Effects of an Exercise Program on Bone Density

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

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.

Study Overview

• Status: Completed
• Conditions: Body Composition; Bone Density
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Intervention Group; 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; Aerobic exercise program

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid

Publications and helpful links

General Publications

• Iturriaga T, Barcelo O, Diez-Vega I, Cordero J, Pulgar S, Fernandez-Luna A, Perez-Ruiz M. Effects of a short workplace exercise program on body composition in women: A randomized controlled trial. Health Care Women Int. 2020 Feb;41(2):133-146. doi: 10.1080/07399332.2019.1679813. Epub 2019 Oct 22.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Actual): July 8, 2017
• Study Completion (Actual): July 23, 2017

Study Registration Dates

• First Submitted: October 7, 2017
• First Submitted That Met QC Criteria: October 7, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: P2016/UEM33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No