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

NCT06741956 | Enrolling By Invitation

• 1 other identifier: PID2022-142316OB-I00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis in Post-menopausal Women; Prevention; Exercise; Physical Activity; Wearable Devices

Keywords

Osteoporosis prevention; Postmenopausal women; Bone mineral density; Fragility fractures; Physical activity interventions; Wearable technology; Non-pharmacological management; Machine learning in healthcare

Outcome Measures

Primary Outcomes (2)

• Bone density

  The BMD (g/cm2) of the lumbar vertebrae (L1-L4) and femur of the right leg (femoral neck, Ward's triangle, and greater trochanter) will be analyzed by a specialist technician outside the study. Values will be converted to T-score and Z-score based on the reference values for a Caucasian female and the bone density of the Spanish population, respectively. The device will be calibrated daily using a phantom.

  Pre (week 0) and post (week 36).

• Bone biomarkers

  To avoid diurnal variation, fasting blood samples will be collected between 8:00 and 10:00 in vacutainer tubes and aliquots will be stored frozen at -80ºC until analysis. Serum Β-CrossLaps (β-CTX) to assess bone resorption and P1NP, to assess bone remodeling, will be measured both at baseline and at 36 weeks by chemiluminescence (ECLIA) on a Modular Analytics E170 analyzer (Roche Diagnostics, Switzerland).

  Pre (week 0) and post (week 36).

Secondary Outcomes (15)

• Body composition

  Pre (week 0) and post (week 36).

• Quality of life

  Pre (week 0) and post (week 36).

• Symptoms of menopause

  Pre (week 0) and post (week 36).

• Mobility and dynamic balance

  Pre (week 0) and post (week 36).

• Strength

  Pre (week 0) and post (week 36).

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

A. Program to increase physical activity and impacts For the intervention, a biosensor -wearable device- (Fitbit Versa) will be used. The device is linked to an App (Weapom) 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). 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 28, divided between 3-5 sets of 10-20 repetitions with a minimum 1-2 minute rest between sets. A frequency between 4-7 days per week will be used. In the same way, 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

Behavioral: Weapom Lifestyle Intervention to measure bone impacts using a Fitbit Versa wearable device and the Weapom App.

Control

NO INTERVENTION

Participants randomly assigned to CON will receive general advice from medical staff on the positive effects of physical activity and nutritional aspects for the prevention of osteoporosis. Participants in this group will carry the device, but will not have access to the App.

Interventions

Weapom Lifestyle Intervention to measure bone impacts using a Fitbit Versa wearable device and the Weapom App. BEHAVIORAL

A. Program to increase physical activity and impacts For the intervention, a biosensor -wearable device- (Fitbit Versa) will be used. The device is linked to an App (Weapom) 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). 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 28, divided between 3-5 sets of 10-20 repetitions with a minimum 1-2 minute rest between sets. A frequency between 4-7 days per week will be used. In the same way, 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 r

Lifestyle intervention

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: The eligibility for this study is based on biological sex due to the specific focus on postmenopausal osteoporosis, a condition influenced by physiological and hormonal changes that occur in women after menopause. Gender identity does not limit participation, provided the individual meets the inclusion criteria based on biological and physiological factors associated with postmenopausal status.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Surgically induced menopause or cancer treatment.
• Low BMI (\<18 kg / m2).
• Excessive alcohol consumption (≥3 drinks per day).
• Smoker
• Unstable cardiovascular disease.
• Rheumatoid arthritis.
• Chronic kidney disease
• Diagnosis of conditions that alter bone metabolism (hypo/hypercalcemia, hyperthyroidism, hypo/hypergonadism).
• Upper or lower limb fracture in the last 6 months.
• Mobility problems or requiring assistance to walk.
• 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.
• Unwillingness to complete the study requirements.

Sponsors & Collaborators

• University of Seville: lead
• Hospitales Universitarios Virgen del Rocío: collaborator

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Spain, 41013, Spain

Location

Related Publications (1)

• Sanudo B, Reverte-Pagola G, Maher C, Godino J, Carrasco L, Oviedo MA, Feria A, Sanchez-Trigo H, Gamboa H, Domingo-Molina R, Sanchez-Arteaga A, Giraldez MA, Martinez-Maestre MA, Cepeda E, Ladron-de-Guevara C, Rangel C, Pecci J, Farrahi V, Tejero S. Effectiveness of an mHealth-based impact exercise program for bone health in postmenopausal women: a randomised controlled trial protocol. BMC Public Health. 2025 Jul 10;25(1):2426. doi: 10.1186/s12889-025-22576-9.

  PMID: 40640761 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Borja Sañudo, PhD

  University of Seville

  PRINCIPAL INVESTIGATOR

• Sergio Tejero, PhD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The WEAPOM project is a single-blind, randomized-controlled trial where only the outcome assessors are blinded. Eligible participants are randomly allocated in a 1:1 ratio to one of two groups. The masking ensures that assessors evaluating outcomes are unaware of participant group assignments, reducing bias in the assessment of results.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Physical Education and Sport

Model Details: The WEAPOM project is a single-blind (assessor), randomized-controlled trial. Eligible participants will be randomly assigned (1:1) to two groups: (i) a lifestyle modification program increasing impacts and physical activity level with a duration of 9 months (EV), or (ii) an unsupervised control group (CON) that will continue with their usual treatment.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 19, 2024
• Study Start: September 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

ES (1)