None listed
Conditions
Brief summary
This study aims to deliver health care in a novel way by creating an opportunity for people with osteoporosis and osteoporotic fracture to engage in an exercise program within their own home. Participants will be recruited from the Osteoporosis Re-fracture Prevention service at Westmead Hospital and will be randomly allocated to one of two treatment groups: 1) usual care for people with osteoporotic fractures, and 2) usual care for people with osteoporotic fractures, plus participating in a 6-month online exercise program. This study will also have a control group of participants with osteoporosis who have not had an osteoporotic fracture. The findings from this study will help to determine whether an online exercise program can improve the effectiveness of standard bone treatment in reducing the rate of re-fracture and improving other health outcomes for people with osteoporosis and osteoporotic fracture. The study will also provide insight into the safety, adherence and feasibility of an online exercise program for people with osteoporosis.
Interventions
Participants with osteoporosis and a previous minimal trauma fracture will be randomly allocated to one of two treatment arms: 1) usual care for individuals with osteoporotic fractures. This involves pharmacologic intervention, specifically bisphosphonates for this age group (55-75 years), and education on engaging in bone-promoting activities within their lifestyle; 2) usual care for individuals with osteoporotic fractures, including pharmacologic intervention as well as, participating in a 6-month online exercise program. The pharmacologic intervention will encompass standard medication given to patients with osteoporosis and minimal trauma fracture. This includes antiresorptive agents (5mg zoledronic acid administered intravenously once per year), vitamin D supplementation if levels are <50 nmol/L, or calcium supplementation if required. The study physician will determine the requirement for pharmacologic intervention. Compliance to pharmacologic intervention will be determined through a follow-up phone call initially (2 months after treatment initiation) and via patient medical interviews at follow-up assessments (6 months, 12 months, and 24 months). The education component will involve all participants being given an information resource that outlines the benefits of exercise in relation to osteoporosis, and provides a general overview of the exercise modalities most suitable for bone health (weight-bearing exercise, strength training and balance training). It also contains some points on safety considerations and activities that are not conducive to bone health (e.g. nonweight-bearing aerobic exercise). This information resource is designed as a 2 page fact sheet and will be handed to participants during the study’s baseline assessment. The online exercise intervention will be delivered in real-time by an Accredited Exercise Physiologist, and will occur 2 times per week, with each session being 45 minutes in length. These classes will be designed to incorporate strength-based exercises, impact training and balance exercises to address the recommended national guidelines for exercise and osteoporosis. Considering the exercise program will be performed within the participants’ home environment, ensuring safety during exercise sessions will be paramount. The program will be set at moderate intensity (using the RPE 1-10 scale). The types of exercises included in the program will be strength-based (body weight and band exercises, e.g. sit-to-stands, standing hip abduction/extension, calf raises, incline push-ups, band pull-aparts, triceps extension), include moderate impact loading (e.g. heel drops, step-ups), and balance exercises (e.g. tandem stance, single leg stance). Regressions and progressions of each exercise will be instructed as an option for participants to engage in that is suited to their level. Attendance to the online exercise sessions will be recorded and used as a means to monitor adherence.
Sponsors
Study design
Eligibility
Inclusion criteria
The inclusion criteria consists of: 1. Osteoporosis diagnosis; 2. Aged 55-75 years; 3. History of one minimal trauma fracture that has fully healed (treatment groups only); 4. At least six months post-fracture (treatment groups only); and 5. Patients presenting to the Osteoporosis Re-fracture Prevention service at Westmead Hospital.
Exclusion criteria
The exclusion criteria consists of: 1. Severe osteoporosis (BMD T-score of < -3.5); 2. High falls risk, whereby it would be unsafe for the participant to engage in a home exercise program without the direct supervision of a qualified exercise professional; 3. Fracture that seriously limits mobility and movement; 4. Neurological disorder; 5. Neurodegenerative disorder; 6. Secondary osteoporosis; and 7. Patients with recurrent fractures.