None listed
Conditions
Brief summary
Despite its overwhelming benefits, a negative outcome of bariatric surgery is severe loss of bone and muscle mass. Postmenopausal women experience over two-fold greater bone microarchitecture deterioration than premenopausal women and men following bariatric surgery, and as such are at greatest risk for incident fractures. We have previously identified that supervised 30 minute, twice weekly functional impact training (FIT) in postmenopausal women with low bone mass resulted in significant improvements in lumbar spine and femoral neck bone mineral density (BMD) compared to control. No study has investigated the role of FIT in postmenopausal women following bariatric surgery using telehealth applications. We hypothesise that an 8-month functional and impact training (FIT) program combined with nutritional education, delivered via a mobile application, will be acceptable, safe, and well-adhered to in postmenopausal women following bariatric surgery. It is anticipated that the outcomes of the bariatric trial will inform the design of innovative future randomised controlled trials exploring this program as a potentially effective, safe, and feasible treatment strategy for maintaining musculoskeletal health after bariatric surgery.
Interventions
Participants allocated to the Functional Impact Training group in the present study will be given a structured 32-week, 30-minute, home-based Functional Impact Training program delivered by a commercial telehealth smartphone app (Physitrack). All exercises will be individually tailored and progressive, considering initial fitness, injuries or illness. Appropriate activities will be selected by the exercise physiologists using the clinician interface in Physitrack and individually broadcast to participants smart phone via the clinician interface in Physitrack at specified times throughout the day, using video demonstrations, and audio and written instructions. Following each exercise, Physitrack will broadcast questions to determine whether the participant completed the exercise, their self-perceived exertion, and any concerns (e.g. Pain, dizziness). Participants’ responses to these questions will be recorded and saved to the Physitrack database, enabling the exercise physiologist to review weekly and modify or progress exercise prescriptions as required. The prescribed exercise program will use body weight or additional resistance such as adjustable dumbbells, which will be provided. Participants will perform up to 1 set of 10 repetitions of all five exercises (1 strength-focused, 1 balance-focused, and 3 impact-focused) at a low intensity of approximately 1-3 on the 10-point modified Rating of Perceived Exertion (RPE) scale to serve as a warm-up as required. Participants will be then required to perform 5 sets of 10-20 repetitions, at a moderate-intensity of approximately 4-6 on the 10-point modified Rating of Perceived Exertion (RPE) scale. Each participant will be encouraged to increase the load of all the prescribed exercises each session while maintaining the desired intensity if able. The protocol will initially deliver three exercise sessions per week for the first eight weeks of the intervention, four exercise sessions per week for the second eight weeks, and five exercise sessions per week for the final sixteen weeks. General information on nutrition for musculoskeletal health will be presented fortnightly via Physitrack. The content delivered will be prepared by our dietitian colleagues and cover the following topic areas: “Bone Health and Bariatric Surgery”, “Dairy”, “Dairy Alternatives”, “Calcium”, “Protein”, “Vitamin D”, “Maintaining Healthy Diet Behaviours”, and “Overcoming Diet Setbacks” The delivery of information to patients will involve short (2-3 minute) educational videos as well as PDF information sheets and nutritional suggestions for increasing dairy, vitamin D and protein intake including examples of appropriate foods, meals and recipes. On a monthly basis, participants will receive questions via Physitrack to determine participants’ learning and adherence to recommendations.
Sponsors
Study design
Eligibility
Inclusion criteria
Prospective participants must be aged 50 years or older and postmenopausal (spontaneous amenorrhea for at least 12 months); community-dwelling, scheduled for any type of bariatric surgery within the next six months; have surgeon approval to commence FIT; English-speaking, able to walk across a room unaided; with access to a smartphone connected to an internet network; willing to complete an 8 month intervention and also be willing to participate should they be randomised to either intervention arm.
Exclusion criteria
Participants are ineligible if they currently reside in a nursing home; are unable to walk across a room unaided, are non-English speaking or have difficulty communicating with study personnel due to speech or hearing problems; have body weight greater than 200kg (upper weight limit for DXA); have had lower limb joint injury or surgery in past 6 months; fracture within the last 6 months; have conditions known to influence bone health; use drugs that interfere with bone metabolism; pre-existing malabsorption or protein supplement use; are planning to be away from home for 4 weeks during the intervention; and self-reported diagnosis of: progressive neurological disorders; severe knee or hip osteoarthritis that would interfere with ability to complete functional exercise and tests; cardiovascular disease; lung disease requiring regular use of corticosteroids or supplemental oxygen; renal disease requiring dialysis; hyper- or hypothyroidism that would interfere with the weight loss program; or any cognitive or physical impairment or disability that in the opinion of the participant’s’ GP/specialist and/or study investigators would result in the participant having difficulty interacting with the Physitrack application or performing unsupervised exercise safely. Finally, participants must answer ‘no’ to all six questions on the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool to ensure that it is safe for them to exercise at moderate exertion.