Wearable device lifestyle program to help prevent osteoporosis in women after menopause
Tests a wearable activity device and app to support bone health in women after menopause.
Plain-language title generated from the registry record
Registry title: Development of a Wearable Device for Osteoporosis Prevention and Fracture Risk Reduction in Women
Key facts
- Where
- Seville, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for inactive women who went through menopause in the last 10 years. It tests activity programs for bone health.
- Age
- Older than 40 years
- Sex
- Women only
- Disease stage
- Postmenopausal women up to 10 years after menopause
- Earlier treatment
- No exercise programs in the 6 months before the study. No regular glucocorticoids or hormone replacement therapy in the past 3 months.
Main reasons for not taking part
- Menopause caused by surgery or cancer treatment
- BMI below 18 kg/m2
- 3 or more alcoholic drinks per day, or smoking
- Unstable heart disease, rheumatoid arthritis or chronic kidney disease
- Limb fracture in the last 6 months or problems walking
Read by machine on 12 November 2026.
Where in Spain
- Hospital Universitario Virgen del RocioSeville, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Seville
- Trial code
- NCT06741956
- Record updated
- 19 December 2024
- Original description
This project aims to determine the impact on bone health of:Read full original descriptionShow less
Design, Validation and Implementation of a Wearable Device for the Primary Prevention of Osteoporosis and Distal Radius Fractures in Women
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.
Inclusion: Postmenopausal women older than 40 years with ≤ 10 years after menopause ("early postmenopausal women"); Sedentary women (defined as not performing regular physical activity greater than 150 min of moderate-vigorous physical activity per week in the last six months); Willing to give consent to participate in the study.
Exclusion: Participation in physical exercise programs in the 6 months prior to the study; Regular use of glucocorticoids or hormone replacement therapy in the past 3 months; Surgically induced menopause or cancer treatment; Unstable cardiovascular disease; Chronic kidney disease; Diagnosis of conditions that alter bone metabolism (hypo/hypercalcemia, hyperthyroidism, hypo/hypergonadism); Low BMI (<18 kg / m2); Excessive alcohol consumption (≥3 drinks per day); Smoker; Rheumatoid arthritis; Upper or lower limb fracture in the last 6 months; Mobility problems or requiring assistance to walk; Unwillingness to complete the study requirements.