Effects of an Exercise Program on Bone Density

Study Overview
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Brief Summary
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Physical inactivity and low adherence to the Mediterranean diet cause alterations in body composition, which increases the risk factors for cardiovascular and metabolic diseases. In addition, exercise in different surfaces or water could affect the bone density specially in women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic exercise program in different surfaces on the body composition and bone density of women within at work, and to evaluate the quality of the Mediterranean diet and distribution of macronutrients in the studied population. Material & Methods: Randomized controlled trial. 63 women from a randomized work environment (IG, n=34) and a control group (CG, n=29) participated in a short-term aerobic exercise programmed (12 weeks), for body composition and bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for macronutrient distribution were used.

Official Title
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Effects of Exercise in Different Sport Surfaces, Diet and Lifestyle in the Bone Density of Pre and Post Menopausal Women

Conditions
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Bone Density, Body Composition

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not diagnosed with any disease that contraindicates the practice of physical exercise Do not perform physical activity with continuity Exclusion Criteria: Diagnosed with chronic disease including cardiovascular and respiratory diseases that contraindicate the practice of physical exercise Being pregnant before or during the intervention (for intervention and control group)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br> | |
| Experimental: Intervention Group<br>A moderate-intensity aerobic physical exercise programme was carried out during the months of March to May 2017 (12 weeks), with a frequency of three sessions per week (36 sessions in total) with a duration of 45 minutes per session. The intensity was controlled through the Borg 1982 modified scale of perceived exertion (RPE). It is a scale from 0 to 10, considering 0 as nothing at all and 10 as very very strong, setting the moderate intensity as value | Other: Exercise<br>* Aerobic exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone density | Change from baseline to 3 months using Dual-energy X-ray Absorptiometry | 3 months | 
| Changes in body composition | Change from baseline to 3 months using Dual-energy X-ray Absorptiometry | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of compliance with the exercise program | Level of compliance with the program using the percentage of compliance to the exercise programme (36 sessions) | 3 months | 
| Changes in Dietary pattern variables: macronutrients | Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries | 3 months | 
| Changes in Dietary pattern variables: quality of diet | Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries | 3 months |