Effects of Physical Exercise to Prevent Osteoporosis in Postmenopausal Women

Physical Activity Clinical Trial

— Osteo_women  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091088
• Other study ID #: ID_OW
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 20, 2017
• Start date: February 1, 2011
• Est. completion date: December 30, 2016

Study information

• Verified date: March 2017
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 30, 2016
• Est. primary completion date: July 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Postmenopausal woman

• Pharmacological treatment (VitaminD+Calcium)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteoporosis
• Osteoporosis, Osteopenia
• Osteoporosis, Postmenopausal
• Physical Activity

Intervention

Other:
• walking at an intense pace
Participants walk 6 kilometers in 1 hour at least 3 times per week
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoral neck T-score	The score compares femoral neck bone mineral density to a reference mean	Change from baseline score at two years
Primary	Lumbar spine T-score	The score compares lumbar spine bone mineral density to a reference mean	Change from baseline score at two years