Effects of an Exercise Program on Bone Density

NCT03308292 | Completed

• 1 other identifier: P2016/UEM33
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Density; Body Composition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Level of compliance with the exercise program

  3 months

• Changes in Dietary pattern variables: macronutrients

  3 months

• Changes in Dietary pattern variables: quality of diet

  3 months

Study Arms (2)

Control Group

NO INTERVENTION

Intervention Group

EXPERIMENTAL

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

Interventions

Exercise OTHER

Aerobic exercise program

Intervention Group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Not diagnosed with any disease that contraindicates the practice of physical exercise
• Do not perform physical activity with continuity

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Related Publications (1)

• 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.

  PMID: 31638477 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2017
• First Posted: October 12, 2017
• Study Start: January 9, 2017
• Primary Completion: July 8, 2017
• Study Completion: July 23, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-10