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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03091088
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Information provided by (Responsible Party):
CARMEN GARCÍA GOMARIZ, University of Valencia

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.

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Osteoporosis, Osteopenia Physical Activity Other: walking at an intense pace Other: osteoporosis specific-oriented training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efecto de Dos Tipos de Ejercicio físico Para Prevenir la Osteoporosis en Mujeres Postmenopausicas, un Ensayo Clinico Aleatorizado
Actual Study Start Date : February 1, 2011
Actual Primary Completion Date : July 1, 2013
Actual Study Completion Date : December 30, 2016

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Postmenopausal woman
  • Pharmacological treatment (VitaminD+Calcium)

Exclusion Criteria:

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CARMEN GARCÍA GOMARIZ, PhD, PT, University of Valencia Identifier: NCT03091088     History of Changes
Other Study ID Numbers: ID_OW
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases