Primary Prevention Clinical Trial
Official title:
The Use of Lactate Thresholds to Individualize Accelerometer Cut-points and Objectively Assess Physical Activity Levels in Postmenopausal Women
The purpose of this study is to accurately assess weekly physical activity levels of postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age between 50 and 70 years - Surgical or natural menopause (no menstrual periods during at least the last 6 months) Exclusion Criteria: - Body mass index less than 39kg/m2 (obesity class III) - 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) |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Spain | Centro de Estudios, Investigación y Medicina del Deporte | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Centro de Estudios, Investigación y Medicina del Deporte | Basque Country University |
Spain,
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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. — View Citation
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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. 2016 Oct 31. [Epub ahead of print] — View Citation
Lopes VP, Magalhães 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. — View Citation
Martyn-St James M, Carroll S. High-intensity resistance training and postmenopausal bone loss: a meta-analysis. Osteoporos Int. 2006;17(8):1225-40. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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Vainionpää A, Korpelainen R, Vihriälä E, Rinta-Paavola A, Leppäluoto J, Jämsä T. Intensity of exercise is associated with bone density change in premenopausal women. Osteoporos Int. 2006;17(3):455-63. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Maximum Strength | hand grip, leg and bench press maximum lifted weight (kg) | 1 day | No |
Other | Heart rate variability | the heart rate variability response during the walking-running tests and during the weekly physical activity assessment | an average of 1 month | No |
Primary | Time spent in moderate-to-vigorous physical activities | The time spent in moderate-to-vigorous physical activities during a week (The participants have to wear an accelerometer attatched at the hip on an elastic belt for a period of 7 days) | 1 week | No |
Secondary | accelerometer intensity cut-points | accelerometer activity counts corresponding to each woman´s lactate thresholds will determine each intensity level (These thresholds are determined on the walking-running tests performed on different days with a minimum of one week in between. These tests are independent, they are performed at constant speed during 20min to determine the highest speed at which the lactate concentration remains in a steady state between the minute 10 and 20 of the test) | an average of 1 month | No |
Secondary | Number of vertical acceleration peaks during the day | raw acceleration data will be measured to describe daily exposure to potentially osteogenic vertical impacts (The participants have to wear an accelerometer attatched at the hip on an elastic belt for a period of 7 days) | 1 week | No |
Secondary | aerobic fitness | determination of the speeds corresponding to the lactate thresolds during the walking-running test | an average of 1 month | No |
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