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Completed

NCT Number: NCT03308292

Effects of an Exercise Program on Bone Density

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.

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Key information

Conditions

Bone Density Body Composition

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Other

Aerobic exercise program

Primary outcomes

  1. Changes in bone density

    Time frame: 3 months

    Change from baseline to 3 months using Dual-energy X-ray Absorptiometry

  2. Changes in body composition

    Time frame: 3 months

    Change from baseline to 3 months using Dual-energy X-ray Absorptiometry

Secondary outcomes

  1. Level of compliance with the exercise program

    Time frame: 3 months

    Level of compliance with the program using the percentage of compliance to the exercise programme (36 sessions)

  2. Changes in Dietary pattern variables: macronutrients

    Time frame: 3 months

    Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries

  3. Changes in Dietary pattern variables: quality of diet

    Time frame: 3 months

    Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2017
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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