asked to exercise at home (or at a training facility if they prefer) thrice weekly for 12 months (~30 min sessions). Participants will be provided with exercise equipment (resistance bands, foam mat, stepping box or weights). The EP will prescribe each participant their own personalized exercise program via an exercise app (TeleHab) that includes narrated videos and instructions. The EP will determine an appropriate exercise program for each participant based on their medical history, previous exercise experience, previous/current musculoskeletal injuries or other co-morbidities and their baseline physical and functional test performance. All exercise programs (and sessions) will be remotely monitored by the EP via the app and with 12 (over 12 months) follow-up video consultations (~15-20 min) to provide support, advice and motivation. The exercise program will focus on three key components: "Strong" including resistance and weight-bearing exercises to strengthen bones and muscles; "Steady" including challenging balance, mobility and stepping activities to reduce the risk of falls and "Straight" including postural exercises to protect the spine and strengthen the back muscles. Participants will complete an initial 4-week familiarization phase of training after which they will be prescribed 4 x 12 week programs designed to be progressively more challenging. Participants will also be instructed to incorporate short bouts of daily stepping/weight-bearing 'activity snacking' exercises (~5 min/d) into their daily routine to further target bone strength and mobility. Participant adherence (and training dose, rating of perceived exertion and any pain) will be monitored directly via the exercise app and self-reported exercise calendars. Participants will also receive nutritional advice (4 sessions: 1 x 60 min plus 3 x ~30 min remotely via Zoom) throughout the study from a trained dietitian to encourage healthy eating behaviours related to adequate calcium and protein intake, fruits and vegetables and limiting alcohol intake. They will also be provided with evidence-based, online learning modules/educational videos related to musculoskeletal health and function designed specifically for this study to promote self-management and mitigate the future risk of falls/fractures. To provide further support to adopt long-term healthy lifestyle behaviour changes, participants will receive regular health (text) messages and tips on simple strategies to improve self-management behaviours to optimize their bone and muscle health and mobility. The text messages will be personalized based on participants falls history and functional performance (i.e. risk of future falls), and presence of osteopenia or osteoporosis. Participants will receive 4-5 text messages per week in the first 8 weeks of the study and first 4 weeks of each new exercise program, and 2-3 messages per week for the remaining intervention. Adherence to, and perceived usefulness of, online learning modules/educational videos, nutritional advice and text messages for the adoption of healthy lifestyle behaviours will be assessed via questionnaire. Upon completion of the intervention, all EPs and dietitians delivering the intervention and a subset of approximately 24 participants will be purposively sampled (based on age, gender, program adherence and individual program effectiveness to ensure a range of views are obtained) to participate in semi-structured interviews to explore intervention implementation barriers and facilitators and factors related to future scalability. All participants in the intervention group will be asked to complete an evaluation survey upon completion of the study. A workshop will also be held with key stakeholders and consumers prior to the intervention to discuss potential scalability.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must be aged 60 years and over and classified at increased risk for falls/fracture defined as: 1) the presence of osteoporosis (as diagnosed by a doctor) or confirmed by a DXA scan during screening at Deakin University (proximal femur scan T-score equal to or less than -2.5 SD); 2) currently (or previously) treated for osteoporosis by medication, or 3) a previous history of a minimal trauma fracture (defined as a fracture resulting from trauma equal to (or less than) a fall from standing height) since the age of 50 years or at least 1 fall in the past 12 months, or at increased falls risk (score 3 or more) based on our Falls/Fracture risk questionnaire in combination with the presence of low BMD (osteopenia or osteoporosis) at the proximal femur (T-score <-1.0) as determine by DXA. To be included in the study, participants must also have access to a smart device/computer (including wi-fi/internet) and capable of making and receiving telephone and/or video conferencing calls and messaging (text/SMS), be willing to be randomized to either the TeleFFIT intervention (and undertake exercise for 12 months) or the usual care group and understand all the study requirements.
Exclusion criteria
Participants will be excluded from the study based on the following: 1) history of a hip fracture in the past year; 2) acute/terminal illness, medical disorder or recent surgery likely to limit training or regular use of a walking frame; 3) currently being treated for cancer (or if treatment ceased in the past 3 months); 4) any progressive neurological condition (eg Parkinson’s disease, dementia/Alzheimer’s disease) or palliative condition; 5) currently involved in a regular structured exercise training program (resistance training, weight bearing exercises) or falls prevention program more than once a week; 6) BMI <18 or >40; 7) non-English speaking; 8) current and ongoing use of glucocorticoids, if >7.5 mg/d and for >3 months; aromatase inhibitors or anti-androgen therapy; 9) no access to a smart device/phone; 10) recent (last 3 months) or considering gastric bypass surgery in the next 12 months; 11) impaired capacity or unable to provide informed consent (inability to understand – reiterate – the purpose of the study and its requirements); 12) For those who do not pass the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool, their GP does not provide consent for them to participate.
Outcome results
None listed