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

Primary Purpose

Osteoporosis, Postmenopausal, Osteoporosis, Osteopenia, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
walking at an intense pace
osteoporosis specific-oriented training
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postmenopausal woman
  • Pharmacological treatment (VitaminD+Calcium)

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Experimental

    Arm Description

    walking at an intense pace

    osteoporosis specific-oriented training

    Outcomes

    Primary Outcome Measures

    Femoral neck T-score
    The score compares femoral neck bone mineral density to a reference mean
    Lumbar spine T-score
    The score compares lumbar spine bone mineral density to a reference mean

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2017
    Last Updated
    March 20, 2017
    Sponsor
    University of Valencia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03091088
    Brief Title
    Effects of Physical Exercise to Prevent Osteoporosis in Postmenopausal Women
    Acronym
    Osteo_women
    Official Title
    Efecto de Dos Tipos de Ejercicio físico Para Prevenir la Osteoporosis en Mujeres Postmenopausicas, un Ensayo Clinico Aleatorizado
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2011 (Actual)
    Primary Completion Date
    July 1, 2013 (Actual)
    Study Completion Date
    December 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Valencia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis, Postmenopausal, Osteoporosis, Osteopenia, Physical Activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    walking at an intense pace
    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    osteoporosis specific-oriented training
    Intervention Type
    Other
    Intervention Name(s)
    walking at an intense pace
    Intervention Description
    Participants walk 6 kilometers in 1 hour at least 3 times per week
    Intervention Type
    Other
    Intervention Name(s)
    osteoporosis specific-oriented training
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Femoral neck T-score
    Description
    The score compares femoral neck bone mineral density to a reference mean
    Time Frame
    Change from baseline score at two years
    Title
    Lumbar spine T-score
    Description
    The score compares lumbar spine bone mineral density to a reference mean
    Time Frame
    Change from baseline score at two years

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Postmenopausal woman Pharmacological treatment (VitaminD+Calcium) Exclusion Criteria: Disease or physical-mental condition which prevents to perform the proposed physical exercise

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29040219
    Citation
    Garcia-Gomariz C, Blasco JM, Macian-Romero C, Guillem-Hernandez E, Igual-Camacho C. Effect of 2 years of endurance and high-impact training on preventing osteoporosis in postmenopausal women: randomized clinical trial. Menopause. 2018 Mar;25(3):301-306. doi: 10.1097/GME.0000000000001005.
    Results Reference
    derived

    Learn more about this trial

    Effects of Physical Exercise to Prevent Osteoporosis in Postmenopausal Women

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