NCT06843486

SB: Promoting Bone Health in Women

Strong Bones: Promoting Bone Health and Quality of Life in Postmenopausal Women.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Instituto Politécnico de Bragança · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to find out whether multicomponent training works to treat osteoporosis in women. It will also find out about the safety of multicomponent training in this specific population. The main questions it aims to answer are: Does multicomponent training improve bone mineral density in women? What are the benefits of multicomponent training? The researchers will compare the intervention group (MTC) with a control group that did not perform any type of intervention, to see if MTC training works in treating bone mineral density in women. The participants will: Perform MTC training for 6 months with a frequency of 3 times a week in sessions of 40-60 minutes. While the control group will carry out their daily activities normally and will only attend on the days of the assessments.

Detailed description

The Strong Bones Project is a randomized controlled trial (RCT) investigating the effects of Multicomponent Training (MCT) on bone mineral density (BMD), quality of life, and risk of osteoporosis in women. The study adopts a hybrid approach combining cross-sectional observational analyses and randomized experimental interventions. Participants will be randomly allocated to an intervention group and a control group, allowing comparison of the impacts of MCT. The interventions include a structured physical exercise program, with three distinct approaches: 1. In-Person Supervised Multicomponent Training (MCT In-Person) 2. Control Group (No active intervention, only clinical monitoring) Training sessions will include aerobic, resistance, balance, and flexibility exercises, following the American College of Sports Medicine (ACSM) guidelines for osteoporosis prevention. Data collection will include: * Sociodemographic data * Bone mineral density (BMD), assessed by DXA (Dual-Energy X-ray Absorptiometry) * Functional fitness tests (e.g. handgrip strength test) Participants will be followed for 6 months, with monthly assessments to monitor the progression of clinical variables. Expected results include improved bone density, reduced risk of fractures, and improved quality of life. The findings will be disseminated through scientific publications in peer-reviewed journals and presentations at international conferences on bone health and physical exercise. This study seeks to contribute to the formulation of personalized physical exercise guidelines for the prevention of osteoporosis, especially in premenopausal women and men at intermediate risk of the disease.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
OTHER	Multicomponent Exercise	Training sessions will include aerobic, resistance, balance and flexibility exercises, following the American College of Sports Medicine (ACSM) guidelines for osteoporosis prevention.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-05-02
• Completion: 2025-05-02
• First posted: 2025-02-25
• Last updated: 2025-05-06

Locations

1 site across 1 country: Portugal