Clinical Trial

Development of a Wearable Device for Osteoporosis Prevention and Fracture Risk Reduction in Women

Study acronym: Weapom
Enrolling by Invitation
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Record status
This record was last updated December 19, 2024 (before its estimated March 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This project aims to determine the impact on bone health of: A lifestyle intervention promoting impact-based activities and physical activity for nine months. The same program enhanced with home-based strength training. A control group without supervision, continuing with standard care. The study will evaluate the persistence of changes after these interventions during a 12-week follow-up. By employing diverse strategies, the project seeks to identify barriers and facilitators to using technology for promoting healthy lifestyles in this demographic. Additionally, it will, for the first time in Spain, establish predictive models to assess the efficacy of non-pharmacological interventions in osteoporosis prevention, in collaboration with the public health system. These models will also predict adherence to technology-based behavioral interventions. ELIGIBILITY CRITERIA Eligible Participants: Postmenopausal women aged \>40 years, within 8 years post-menopause. Sedentary lifestyle. Willingness to provide informed consent. Exclusion Criteria: Surgically induced menopause or cancer treatment. Low BMI (\<18 kg/m²). Excessive alcohol consumption (≥3 drinks/day). Smoking. Unstable cardiovascular disease, rheumatoid arthritis, chronic kidney disease. Diagnosed conditions altering bone metabolism (e.g., hyperthyroidism). Recent fractures or mobility limitations. Recent engagement in structured physical activity programs. Recent use of glucocorticoids or hormone replacement therapy. VARIABLES TO BE MONITORED Body Composition: Lean mass, fat mass, bone mass, and waist circumference. Bone Health: Bone density of lumbar vertebrae and femur via densitometry and microarchitecture evaluation using quantitative CT. Biomarkers: Assessment of bone resorption and remodeling markers. Physical Function: Functional assessments (e.g., gait speed, jumping ability, lower limb strength). Physical Activity: Objectively monitored with accelerometers, analyzing sedentary, light, and moderate-to-vigorous activities. Nutritional Intake: Monitored using dietary recall tools. Quality of Life: Assessed using the Menopause Rating Scale (MRS). TRAINING PROTOCOL A. Impact-Based Physical Activity Program: Participants will utilize a validated biosensor (Muvone®) to track steps and impacts, targeting 50 multidirectional jumps and 10,000 steps per day, emphasizing brisk walking. B. Home-Based Strength Training Program: Two weekly sessions, progressing from 20 to 42 minutes, targeting major muscle groups (e.g., squats, hip extensions). Sessions include warm-ups, multi-joint exercises, and recovery periods. C. Control Group: Participants receive general advice on physical activity and nutrition without supervised programs or app access. FOLLOW-UP After 36 weeks, participants will resume daily routines without app feedback. At the 12-week follow-up, they will return for questionnaires and physical assessments. This structured approach ensures rigorous evaluation and facilitates integration of findings into public health strategies.
Trial Details
NCT Number NCT06741956
Lead Sponsor University of Seville
Collaborators: Hospitales Universitarios Virgen del Rocío
Conditions Osteoporosis in Post-menopausal Women, Prevention, Exercise, Physical Activity, Wearable Devices
Enrollment 120 participants
Start Date 2023-09-01
Primary Completion 2025-03-01 (estimated)
Study Completion 2025-12-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-19