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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The group will not receive any type of intervention | |
| Multicomponent Exercise | Experimental | Participants receive an intervention (a multi-component exercise program). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent Exercise | Other | Training sessions will include aerobic, resistance, balance and flexibility exercises, following the American College of Sports Medicine (ACSM) guidelines for osteoporosis prevention. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density (BMD) | Bone mineral density (BMD), measured in g/cm², assesses regions such as the lumbar spine, proximal femur, and total body. It is used to diagnose and monitor osteopenia and osteoporosis based on WHO criteria. The T-score, expressed in standard deviations (SD), compares the patient's BMD to that of a young, healthy population, classifying osteopenia (T-score -1.0 to -2.5 SD) and osteoporosis (T-score ≤ -2.5 SD). The Z-score compares BMD to age- and sex-matched averages, aiding in identifying secondary causes of osteoporosis. Dual-energy X-ray absorptiometry (DXA) is the standard method for measuring BMD. Additionally, DXA provides body composition analysis, offering data on bone mass (grams), lean mass (grams/kilograms), and body fat percentage (%). These parameters enable a comprehensive assessment of musculoskeletal health and nutritional status. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Limb Strength | Test: 30-Second Chair Stand Description: Participants sit on a standard chair (43 cm height) and stand up as many times as possible within 30 seconds, without using their arms for support. Unit of Measure: Number of repetitions in 30 seconds | From enrollment to the end of treatment at 6 months |
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Inclusion Criteria:
Previous diagnosis of osteoporosis confirmed by DXA (T-score between -1.0 and -2.5 for osteopenia and ≤ -2.5 for osteoporosis).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Politécnico de Bragança | Bragança | Braganza District | 5300-253 | Portugal |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| Upper Limb Strength |
Test: Arm Curl Test Description: Participants perform as many full biceps curls as possible within 30 seconds while holding a dumbbell (2.27 kg for women). Unit of Measure: Number of repetitions in 30 seconds |
| From enrollment to the end of treatment at 6 months |
| Lower Limb Flexibility | Test: Chair Sit-and-Reach Test Description: Participants sit on the edge of a chair with one leg extended and reach toward their toes. Unit of Measure: Distance between fingers and toes (centimeters) | From enrollment to the end of treatment at 6 months |
| Upper Limb Flexibility | Test: Back Scratch Test Description: Participants attempt to touch their fingertips behind their back, reaching one arm over the shoulder and the other behind the back. Unit of Measure: Distance between middle fingers (centimeters) | From enrollment to the end of treatment at 6 months |
| Agility/Balance | Test: Timed Up and Go (TUG) Test Description: Participants stand up from a chair, walk 2.45 meters, turn around, and return to the seated position as quickly as possible. Unit of Measure: Time to complete the test (seconds) | From enrollment to the end of treatment at 6 months |
| Aerobic Endurance | Test: 2-Minute Step Test Description: Participants march in place for two minutes, ensuring that their knee reaches a predefined height (midpoint between patella and iliac crest). Unit of Measure: Number of times the right knee reaches the marked height | From enrollment to the end of treatment at 6 months |
| D009750 |
| Nutritional and Metabolic Diseases |