Effects of an Exercise Program on Bone Density

Not Applicable

Completed

• Conditions: Bone Density; Body Composition
• Interventions: Other: Exercise

• Registration Number: NCT03308292
• Lead Sponsor: Universidad Europea de Madrid

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-09
• Primary Completion: 2017-07-08
• Study Completion: 2017-07-23
• Status Verified: 2017-10
• Study First Submitted: 2017-10-07
• Study First Submitted QC: 2017-10-07
• Study First Posted: 2017-10-12
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Exercise	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

Primary Outcome Measures

Name	Time	Method
Changes in bone density	3 months	Change from baseline to 3 months using Dual-energy X-ray Absorptiometry
Changes in body composition	3 months	Change from baseline to 3 months using Dual-energy X-ray Absorptiometry

Secondary Outcome Measures

Name	Time	Method
Level of compliance with the exercise program	3 months	Level of compliance with the program using the percentage of compliance to the exercise programme (36 sessions)
Changes in Dietary pattern variables: macronutrients	3 months	Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries
Changes in Dietary pattern variables: quality of diet	3 months	Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries