Effects of an Exercise Program on Bone Density

Body Composition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308292
• Other study ID #: P2016/UEM33
• Status: Completed
• Phase: N/A
• First received: October 7, 2017
• Last updated: October 13, 2017
• Start date: January 9, 2017
• Est. completion date: July 23, 2017

Study information

• Verified date: October 2017
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 23, 2017
• Est. primary completion date: July 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Body Composition
• Bone Density

Intervention

Other:
• Exercise
Aerobic exercise program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in bone density	Change from baseline to 3 months using Dual-energy X-ray Absorptiometry	3 months
Primary	Changes in body composition	Change from baseline to 3 months using Dual-energy X-ray Absorptiometry	3 months
Secondary	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
Secondary	Changes in Dietary pattern variables: macronutrients	Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries	3 months
Secondary	Changes in Dietary pattern variables: quality of diet	Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries	3 months