Effects of Physical Exercise to Prevent Osteoporosis in Postmenopausal Women (Osteo_women)

March 20, 2017 updated by: CARMEN GARCÍA GOMARIZ, University of Valencia

Efecto de Dos Tipos de Ejercicio físico Para Prevenir la Osteoporosis en Mujeres Postmenopausicas, un Ensayo Clinico Aleatorizado

According to the World Health Organization criteria, osteoporosis was defined as a bone mineral density that lies 2.5 standard deviations or more below the average value for young healthy women. Osteoporosis is a major cause of fractures and can lead to serious complications in postmenopausal women. For this reason, approaches to prevent the appearance and progression of osteoporosis are of primary importance. This randomized clinical trial analyzes the effects of two types of physical exercise oriented to prevent osteoporosis in postmenopausal women with pharmacological supplements of Calcium and Vitamin-D.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal woman
  • Pharmacological treatment (VitaminD+Calcium)

Exclusion Criteria:

  • Disease or physical-mental condition which prevents to perform the proposed physical exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
walking at an intense pace
Other: walking at an intense pace
Participants walk 6 kilometers in 1 hour at least 3 times per week
Experimental: Experimental
osteoporosis specific-oriented training
Other: osteoporosis specific-oriented training
1 hour of physical activity, 2 times per week, based on the Asociación Española con la Osteoporosis y la Artrosis (AECOS) recommendations. Sessions are divided in 15 minutes of warmup (8 to 10, 60-second exercises), 30-35 minutes of combined exercises with loads and weights, as well as high intensity exercises, and 10-15 minutes of cooldown activities (based on Frederick relaxation techniques)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Femoral neck T-score
Time Frame: Change from baseline score at two years
The score compares femoral neck bone mineral density to a reference mean
Change from baseline score at two years
Lumbar spine T-score
Time Frame: Change from baseline score at two years
The score compares lumbar spine bone mineral density to a reference mean
Change from baseline score at two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

December 30, 2016

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID_OW

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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