Objective Physical Activity Assesment in Postmenopausal Women
NCT ID: NCT02984553
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2015-11-30
2017-07-31
Brief Summary
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Detailed Description
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Postmenopausal women will be recruited from local advertisements in public health centers. Each woman will perfom on different days a progressive discontinuous submaximal walking-running test and several constant speed tests wearing an accelerometer to identify the individual lactate threshold (LT), the maximal lactate steady state (MLSS) and the corresponding accelerometer activity counts/min (cpm). Participants then will wear an actigraph accelerometer (wGT3X-BT) for seven days.
Linear regression equations will be developed for each participant to determine accelerometer activity counts for each intensity level: 1) sedentary behaviour (\<200 cpm), 2) light intensity (200 cpm to activity counts at LT), 3) moderate intensity (activity counts between LT and MLSS) and 4) vigorous intensity (activity counts \>MLSS). Physical activity levels will be measured using both, individualized approach and Sasaki, Jonh and Freedson´s (2011) absolute cut-points obtained through walking and running activities eliciting 3-6 MET intensities (2689-6166 cpm), considering it a "moderate" effort.
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Surgical or natural menopause (no menstrual periods during at least the last 6 months)
Exclusion Criteria
* Osteoporosis
* Presence of low-trauma fractures or severe arthrosis at hip, knees or feet
* Functional limitation to walk fast or altered gait patters and instability
* Presence of any chronic disesase that would impair the cardiovascular (e.g. myocardial infarction, stroke, chronic heart failure), musculoskeletal (osteoporosis, low-trauma fractures) and respiratory systems (COPD) or any disease or medication known to affect bone metabolism (glucocorticoids)
50 Years
70 Years
FEMALE
Yes
Sponsors
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University of the Basque Country (UPV/EHU)
OTHER
Centro de Estudios, Investigación y Medicina del Deporte
OTHER_GOV
Responsible Party
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Erreka Gil Rey
Principal Investigator
Principal Investigators
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Esteban Gorostiaga, Medicine
Role: STUDY_DIRECTOR
Centro de Estudios, Investigación y Medicina del Deporte
Locations
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Centro de Estudios, Investigación y Medicina del Deporte
Pamplona, Navarre, Spain
Countries
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References
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Vainionpaa A, Korpelainen R, Vihriala E, Rinta-Paavola A, Leppaluoto J, Jamsa T. Intensity of exercise is associated with bone density change in premenopausal women. Osteoporos Int. 2006;17(3):455-63. doi: 10.1007/s00198-005-0005-x. Epub 2006 Jan 11.
Martyn-St James M, Carroll S. High-intensity resistance training and postmenopausal bone loss: a meta-analysis. Osteoporos Int. 2006;17(8):1225-40. doi: 10.1007/s00198-006-0083-4. Epub 2006 Jun 1.
Borer KT, Fogleman K, Gross M, La New JM, Dengel D. Walking intensity for postmenopausal bone mineral preservation and accrual. Bone. 2007 Oct;41(4):713-21. doi: 10.1016/j.bone.2007.06.009. Epub 2007 Jun 26.
Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998 May;30(5):777-81. doi: 10.1097/00005768-199805000-00021.
Ozemek C, Cochran HL, Strath SJ, Byun W, Kaminsky LA. Estimating relative intensity using individualized accelerometer cutpoints: the importance of fitness level. BMC Med Res Methodol. 2013 Apr 1;13:53. doi: 10.1186/1471-2288-13-53.
Sasaki JE, John D, Freedson PS. Validation and comparison of ActiGraph activity monitors. J Sci Med Sport. 2011 Sep;14(5):411-6. doi: 10.1016/j.jsams.2011.04.003. Epub 2011 May 25.
Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
Miller NE, Strath SJ, Swartz AM, Cashin SE. Estimating absolute and relative physical activity intensity across age via accelerometry in adults. J Aging Phys Act. 2010 Apr;18(2):158-70. doi: 10.1123/japa.18.2.158.
Lopes VP, Magalhaes P, Bragada J, Vasques C. Actigraph calibration in obese/overweight and type 2 diabetes mellitus middle-aged to old adult patients. J Phys Act Health. 2009;6 Suppl 1:S133-40. doi: 10.1123/jpah.6.s1.s133.
Hannam K, Deere KC, Hartley A, Clark EM, Coulson J, Ireland A, Moss C, Edwards MH, Dennison E, Gaysin T, Cooper R, Wong A, McPhee JS, Cooper C, Kuh D, Tobias JH. A novel accelerometer-based method to describe day-to-day exposure to potentially osteogenic vertical impacts in older adults: findings from a multi-cohort study. Osteoporos Int. 2017 Mar;28(3):1001-1011. doi: 10.1007/s00198-016-3810-5. Epub 2016 Oct 31.
Beneke R. Methodological aspects of maximal lactate steady state-implications for performance testing. Eur J Appl Physiol. 2003 Mar;89(1):95-9. doi: 10.1007/s00421-002-0783-1. Epub 2003 Jan 21.
Other Identifiers
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ACC-01
Identifier Type: -
Identifier Source: org_study_id