Artificial Intelligence and mHealth to Determine the response to a LIfestyle intervention for the primary prevention of Osteoporosis and frailty fractures in Postmenopausal women

The project is a single-blind (assessor), three-arm, randomized, controlled trial. Eligible participants will be randomly assigned (1: 1: 1) to three groups: (i) a lifestyle modification program increasing impacts and physical activity level with a duration of 9 months (EV), (ii) the same program, but supplemented with strength training at home, twice a week (EV + F), or (iii) an unsupervised control group (CON) that will continue with their usual treatment. Participants will be scheduled for three days to complete the measurement protocol. On the first day, they will attend the hospital and complete the sociodemographic and clinical information. They will then receive the accelerometer and all the questionnaires to be completed at home. In addition, from the hospital center, the participants will be summoned another day for the biochemical analysis, QCT and densitometry. On a second day, the participants will be summoned to the university laboratory to return the accelerometers and questionnaires, and they will take the physical condition tests. Finally, in a third visit to the laboratory, the participants will be familiarized with the use of the recording bracelet, with the strength training assessment device and with the session recording system (EV + F group). Finally, before the study begin, all participants will receive a daily vitamin D supplement (oral capsule) of 600 IU/day for 1 month. If serum levels are deficient, it will be supplied for 4 months (1 before and the first 3 of the intervention): 1 vial of 25,000 IU per month if <20ng/ml, 1 vial of 25000 IU every 15 days if <15ng/ml, 1 vial of 25,000 IU every week if <10 ng/ml. Calcium intake will be calculated using the 3-day recall and supplemented up to 1200 mg per day. Intervention (RCT with 3-arms) A. Program to increase physical activity and impacts For the intervention, a biosensor -wearable device- (Muvone ®, Secmotic, Spain) will be used, validated for the quantification of mechanical load during physical activity for the implementation of osteoporosis prevention programs. The device is linked to an App (Muvone) that will allow users to quantify the number of steps (including the rate of steps per minute), the impacts and their intensity. Users will be given feedback from the application on the level of achievement of the objectives proposed in the impact program (EV and EV + F). It will be proposed to achieve 50 vertical and multidirectional jumps per day (milestone 1. The number of jumps> 3.9 G per day will be recorded, divided between 3-5 sets of 10-20 repetitions with a minimum 1-2 minute rest between sets (aprox. 15 min per day). A frequency between 4-7 days per week will be used (which will gradually increase in the intervention). In the same way (increasing frequency from 4 to 7 days per week), it will be recommended to reach 10,000 steps per day (milestone 2. The number of daily steps will be recorded) and, as far as possible, at a rapid pace (milestone 3. The number of daily minutes walking at a pace over 110 steps/minute will be recorded, as this is considered the threshold of moderate-vigorous intensity in this age range. Therefore, according to the new WHO guidelines on physical activity and sedentary behavior, it will be quantified whether 150 minutes a week of moderate-vigorous physical activity are achieved. In parallel, the participants in both groups will receive recipes rich in calcium, designed specifically for this study, through the App and will have a calculator to calculate the intake of calcium and other micronutrients through the diet. They will also receive information on osteoporosis and strategies for its prevention (e.g., advice on sun exposure). Different strategies (i.e., accessing app analytics) will be used to monitor adherence to the program. B. Strength training program at home Along with the above program, participants assigned to the EV + F group will undergo two weekly unsupervised strength training sessions that will include a 10-minute warm-up period with walking and mobility exercises (e.g. Slowly rock forward onto your toes, lateral lunges…), followed by 20 to 42 minutes of a core-based exercise program. in a circuit training with strength exercises in a staggered progression during the program. The workout will include 2–3 sets of 5–10 exercises. Participants will perform 8 to 20 repetitions of multi-joint exercises aimed at the main muscle groups (especially those involved in the hip and spine), such as squats, deadlifts, hip extensions, hip abductions, knee flexion-extensions or rowing exercises. The total duration of each session will range between approximately 45 min and 1 hour. All exercises will be performed using a Handy Gym Dynamic device (Handy Gym, RecoveryTroop, Spain). This device allows 12 levels of progression and up to a load equivalent to 100 kg (combination of discs with an inertia from 6.3 Kg/cm2 to 15.5 kg/cm2). The load will gradually increase by varying said inertia (from inertia 1-2 blue discs- to inertia 12-2 red discs) and each participant will individualize their effort to reach the intensity designed for each session. Perceived exertion (RPE) will be recorded using a Borg CR-10 scale. The intensity (expressed as RPE) is expected to range between 5 and 10. Through the Handy Gym App, the exercises performed, and the volume (series, repetitions, and times) will be recorded, as well as the associated kinetic variables (e.g., strength and power). Sessions will end with a 5-8 minute recovery period of stretching and relaxation exercises. Again, the adherence to the program will be monitored through the app. Participants will also receive access to a YouTube channel, which will provide step-by-step instructions for each exercise progression designed specifically for this study. Participants will be contacted weekly (5-10 minute telephone call or via Whatsapp) by a study researcher (physical therapist) to maintain regular interaction, assess progress and reinforce completion of the training diary.