Effects of Physical Exercise to Prevent Osteoporosis in Postmenopausal Women
Osteo_women
Efecto de Dos Tipos de Ejercicio físico Para Prevenir la Osteoporosis en Mujeres Postmenopausicas, un Ensayo Clinico Aleatorizado
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2016
CompletedFirst Submitted
Initial submission to the registry
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
March 27, 2017
CompletedMarch 27, 2017
March 1, 2017
2.4 years
March 14, 2017
March 20, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Femoral neck T-score
The score compares femoral neck bone mineral density to a reference mean
Change from baseline score at two years
Lumbar spine T-score
The score compares lumbar spine bone mineral density to a reference mean
Change from baseline score at two years
Study Arms (2)
Control
ACTIVE COMPARATORwalking at an intense pace
Experimental
EXPERIMENTALosteoporosis specific-oriented training
Interventions
Participants walk 6 kilometers in 1 hour at least 3 times per week
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)
Eligibility Criteria
You may qualify if:
- Postmenopausal woman
- Pharmacological treatment (VitaminD+Calcium)
You may not qualify if:
- Disease or physical-mental condition which prevents to perform the proposed physical exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29040219DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, PT
Study Record Dates
First Submitted
March 14, 2017
First Posted
March 27, 2017
Study Start
February 1, 2011
Primary Completion
July 1, 2013
Study Completion
December 30, 2016
Last Updated
March 27, 2017
Record last verified: 2017-03